HIV prevention advocates from three major civil society organizations today emphasized the importance of continued research into new HIV prevention options, despite the recent discontinuation of the Phase III effectiveness trials of the microbicide candidate, cellulose sulfate (CS).
CS was one of the four microbicide candidates in Phase III effectiveness trials for prevention of HIV and other sexually transmitted infections. CONRAD, a reproductive health research organization, was conducting Phase III trials to assess its effectiveness in Benin, India, South Africa, and Uganda. Another Phase III trial of CS sponsored by Family Health International was underway in Nigeria. Both sponsors are not-for profit research groups dedicated to advancing health in developing countries.
At the recommendation of their respective Data Safety Monitoring Boards both sponsors chose to discontinue their CS trials after findings from the CONRAD trial suggested that CS might be contributing to an increased risk of HIV infection. Although review of the data from the Nigerian trial found no evidence of increased risk, FHI felt that the only responsible course of action was to halt its study also.
"Of course we wish the results had been different, but learning what doesn't work can be just as important to progress as learning what does work," observed Lori Heise, Director of the Global Campaign for Microbicides (GCM). "It's also reassuring that the independent Data Safety and Monitoring Committees, put in place to identify problems early on in a trial, appear to have worked well. Advocates have been instrumental in pushing for extra mechanisms to help protect participant safety."
African advocates are following the trials conducted in their countries particularly closely, reported Manju Chatani, Coordinator of the African Microbicide Advocacy Group (AMAG). "Scientists scrutinized the data available on cellulose sulfate before the Phase III trials started, including safety results from 11 clinical trials done in Africa, India and the US. All the data suggested that the product was safe and should proceed into Phase III trials," she said.
"This is a setback but it does not detract from the issue that women still don't have the tools they need to protect themselves from HIV", Chatani added. "And African women, especially, urgently need more prevention options. So while we need concrete answers to why this happened as soon as possible, we must continue to research new options so women don't have to ask for permission to protect themselves".
Dr. Kim Dickson, an African physician who serves on the boards of both GCM and AMAG, noted that care and treatment of trial participants are among the top concerns of both groups, along with clinical trial ethics. "At civil society's insistence, the trial investigators forged written agreements in advance to assure that any women who sero-converted while enrolled in the trial would get ongoing care and treatment, including anti-retroviral drugs as needed", she said. "Our priority now is to make sure that advocates' and community questions about this trial and future research are heard and addressed as soon as possible."
Adding his perspective, Director of the AIDS Vaccine Advocacy Coalition (AVAC) Mitchell Warren observed that "Getting a negative result for one product certainly doesn't signal failure for the microbicide field or broader biomedical HIV prevention research effort as a whole. The nature of research is that the information gathered is cumulative", he continued. "Each trial result is a puzzle piece and, together, they make up the complex picture that will show us how to develop successful new HIV prevention tools."
Heise concluded by noting that "The real heroines and heroes in this are the people who enroll in clinical trials because they know how urgently new prevention tools are needed. In Benin, South Africa, and Uganda, the African countries in which the CS trials were being done, between one third and one half of all women of reproductive age are already HIV positive", she added. "It is essential to build on what has been learned here and proceed with the research as rapidly as possible. Millions of women's lives are at stake."
The Global Campaign for Microbicides is an international movement of activists, citizens and not for profit organizations dedicated to accelerating access to new HIV prevention tools, especially for women.
http://www.global-campaign.org.
The African Microbicides Advocacy Group (AMAG) is a coalition of microbicide advocates from organisations and institutions based and/or working in various African countries.
http://www.global-campaign.org/amag.htm.
The AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other HIV prevention options.
http://www.avac.org.
Showing posts with label HIV vaccines. Show all posts
Showing posts with label HIV vaccines. Show all posts
April 16, 2007
British PM Blair, Musician Bono Call On Countries, Corporations To Fulfill Pledges To Africa, Including HIV/AIDS Commitments
British Prime Minister Tony Blair and Irish musician Bono on Friday at a panel discussion at the World Economic Forum in Davos, Switzerland, called on international corporations and donor countries to fulfill their commitments to Africa, including HIV/AIDS pledges, the AP/Sydney Morning Herald reports. "I think it's important that the momentum" surrounding African development efforts is "redoubled" for the next meeting of the Group of Eight industrialized nations, which is scheduled for June in Germany, Blair said, adding, "There are good things that have happened, both on debt cancellation and a lot of work done on HIV and AIDS" (AP/Sydney Morning Herald, 1/27). G8 leaders in July 2005 at the close of their summit in Gleneagles, Scotland, agreed to an immediate doubling of aid to Africa to $50 billion annually in order to fight poverty and disease on the continent. The final summit comminique officially endorsed a debt relief plan, which canceled at least $40 billion in debt owed by the world's 18 poorest nations. The communique also included an agreement on providing universal access to HIV/AIDS treatment, according to Blair (Kaiser Daily HIV/AIDS Report, 7/8/05). In addition, Bono said that although corruption is one of the biggest issues facing Africa, there also has been corruption "north of the equator" in terms of a failure to quickly cancel debt owed by many African countries. He added that debt cancellation should be the focus of the G8 summit in Germany. "As we go into Germany, this is where we find out if we are making progress, and if we fail, it is corruption of the highest order," Bono said. South African President Thabo Mbeki, Liberian President Ellen Sirleaf Johnson, African Development Bank President Donald Kaberuka and Bill & Melinda Gates Foundation co-founder Bill Gates also participated in panel discussion (AP/Sydney Morning Herald, 1/27). Mbeki said that there is a need to use available HIV/AIDS funding more efficiently. "Let's not add new programs and new projects," he said, adding, "[W]e've identified enough of those and agreed on enough of those. Let's remove the things that block implementation" (Xinhua/People's Daily, 1/27). Sirleaf Johnson said that Africans "shouldn't be so poor," adding, "Get rid of the debt and that frees us to get to our objective." Gates said that he is "incredibly hopeful" that efforts to improve the health of Africans are successful and that the continent's economic situation improves (AP/Sydney Morning Herald, 1/27). Blair at the forum also urged leaders to relaunch talks concerning the World Trade Organization-endorsed Doha Declaration, which is aimed at lowering trade barriers to promote economic development in poorer nations. "I think there is every chance the (talks) will get underway again," Blair said, adding, "If it succeeds, it'll be great. If it fails, it'll be catastrophic" (Xinhua/People's Daily, 1/27).
GAVI Initiative
The GAVI Alliance, a partnership aimed at providing increased access to immunizations in developing countries, on Friday at the World Economic Forum announced plans to commit $500 million over three years to strengthen health care infrastructures and train additional health workers in developing nations. The GAVI initiative aims to counter the migration of health workers where its training and immunization programs have been most effective, the Los Angeles Times reports. GAVI, which was launched in 2000 with a grant from the Gates Foundation, also will provide training and support to deliver new vaccines for diseases such as HIV/AIDS and tuberculosis, according to Gates. Julian Lob-Levyt, executive secretary of GAVI, called the lack of health care workers in sub-Saharan Africa a "capacity crisis," adding, "Instead of just training sophisticated doctors and nurses, we will train paramedics" to administer vaccines. It would be more cost effective to provide training and support to health care workers, who likely would remain in their home countries, where their skills are in higher demand, Lob-Levyt said (Piller, Los Angeles Times, 1/27).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
IAVI Report Examines Initiative's History, AIDS Vaccine Timeline
"Imagining a World Without AIDS," International AIDS Vaccine Initiative: The report examines IAVI's history and includes a timeline of milestones in IAVI and AIDS vaccine research. It also reviews various initiatives in the global effort to develop an AIDS vaccine (IAVI, "Imagining a World Without AIDS," December 2006).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Carrington Subsidiary DelSite Signs Technology License Agreement With AriaVax For Development Of HIV Vaccine
Carrington Laboratories, Inc. (Nasdaq: CARN) today announced its wholly-owned subsidiary DelSite Biotechnologies, Inc. has granted a non-exclusive license to AriaVax, Inc., a privately-held biotech company located in Gaithersburg, Maryland, for the purpose of developing and evaluating an investigational vaccine against HIV infection using DelSite's proprietary GelSite(R) polymer delivery technology.
The objective of the program is to develop an effective peptide vaccine formulation that will not only enhance the immune system but will also remain stable at room temperature, be easily shipped and require no refrigeration. Financial terms were not disclosed.
As part of the agreement, DelSite will provide AriaVax with its GelSite(R) polymer and will provide assistance in the vaccine formulation development. GelSite's known safety and chemical properties that enable it to bind to and stabilize proteins and peptides give it the unique ability to deliver a vaccine in either powder form or for reconstitution into a liquid for injection, thus providing the flexibility required for worldwide distribution of such an important vaccine. AriaVax will be responsible for creating the peptide portion of the vaccine candidate cocktail for preclinical studies as well as related testing.
AriaVax's Deadlock(TM) technology allows for the creation of new, small- molecule components of proteins that are termed conformationally-constrained peptides. In preclinical studies these molecules have been shown to elicit the kinds of broadly cross-reactive immune responses against HIV that are desirable in a vaccine. However, the strength and duration of the immune response obtained by AriaVax with its HIV-derived vaccine compounds have thus far been too weak for widespread use. AriaVax believes the GelSite(R) polymer's unique gelling properties could potentially enhance the potency of its vaccine candidates.
The GelSite(R) polymer in the GelVac(TM) formulation, delivered as a nasal powder, was shown to be safe and well tolerated in a Phase I clinical safety study in humans. The delivery device performed as expected and delivered greater than 95 percent of the dose.
HIV infection is well known as a primary health scourge of the twentieth century. With infection rates increasing annually throughout the world, the disease may claim a similar top rating for the twenty-first century. Many experts at top medical establishments throughout the world believe that the only way to control the spread of HIV is with a safe and effective vaccine. However, to date there are no known HIV vaccines capable of providing the levels of sterilizing immunity needed to halt the spread of the disease.
The HIV virus rapidly mutates, and hundreds of different strains are present worldwide. The key challenge for creating a safe and effective anti- HIV vaccine is to elicit in people a single neutralizing immune response that covers all of the world's strains. Molecular components that are common to the different strains of HIV should be useful components of a broadly neutralizing vaccine.
GelSite(R) polymer is a novel, naturally occurring ionic carbohydrate polymer from an organically certified raw material that is capable of forming a gel when brought into contact with body fluids containing calcium. Gelling occurs whether the active compound is delivered as a nasal powder or is injected as a liquid, and this gelling property provides sustained drug/vaccine release in either form.
DelSite has evaluated GelSite(R) polymer for delivery of various protein/peptide therapeutic and vaccine antigens and has completed a series of toxicology studies on the polymer. A drug master file (DMF) has recently been updated with both CDER and CBER of FDA.
A nasal powder formulation (GelVac(TM)) based on this polymer has been developed and successfully tested in the preclinical development of a nasal powder influenza vaccine. Early testing showed the nasal powder vaccine not only induced robust systemic and mucosal immune response but also provided room temperature storage ability that may allow for storage and shipment without requiring cold chain distribution system.
Dr. Yawei Ni, senior scientist at DelSite, stated, "This powder formulation may also be reconstituted for injection and maintains a strong immune-enhancing effect in either form, thus allowing it to meet specific needs of different vaccines. The distinct properties and multiple formulation options provided by the GelSite(R) polymer will further facilitate the development of AriaVax's novel HIV peptide antigens."
In September 2006, DelSite entered into a three-year CRADA with the Laboratory of Cellular Oncology at the National Cancer Institute (NCI) to determine if GelVac(TM) nasal powder delivery platform may be used for delivery of human papillomavirus virus-like particles (HPV VLP) vaccines in a powder dosage form for mucosal immunization. In January 2007, DelSite signed an agreement with EndoBiologics, Inc. for development of a Shigellosis vaccine using the GelSite(R) polymer delivery technology.
About AriaVax
AriaVax, Inc. is a privately held small molecule vaccine company located in Gaithersburg, Maryland. AriaVax is using its proprietary Deadlock(TM) technology to create novel peptide-based vaccine candidates for a variety of indications. A portion of the HIV work described here has been supported by grants from the National Institutes of Health of The Department of Health and Human Services.
About DelSite
Carrington's wholly owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs. DelSite is currently developing a nasal powder vaccine using its GelVac(TM) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from the Department of Health and Human Services. For more information, visit http://www.delsite.com.
About Carrington
Carrington Laboratories, Inc., is an ISO 9001-certified, research-based, green biopharmaceutical and consumer products company currently utilizing naturally-occurring complex carbohydrates, from organically certified raw materials to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards.
Carrington and DelSite technologies are protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. For more information, visit http://www.carringtonlabs.com.
Certain statements in this release concerning Carrington may be forward- looking. Actual events will be dependent upon a number of factors and risks including, but not limited to: subsequent changes in plans by the Company's management; delays or problems in formulation, manufacturing, distribution, production and/or launch of new finished products; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company's filings with the Securities & Exchange Commission, including the Form 10-Q, filed November 14, 2006.
Carrington Laboratories, Inc.
http://www.carringtonlabs.com
The objective of the program is to develop an effective peptide vaccine formulation that will not only enhance the immune system but will also remain stable at room temperature, be easily shipped and require no refrigeration. Financial terms were not disclosed.
As part of the agreement, DelSite will provide AriaVax with its GelSite(R) polymer and will provide assistance in the vaccine formulation development. GelSite's known safety and chemical properties that enable it to bind to and stabilize proteins and peptides give it the unique ability to deliver a vaccine in either powder form or for reconstitution into a liquid for injection, thus providing the flexibility required for worldwide distribution of such an important vaccine. AriaVax will be responsible for creating the peptide portion of the vaccine candidate cocktail for preclinical studies as well as related testing.
AriaVax's Deadlock(TM) technology allows for the creation of new, small- molecule components of proteins that are termed conformationally-constrained peptides. In preclinical studies these molecules have been shown to elicit the kinds of broadly cross-reactive immune responses against HIV that are desirable in a vaccine. However, the strength and duration of the immune response obtained by AriaVax with its HIV-derived vaccine compounds have thus far been too weak for widespread use. AriaVax believes the GelSite(R) polymer's unique gelling properties could potentially enhance the potency of its vaccine candidates.
The GelSite(R) polymer in the GelVac(TM) formulation, delivered as a nasal powder, was shown to be safe and well tolerated in a Phase I clinical safety study in humans. The delivery device performed as expected and delivered greater than 95 percent of the dose.
HIV infection is well known as a primary health scourge of the twentieth century. With infection rates increasing annually throughout the world, the disease may claim a similar top rating for the twenty-first century. Many experts at top medical establishments throughout the world believe that the only way to control the spread of HIV is with a safe and effective vaccine. However, to date there are no known HIV vaccines capable of providing the levels of sterilizing immunity needed to halt the spread of the disease.
The HIV virus rapidly mutates, and hundreds of different strains are present worldwide. The key challenge for creating a safe and effective anti- HIV vaccine is to elicit in people a single neutralizing immune response that covers all of the world's strains. Molecular components that are common to the different strains of HIV should be useful components of a broadly neutralizing vaccine.
GelSite(R) polymer is a novel, naturally occurring ionic carbohydrate polymer from an organically certified raw material that is capable of forming a gel when brought into contact with body fluids containing calcium. Gelling occurs whether the active compound is delivered as a nasal powder or is injected as a liquid, and this gelling property provides sustained drug/vaccine release in either form.
DelSite has evaluated GelSite(R) polymer for delivery of various protein/peptide therapeutic and vaccine antigens and has completed a series of toxicology studies on the polymer. A drug master file (DMF) has recently been updated with both CDER and CBER of FDA.
A nasal powder formulation (GelVac(TM)) based on this polymer has been developed and successfully tested in the preclinical development of a nasal powder influenza vaccine. Early testing showed the nasal powder vaccine not only induced robust systemic and mucosal immune response but also provided room temperature storage ability that may allow for storage and shipment without requiring cold chain distribution system.
Dr. Yawei Ni, senior scientist at DelSite, stated, "This powder formulation may also be reconstituted for injection and maintains a strong immune-enhancing effect in either form, thus allowing it to meet specific needs of different vaccines. The distinct properties and multiple formulation options provided by the GelSite(R) polymer will further facilitate the development of AriaVax's novel HIV peptide antigens."
In September 2006, DelSite entered into a three-year CRADA with the Laboratory of Cellular Oncology at the National Cancer Institute (NCI) to determine if GelVac(TM) nasal powder delivery platform may be used for delivery of human papillomavirus virus-like particles (HPV VLP) vaccines in a powder dosage form for mucosal immunization. In January 2007, DelSite signed an agreement with EndoBiologics, Inc. for development of a Shigellosis vaccine using the GelSite(R) polymer delivery technology.
About AriaVax
AriaVax, Inc. is a privately held small molecule vaccine company located in Gaithersburg, Maryland. AriaVax is using its proprietary Deadlock(TM) technology to create novel peptide-based vaccine candidates for a variety of indications. A portion of the HIV work described here has been supported by grants from the National Institutes of Health of The Department of Health and Human Services.
About DelSite
Carrington's wholly owned subsidiary DelSite Biotechnologies, Inc. is developing its proprietary GelSite(R) technology designed to provide controlled release of peptide and protein-based drugs. DelSite is currently developing a nasal powder vaccine using its GelVac(TM) formula with the H5N1 avian flu antigen. This work is partially funded by two grants from the Department of Health and Human Services. For more information, visit http://www.delsite.com.
About Carrington
Carrington Laboratories, Inc., is an ISO 9001-certified, research-based, green biopharmaceutical and consumer products company currently utilizing naturally-occurring complex carbohydrates, from organically certified raw materials to manufacture and market products for mucositis, radiation dermatitis, wound and oral care, as well as to manufacture and market the nutraceutical raw material Manapol(R) and cosmetic raw material Hydrapol(TM). Carrington also manufactures and markets consumer products and manufactures quality products for other companies. Manufacturing operations comply with cGMP standards.
Carrington and DelSite technologies are protected by more than 130 patents in 26 countries. Select products carry the CE mark, recognized by more than 20 countries around the world. For more information, visit http://www.carringtonlabs.com.
Certain statements in this release concerning Carrington may be forward- looking. Actual events will be dependent upon a number of factors and risks including, but not limited to: subsequent changes in plans by the Company's management; delays or problems in formulation, manufacturing, distribution, production and/or launch of new finished products; changes in the regulatory process; changes in market trends; and a number of other factors and risks described from time to time in the Company's filings with the Securities & Exchange Commission, including the Form 10-Q, filed November 14, 2006.
Carrington Laboratories, Inc.
http://www.carringtonlabs.com
April 15, 2007
30+ AIDS Vaccine Clinical Trials In 24 Countries, Research Occurring On Every Continent
The International AIDS Vaccine Initiative's (IAVI) January 2007 Annual Issue of VAX, an editorially independent bulletin on AIDS vaccine research published by IAVI, reports that 13 new preventive AIDS vaccine trials were initiated in eight countries around the world in 2006. There are now more than 30 trials ongoing in 24 countries, across every continent.
This annual publication provides the only comprehensive listing of all AIDS vaccine clinical trial activity worldwide.
Last year saw the start of the first AIDS vaccine trials in the Russian Federation and Zambia, and three countries in sub-Saharan Africa - Kenya, Uganda, and Tanzania - also initiated new trials. The United States, United Kingdom, Sweden and Peru began new trials in 2006 as well. Many of these trials were sponsored by new research groups, including the Karolinska Institute in Sweden, St. George's University of London and the Moscow Institute of Immunology.
All of the new trials that began last year were either Phase I or Phase I/II trials designed to evaluate the safety and immunogenicity of the candidate vaccines. "Although these new trials are early-stage, they will provide critical information over the coming years that will help drive the field's R&D agenda. We hope to begin to see even more novel vectors, as well as approaches that target neutralizing antibodies in the next few years," said CEO and President of IAVI, Dr. Seth Berkley.
IAVI and its collaborators are currently conducting four ongoing trials in India, Kenya, Rwanda, Uganda, South Africa and the United States. In 2006, IAVI launched a Phase II trial in Uganda and Zambia, part of a multi-site study that also included three sites in South Africa. The South Africa, Uganda and Zambia trial sites are now fully enrolled with data expected later this year.
Two of the most advanced trials underway in 2007 are from Sanofi-Pasteur and Merck & Co., Inc. Data from Merck's ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in 2008 or 2009 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field's future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 4.3 million people were newly infected with HIV last year - bringing the total number of HIV-infected individuals to 40 million people worldwide. Explosive HIV epidemics also continue in Eastern Europe and Central Asia. Throughout the world, a preventive AIDS vaccine remains one of the greatest hopes for stemming the pandemic.
###
The 2006 IAVI VAX Map, which provides detailed information on all ongoing preventive AIDS vaccine trials, is available at http://www.iavireport.org/Vax/VAXJanuary2007.asp.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, The John D. Evans Foundation, The New York Community Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, Ireland, The Netherlands, Norway, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines, Google Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see http://www.iavi.org/.
Contact: Katherine Moore
International AIDS Vaccine Initiative
This annual publication provides the only comprehensive listing of all AIDS vaccine clinical trial activity worldwide.
Last year saw the start of the first AIDS vaccine trials in the Russian Federation and Zambia, and three countries in sub-Saharan Africa - Kenya, Uganda, and Tanzania - also initiated new trials. The United States, United Kingdom, Sweden and Peru began new trials in 2006 as well. Many of these trials were sponsored by new research groups, including the Karolinska Institute in Sweden, St. George's University of London and the Moscow Institute of Immunology.
All of the new trials that began last year were either Phase I or Phase I/II trials designed to evaluate the safety and immunogenicity of the candidate vaccines. "Although these new trials are early-stage, they will provide critical information over the coming years that will help drive the field's R&D agenda. We hope to begin to see even more novel vectors, as well as approaches that target neutralizing antibodies in the next few years," said CEO and President of IAVI, Dr. Seth Berkley.
IAVI and its collaborators are currently conducting four ongoing trials in India, Kenya, Rwanda, Uganda, South Africa and the United States. In 2006, IAVI launched a Phase II trial in Uganda and Zambia, part of a multi-site study that also included three sites in South Africa. The South Africa, Uganda and Zambia trial sites are now fully enrolled with data expected later this year.
Two of the most advanced trials underway in 2007 are from Sanofi-Pasteur and Merck & Co., Inc. Data from Merck's ongoing Phase IIb test-of-concept trial with its adeno-5 vector vaccine candidate is expected in 2008 or 2009 and will provide preliminary information on the efficacy of this type of vaccine candidate. These results will have significant implications for the field's future research and development efforts. The company will also soon be starting an additional Phase IIb trial with the same candidate in South Africa.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimates that 4.3 million people were newly infected with HIV last year - bringing the total number of HIV-infected individuals to 40 million people worldwide. Explosive HIV epidemics also continue in Eastern Europe and Central Asia. Throughout the world, a preventive AIDS vaccine remains one of the greatest hopes for stemming the pandemic.
###
The 2006 IAVI VAX Map, which provides detailed information on all ongoing preventive AIDS vaccine trials, is available at http://www.iavireport.org/Vax/VAXJanuary2007.asp.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 24 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI's financial and in-kind supporters include the Alfred P. Sloan Foundation, the Bill & Melinda Gates Foundation, The John D. Evans Foundation, The New York Community Trust, The Rockefeller Foundation, The Starr Foundation, The William and Flora Hewlett Foundation; the Governments of Canada, Denmark, Ireland, The Netherlands, Norway, Sweden, the United Kingdom, and the United States, the Basque Autonomous Government as well as the European Union; multilateral organizations such as The World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines, Google Inc., Merck & Co., Inc. and Pfizer Inc; leading AIDS charities such as Broadway Cares/Equity Fights AIDS and Until There's A Cure Foundation; other private donors such as The Haas Trusts; and many generous individuals from around the world. For more information, see http://www.iavi.org/.
Contact: Katherine Moore
International AIDS Vaccine Initiative
Human Trial Results Show Excellent Safety Data, Positive Immune Responses From GeoVax's DNA/MVA AIDS Vaccines
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax's AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease ("AIDS") caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
-- Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
-- Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
-- Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
-- Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
-- Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
-- Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
-- Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
-- Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
-- Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
-- Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
Preclinical Trial Results Of GeoVax's Vaccines Demonstrate Potential To Protect Against Development Of AIDS
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company, today reported successful results from a preclinical trial using GeoVax's vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome ("AIDS") in non-human primates. The data demonstrate the effectiveness of GeoVax's DNA/MVA vaccines in controlling the Simian ("SIV") AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's vaccines.
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus- infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus- infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
March 7, 2007
Human Trial Results Show Excellent Safety Data, Positive Immune Responses From GeoVax's DNA/MVA AIDS Vaccines
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax's AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease ("AIDS") caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
-- Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
-- Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
-- Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
-- Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
-- Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
-- Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
-- Indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
-- Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
-- Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
-- Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non- human primates for more than 3 1/2 years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV- 1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
Preclinical Trial Results Of GeoVax's Vaccines Demonstrate Potential To Protect Against Development Of AIDS
GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), an Atlanta-based biotechnology company, today reported successful results from a preclinical trial using GeoVax's vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome ("AIDS") in non-human primates. The data demonstrate the effectiveness of GeoVax's DNA/MVA vaccines in controlling the Simian ("SIV") AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's vaccines.
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus- infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus- infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
GeoVax Labs, Inc.
http://www.geovax.com/
March 5, 2007
Preclinical Results Of Geovax's AIDS Vaccines Demonstrate Potential To Protect Against Disease
GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, have reported successful results from a preclinical trial using GeoVax's vaccines for the therapeutic treatment and prevention of Acquired Immunodeficiency Disease Syndrome ("AIDS") in non-human primates. The data demonstrate the effectiveness of GeoVax's DNA/MVA vaccines in controlling the Simian ("SIV") AIDS virus through immune responses raised by the vaccines. These promising results have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's vaccines.
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
###
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
Contact: Melanie Nimrodi
Financial Relations Board
In this trial, two monkeys were infected with the SIV AIDS virus and then placed on drug therapy. Thereafter, once early drug therapy had temporarily reduced virus levels, the monkeys were vaccinated with the SIV version of GeoVax's DNA/MVA vaccines. Six weeks after vaccination, drug treatment was discontinued. The SIV virus levels temporarily rose in the vaccinated individuals, but were later "controlled" (reduced to much lower levels) by immune responses raised by the vaccines.
The reduction of virus levels in the blood stream of these AIDS virus-infected non-human primates has continued for more than a year to date. Vaccination with the GeoVax DNA/MVA vaccines has curtailed the development of AIDS and its associated debilitating effects, resulting in healthy, asymptomatic individuals. The monkeys have gained weight and have not required any additional drug therapy.
"The results of this trial demonstrate the long-term promise of our vaccines in treating HIV-AIDS," said Don Hildebrand, CEO of GeoVax Labs. "Our preclinical trials, coupled with encouraging data from two ongoing human trials, help validate the science behind our vaccines and provide the impetus for accelerating the planning of Phase II human trials for our preventive vaccines."
The ability to vaccinate those already infected with the AIDS virus, thereby inhibiting the virus' progressive and debilitating effects, would allow individuals to fight off normal infections, live longer and maintain a more normal lifestyle. Such a vaccine, if approved for distribution, would be considerably more cost-effective and without the same side effects associated with current drug treatment programs.
The promising results from this trial have resulted in preliminary plans to conduct human therapeutic studies utilizing GeoVax's AIDS vaccines with the hope of extending the length and quality of life in people already infected with the AIDS virus.
###
These studies were conducted at Emory University and were supported by funding from the National Institutes of Health.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
Contact: Melanie Nimrodi
Financial Relations Board
AVAC Applauds Commencement Of First HIV Vaccine Efficacy Trial In Africa
The AIDS Vaccine Advocacy Coalition (AVAC) heralds today's launch of the first African efficacy trial of an experimental HIV vaccine as a critical, strategic and historically- significant step in the search for an AIDS vaccine.
The trial, which is known as Phambili (a Xhosa word meaning "moving forward") or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.
"South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace," said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).
The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.
"The timing of the Phambili trial launch is a bold decision," said Warren. "There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries."
"As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population," Warren said.
"Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and public-private partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate," Warren said.
While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step Study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.
About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options. For more information, visit http://www.avac.org.
AIDS Vaccine Advocacy Coalition
http://www.avac.org
The trial, which is known as Phambili (a Xhosa word meaning "moving forward") or HVTN 503, was launched today in South Africa by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN) of the US National Institutes of Health.
"South Africa and the partner agencies in this study are demonstrating tremendous leadership. With the stakes as high as they are in the epidemic, accelerating large-scale efficacy trials in the countries and communities that need an HIV vaccine the most is the kind of forward-looking, strategic decision-making that the field needs and should embrace," said Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC).
The same vaccine candidate, which has been developed by Merck Research Laboratories, is currently being tested in another efficacy trial being conducted in various sites in North and South America, the Caribbean and Australia. The data from this study, known as the Step Study, are not yet known. Phambili has been initiated before the conclusion of the Step Study to help speed the progress of gathering additional important data in sub-Saharan Africa.
"The timing of the Phambili trial launch is a bold decision," said Warren. "There is an urgent need to identify new AIDS prevention strategies as quickly as possible; this sequence of trials will help move the field forward as quickly as possible. These two trials will combine to shed light on whether this vaccine candidate has the potential to be a truly global vaccine that can eventually be used in both developed and developing countries."
"As this trial moves forward, AVAC also hopes that this vaccine candidate will also be studied among adolescents. Adolescents are at great risk of HIV infection, and AVAC strongly supports the inclusion of adolescents in future trials so that we can get answers as quickly as possible for this priority population," Warren said.
"Finding an effective AIDS vaccine will not happen in one isolated sector or country, but from international collaborations between industry, government agencies, academia, and public-private partnerships. Phambili is an excellent example of putting public funds to good use to test a promising vaccine candidate," Warren said.
While there have been a significant number of small and mid-size safety studies conducted in sub-Saharan Africa, Phambili is the first study that is designed to provide information on whether or not a vaccine protects against HIV infection or helps to blunt HIV disease. Neither the Step Study nor the Phambili trial has been designed as the final study of this vaccine candidate; if there are indications of efficacy, additional studies will be conducted to confirm this preliminary finding.
About AVAC: Founded in 1995, the AIDS Vaccine Advocacy Coalition (AVAC) is a non-profit, community- and consumer-based organization that uses public education, policy analysis, advocacy and community mobilization to accelerate the ethical development and global delivery of AIDS vaccines and other prevention options. For more information, visit http://www.avac.org.
AIDS Vaccine Advocacy Coalition
http://www.avac.org
Africa's First Large-Scale HIV Vaccine Study Launches
The launch of the first large-scale study to evaluate a candidate HIV vaccine on the African continent was announced today by study collaborators in the United States and South Africa. The trial will involve up to 3,000 participants at five sites throughout South Africa and is expected to continue for four years.
The sites are part of the HIV Vaccine Trials Network (HVTN), which is headquartered at Fred Hutchinson Cancer Research Center in Seattle and supported through a cooperative agreement with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The trial sites also receive funding from the South African AIDS Vaccine Initiative.
"This trial will answer several major scientific issues that face all of us in the field of HIV-vaccine development," said Lawrence Corey, M.D., principal investigator of the HVTN and a member of the Hutchinson Center's Clinical Research Division. "It will determine the usefulness of vaccines that induce high immune response to the parts of the virus that are similar between different strains of HIV-1."
The study is known as a phase IIb or "test of concept" efficacy trial because it enables researchers to determine whether the test vaccine prevents HIV infection, results in lower HIV levels in those who become infected after vaccination or both. In addition, investigators for the South Africa vaccine trial will determine if this vaccine, which is based on clade B HIV, has the potential to protect against the clade C virus, the subtype prevalent in South Africa. Phase IIb trials cannot be used to support licensure of a vaccine, however, the data from this study will guide whether this type of vaccine approach offers promise to interrupt the continued spread of HIV.
Additionally, the South African study is likely to provide important new data on how the test vaccine might work in a predominantly heterosexual HIV epidemic, how well the vaccine works in women, and whether the vaccine works in populations with pre-existing immunity to the viral vector used in the vaccine, according to Corey, who is also head of the Infectious Diseases Program and Virology Division at the University of Washington School of Medicine.
"South Africa is an excellent location for this trial due to the high levels of infection coupled with the good clinical infrastructure, including internationally recognized immunology laboratories, a well-established national vaccine initiative and experience in running clinical trials," said James Kublin, M.D., M.P.H., one of study's lead investigators, along with Glenda Gray, MBBCH, FCPaeds (SA), of the Perinatal HIV Research Unit, University of the Witwatersrand, based at the Chris Hani Baragwanath Hospital in Soweto. "Community involvement and education initiatives in South Africa are robust and mature, and they are essential for running trials involving thousands of volunteers," said Kublin, who is a staff physician in the Hutchinson Center's Clinical Research Division and a clinical associate professor of health services at the University of Washington School of Public Health and Community Medicine.
The test vaccine, known as the MRKAd5 HIV-1 trivalent vaccine, is manufactured by Merck & Co., Inc. and already has been studied for several years in phase I and II trials involving thousands of volunteers in the Americas, Africa and Australia to evaluate safety and immune responses. In those previous trials this vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers.
Merck Research Laboratories developed the test vaccine that is based on an adenovirus -- a common cold virus that has been modified so that it cannot cause a cold in humans or be passed from person to person. The adenovirus is the carrier or vector which transports copies of three HIV genes called gag, pol and nef. The vaccine is made in the laboratory and does not contain live HIV. The test vaccine therefore cannot cause infection.
The hope is that these HIV genes will produce a cellular immune response to HIV and cause the body to make killer cells that are programmed to recognize and destroy cells that are infected with HIV. The studies already completed with this vaccine suggest that it is generally well tolerated and that the response of the immune system or immunogenicity is high.
In South Africa, the vaccine trial is called "Phambili," which means "moving forward" in the Xhosa language. Volunteers will be healthy HIV negative males and females, aged 18 to 35 years, who are sexually active and not pregnant.
The trial design will compare the test vaccine to a placebo (a harmless substance) and, to eliminate bias, neither volunteers nor researchers will know who receives the vaccine and who receives the placebo. The trial will last about four years. The trial has been approved by the South African Medicines Control Council and the South African Department of Agriculture, and has been reviewed by the US Food and Drug Administration. Approval has also been given or is pending by institutional ethics and bio-safety committees at all the trial sites. In addition, there will be an independent Data and Safety Monitoring Board, a group of independent experts, not affiliated with Merck and Co. Inc, the HVTN, or the clinical trial investigators, who will carefully monitor the safety of the trial participants.
A cornerstone of this vaccine trial is a commitment to the highest level of preventive care for all participants. To meet this commitment, all participants will receive extensive, state-of-the-art risk-reduction counseling on a regular basis throughout the study, and high-quality male and female condoms will be provided to participants. Participants also will be provided access to treatment for any sexually transmitted infection acquired during the study. Recent research has shown that men who are circumcised are less likely to become HIV infected when they have sexual relations with women. As a result, access to medical circumcision also will be provided to male participants who choose to undergo the procedure.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit http://www.fhcrc.org.
The HIV Vaccine Trials Network is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company. Working with industry and government, the HVTN seeks to expedite and coordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials. The HVTN is funded and supported by the NIAID of the NIH, an agency of the U.S. Department of Health and Human Services (DHHS). The HVTN comprises more than 25 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle.
Fred Hutchinson Cancer Research Center
http://www.fhcrc.org
The sites are part of the HIV Vaccine Trials Network (HVTN), which is headquartered at Fred Hutchinson Cancer Research Center in Seattle and supported through a cooperative agreement with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The trial sites also receive funding from the South African AIDS Vaccine Initiative.
"This trial will answer several major scientific issues that face all of us in the field of HIV-vaccine development," said Lawrence Corey, M.D., principal investigator of the HVTN and a member of the Hutchinson Center's Clinical Research Division. "It will determine the usefulness of vaccines that induce high immune response to the parts of the virus that are similar between different strains of HIV-1."
The study is known as a phase IIb or "test of concept" efficacy trial because it enables researchers to determine whether the test vaccine prevents HIV infection, results in lower HIV levels in those who become infected after vaccination or both. In addition, investigators for the South Africa vaccine trial will determine if this vaccine, which is based on clade B HIV, has the potential to protect against the clade C virus, the subtype prevalent in South Africa. Phase IIb trials cannot be used to support licensure of a vaccine, however, the data from this study will guide whether this type of vaccine approach offers promise to interrupt the continued spread of HIV.
Additionally, the South African study is likely to provide important new data on how the test vaccine might work in a predominantly heterosexual HIV epidemic, how well the vaccine works in women, and whether the vaccine works in populations with pre-existing immunity to the viral vector used in the vaccine, according to Corey, who is also head of the Infectious Diseases Program and Virology Division at the University of Washington School of Medicine.
"South Africa is an excellent location for this trial due to the high levels of infection coupled with the good clinical infrastructure, including internationally recognized immunology laboratories, a well-established national vaccine initiative and experience in running clinical trials," said James Kublin, M.D., M.P.H., one of study's lead investigators, along with Glenda Gray, MBBCH, FCPaeds (SA), of the Perinatal HIV Research Unit, University of the Witwatersrand, based at the Chris Hani Baragwanath Hospital in Soweto. "Community involvement and education initiatives in South Africa are robust and mature, and they are essential for running trials involving thousands of volunteers," said Kublin, who is a staff physician in the Hutchinson Center's Clinical Research Division and a clinical associate professor of health services at the University of Washington School of Public Health and Community Medicine.
The test vaccine, known as the MRKAd5 HIV-1 trivalent vaccine, is manufactured by Merck & Co., Inc. and already has been studied for several years in phase I and II trials involving thousands of volunteers in the Americas, Africa and Australia to evaluate safety and immune responses. In those previous trials this vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers.
Merck Research Laboratories developed the test vaccine that is based on an adenovirus -- a common cold virus that has been modified so that it cannot cause a cold in humans or be passed from person to person. The adenovirus is the carrier or vector which transports copies of three HIV genes called gag, pol and nef. The vaccine is made in the laboratory and does not contain live HIV. The test vaccine therefore cannot cause infection.
The hope is that these HIV genes will produce a cellular immune response to HIV and cause the body to make killer cells that are programmed to recognize and destroy cells that are infected with HIV. The studies already completed with this vaccine suggest that it is generally well tolerated and that the response of the immune system or immunogenicity is high.
In South Africa, the vaccine trial is called "Phambili," which means "moving forward" in the Xhosa language. Volunteers will be healthy HIV negative males and females, aged 18 to 35 years, who are sexually active and not pregnant.
The trial design will compare the test vaccine to a placebo (a harmless substance) and, to eliminate bias, neither volunteers nor researchers will know who receives the vaccine and who receives the placebo. The trial will last about four years. The trial has been approved by the South African Medicines Control Council and the South African Department of Agriculture, and has been reviewed by the US Food and Drug Administration. Approval has also been given or is pending by institutional ethics and bio-safety committees at all the trial sites. In addition, there will be an independent Data and Safety Monitoring Board, a group of independent experts, not affiliated with Merck and Co. Inc, the HVTN, or the clinical trial investigators, who will carefully monitor the safety of the trial participants.
A cornerstone of this vaccine trial is a commitment to the highest level of preventive care for all participants. To meet this commitment, all participants will receive extensive, state-of-the-art risk-reduction counseling on a regular basis throughout the study, and high-quality male and female condoms will be provided to participants. Participants also will be provided access to treatment for any sexually transmitted infection acquired during the study. Recent research has shown that men who are circumcised are less likely to become HIV infected when they have sexual relations with women. As a result, access to medical circumcision also will be provided to male participants who choose to undergo the procedure.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit http://www.fhcrc.org.
The HIV Vaccine Trials Network is an international collaboration of scientists and institutions whose goal is to accelerate the search for an HIV vaccine by sharing trial results and facilitating parallel, concurrent testing. The HVTN is a unique hybrid that combines the depth and diversity of the academic community and the flexibility of a commercial drug company. Working with industry and government, the HVTN seeks to expedite and coordinate the trial process, advancing vaccine candidates and building a body of knowledge around HIV vaccine trials. The HVTN is funded and supported by the NIAID of the NIH, an agency of the U.S. Department of Health and Human Services (DHHS). The HVTN comprises more than 25 research institutions worldwide, coordinated from its headquarters at the Fred Hutchinson Cancer Research Center in Seattle.
Fred Hutchinson Cancer Research Center
http://www.fhcrc.org
March 4, 2007
Human Trial Results Show Excellent Safety Data, From Geovax's DNA/MVA AIDS Vaccines
GeoVax Labs, Inc. (OTC BB: GOVX), an Atlanta-based biotechnology company, today reported successful early results from two ongoing AIDS prevention Phase I human vaccine trials. Results from the first low dose trial indicate a good safety profile as well as positive immune responses in human volunteers receiving 1/10th dose of GeoVax's AIDS vaccine. Results from a second larger full dose trial also indicate a good safety profile in participants. The GeoVax vaccines being tested are designed to prevent the development of Acquired Immunodeficiency Disease ("AIDS") caused by the virus known as HIV-1 by vaccinating individuals prior to infection with the AIDS virus.
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
* Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
* indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
* Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
* Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
* Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non-human primates for more than 3 Đ’Đ… years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV-1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
###
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
Contact: Melanie Nimrodi
Financial Relations Board
Early results from GeoVax's preventative HIV/AIDS vaccine human trials:
* Demonstrate a very acceptable safety profile in an ongoing 1/10th dose trial begun in April, 2006
* indicate that as low as 1/10th of a full dose of GeoVax's HIV/AIDS vaccine stimulates potentially protective anti-HIV-1 immune responses in the majority of vaccine recipients
* Suggest an acceptable safety profile in an ongoing full dose trial begun Sept 2006
* Suggest that a full dose of the vaccine will stimulate an even better immune response in recipients participating in the full dose trial; data is expected later in 2007
* Support accelerated planning for a large Phase II human trial including more than 300 participants across North and South America and the Caribbean and with an earlier start date than originally anticipated
The 1/10th dose trial, begun April, 2006, is evaluating GeoVax's AIDS vaccines primarily for their safety and potential efficacy as a preventative vaccine administered to people prior to infection with the HIV-1 virus, thus preventing the development of AIDS. A positive human immune response to the vaccine is indicated by the presence of antibodies and T cells (white blood cells) that recognize and control viral infections.
"We are very encouraged by the positive immune responses in six human volunteers receiving only 1/10th of a dose of vaccine," said Dr. Harriet Robinson, GeoVax's Chief Scientific Advisor and developer of the AIDS vaccine. "This trial group consisted of 11 volunteers, with two individuals that received no vaccine as part of the blinded study. In this group, only 1/10th of a dose of GeoVax's DNA vaccine was administered at week 0 and at week 8 to prime the immune response. The immune response was then boosted by administration of 1/10th of a dose of GeoVax's MVA vaccine at week 16 and again at week 24."
The vaccine response was determined in tests conducted on human blood samples collected after vaccination. These assays were conducted at the Emory University Vaccine Center under the guidance of Dr. Harriet Robinson.
Based on the excellent safety demonstrated in the 1/10th dose vaccine trial, a full dose human trial started in September, 2006. Thus far, the trial has enrolled 36 volunteers. Thirty of the volunteers received the vaccine, while six control subjects received a placebo (no vaccine). The full dose of AIDS vaccine approximates the dose size that protected 22 of 23 (96%) of non-human primates for more than 3 Đ’Đ… years against development of AIDS. The immune response generated in the majority of volunteers receiving 1/10th dose of GeoVax's vaccines suggests that the vaccines, when administered at full dose, may elicit outstanding responses.
More information will be released on the full dose trial when available later in 2007. GeoVax's AIDS vaccines contain only part of the HIV-1 virus and cannot cause AIDS. These vaccines contain the three major genes of the HIV-1/AIDS virus and mimic actual virus infections by producing non-infectious HIV-like particles in vaccinated individuals.
###
The human trials, utilizing GeoVax's AIDS vaccines, are being conducted by the HIV Vaccine Trials Network (HVTN), based in Seattle, Washington. The HVTN, which is funded and supported by the National Institutes of Health, is the largest worldwide clinical trials program devoted to the development and testing of HIV/AIDS vaccines. Preclinical work enabling development of the clinical evaluation of GeoVax's DNA and MVA vaccines was also funded and supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
Safe Harbor Statement
All statements in this news release that are not statements of historical fact are forward-looking statements. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, whether; GeoVax can develop these vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be determined to be safe for use in humans, GeoVax's vaccines will be effective in preventing AIDS in humans, the vaccines will receive the regulatory approvals necessary to be licensed and marketed, GeoVax can raise the required capital to complete development of its vaccines, there is development of competitive products that may be more effective or easier to use than GeoVax's products, and other factors over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. Certain matters discussed in this news release are forward looking statements involving certain risks and uncertainties including, without limitations, risks detailed in the Companies Securities and Exchange Commission filings and reports.
Contact: Melanie Nimrodi
Financial Relations Board
First Large-Scale HIV Vaccine Trial In South Africa
A large-scale clinical trial of a candidate HIV vaccine - which previously showed promise in smaller studies in the United States and elsewhere - has now opened in South Africa. The study plans to enroll up to 3,000 HIV-negative men and women, making it the largest African HIV vaccine trial to date.
Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.
"Our best hope of ending the AIDS epidemic is a safe and effective vaccine," says NIH Director Elias A. Zerhouni, M.D. "To achieve that goal requires the concerted effort of governments, scientists and private industry as well as participation by well-informed volunteers."
"We applaud the South Africans for bringing this important trial to fruition. This international partnership exemplifies the model of collaboration needed to defeat HIV/AIDS," says NIAID Director Anthony S. Fauci, M.D.
In South Africa the trial is called Phambili ("moving forward"). Also known as HVTN 503, it is a Phase IIb "test-of-concept" trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure.
In smaller trials, the vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers. To date, more than 1,800 people have received at least one injection. Two years ago, the first Phase IIb trial of the vaccine opened at sites in the United States, Canada, South America, Australia and the Caribbean (see http://www3.niaid.nih.gov/news/newsreleases/2005/mercktrial.htm), areas where a subtype of HIV called clade B predominates. That trial is ongoing.
As in that study, the main objectives of HVTN 503 are to determine whether the candidate vaccine can prevent HIV infection or, in those who do become infected, lower the level of HIV early on. Additionally, the new trial will determine if the vaccine, which is based on clade B HIV, has the potential to protect against the HIV clade C subtype prevalent in South Africa. Immune responses in the first several hundred volunteers will be assessed to ensure the vaccine induces promising immune responses in this population against the clade C virus before proceeding to full enrollment.
Study volunteers must be healthy, sexually active, HIV-negative men and women, ages 18 to 35 years old. Investigators will assign them at random to receive either the test vaccine or an inactive placebo injection. The trial is double-blind, meaning that neither the researchers nor the volunteers know which a participant has received. All volunteers will be regularly counseled about ways to reduce their risk of acquiring HIV, and they will be given condoms. Access to care and treatment for sexually transmitted infections will be provided, and because recent findings indicate that medical circumcision can reduce the risk of HIV transmission from women to men, access to medical circumcision will also be provided to male participants who desire it.
In South Africa, the trial is led by Glenda Gray, MBBCH, FCPaeds (SA), of the Perinatal HIV Research Unit, University of the Witwatersrand, based at the Chris Hani Baragwanath Hospital in Soweto. James Kublin, M.D., M.P.H., of Fred Hutchinson Cancer Research Center, Seattle, serves as study co-chair. The study is expected to recruit volunteers at five sites in South Africa, located in Soweto, Cape Town, Klerksdorp, Medunsa and Durban.
According to Dr. Gray, the study team has actively sought community endorsement of and support for this clinical trial, both of which are critical to its success. "Our communities here in South Africa are faced with the burden of HIV on a daily basis, and the trial investigators and study team have spent years developing a rapport with the community so that together we can move forward in our quest to identify improved approaches to prevent new HIV infections."
The test vaccine contains a weakened adenovirus that serves as a carrier for three clade B HIV genes. Adenoviruses are among the main causes of upper respiratory tract ailments such as the common cold. Because the vaccine contains only three HIV genes housed in weakened adenoviruses, study participants cannot become infected with HIV or get a respiratory infection from the vaccine. The study aims to determine if the HIV genes will induce a cellular immune response, producing immune cells that recognize and kill cells infected with HIV.
The South African Medicines Control Council, the South African Department of Agriculture and the U.S. Food and Drug Administration have reviewed the trial and allowed the study to proceed. In order to conduct the trial, sites also are required to obtain institutional ethics and biosafety committee approvals.
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NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.
NIAID-Sponsored Vaccine Trial (HVTN 503) in the Republic of South Africa Questions and Answers http://www3.niaid.nih.gov/news/QA/503qa.htm
HIV Vaccine Trials Network (HVTN) http://www.hvtn.org/
South African AIDS Vaccine Initiative (SAAVI) http://www.saavi.org.za/
Contact: NIAID News Office
NIH/National Institute of Allergy and Infectious Diseases
Conducted jointly by the South African AIDS Vaccine Initiative (SAAVI) and the HIV Vaccine Trials Network (HVTN), the trial is supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study vaccine, provided by Merck & Co. Inc. (Whitehouse Station, NJ), contains copies of only three HIV genes, not the entire virus, so it is impossible for a trial volunteer to become infected from the vaccine.
"Our best hope of ending the AIDS epidemic is a safe and effective vaccine," says NIH Director Elias A. Zerhouni, M.D. "To achieve that goal requires the concerted effort of governments, scientists and private industry as well as participation by well-informed volunteers."
"We applaud the South Africans for bringing this important trial to fruition. This international partnership exemplifies the model of collaboration needed to defeat HIV/AIDS," says NIAID Director Anthony S. Fauci, M.D.
In South Africa the trial is called Phambili ("moving forward"). Also known as HVTN 503, it is a Phase IIb "test-of-concept" trial, the first such vaccine study in South Africa. This type of trial is designed to provide preliminary information on vaccine efficacy and thus enable researchers to decide whether or not to conduct a larger Phase III efficacy trial that could lead to licensure.
In smaller trials, the vaccine was found to be safe and to stimulate cellular immune responses against HIV in more than half of volunteers. To date, more than 1,800 people have received at least one injection. Two years ago, the first Phase IIb trial of the vaccine opened at sites in the United States, Canada, South America, Australia and the Caribbean (see http://www3.niaid.nih.gov/news/newsreleases/2005/mercktrial.htm), areas where a subtype of HIV called clade B predominates. That trial is ongoing.
As in that study, the main objectives of HVTN 503 are to determine whether the candidate vaccine can prevent HIV infection or, in those who do become infected, lower the level of HIV early on. Additionally, the new trial will determine if the vaccine, which is based on clade B HIV, has the potential to protect against the HIV clade C subtype prevalent in South Africa. Immune responses in the first several hundred volunteers will be assessed to ensure the vaccine induces promising immune responses in this population against the clade C virus before proceeding to full enrollment.
Study volunteers must be healthy, sexually active, HIV-negative men and women, ages 18 to 35 years old. Investigators will assign them at random to receive either the test vaccine or an inactive placebo injection. The trial is double-blind, meaning that neither the researchers nor the volunteers know which a participant has received. All volunteers will be regularly counseled about ways to reduce their risk of acquiring HIV, and they will be given condoms. Access to care and treatment for sexually transmitted infections will be provided, and because recent findings indicate that medical circumcision can reduce the risk of HIV transmission from women to men, access to medical circumcision will also be provided to male participants who desire it.
In South Africa, the trial is led by Glenda Gray, MBBCH, FCPaeds (SA), of the Perinatal HIV Research Unit, University of the Witwatersrand, based at the Chris Hani Baragwanath Hospital in Soweto. James Kublin, M.D., M.P.H., of Fred Hutchinson Cancer Research Center, Seattle, serves as study co-chair. The study is expected to recruit volunteers at five sites in South Africa, located in Soweto, Cape Town, Klerksdorp, Medunsa and Durban.
According to Dr. Gray, the study team has actively sought community endorsement of and support for this clinical trial, both of which are critical to its success. "Our communities here in South Africa are faced with the burden of HIV on a daily basis, and the trial investigators and study team have spent years developing a rapport with the community so that together we can move forward in our quest to identify improved approaches to prevent new HIV infections."
The test vaccine contains a weakened adenovirus that serves as a carrier for three clade B HIV genes. Adenoviruses are among the main causes of upper respiratory tract ailments such as the common cold. Because the vaccine contains only three HIV genes housed in weakened adenoviruses, study participants cannot become infected with HIV or get a respiratory infection from the vaccine. The study aims to determine if the HIV genes will induce a cellular immune response, producing immune cells that recognize and kill cells infected with HIV.
The South African Medicines Control Council, the South African Department of Agriculture and the U.S. Food and Drug Administration have reviewed the trial and allowed the study to proceed. In order to conduct the trial, sites also are required to obtain institutional ethics and biosafety committee approvals.
###
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.
NIAID-Sponsored Vaccine Trial (HVTN 503) in the Republic of South Africa Questions and Answers http://www3.niaid.nih.gov/news/QA/503qa.htm
HIV Vaccine Trials Network (HVTN) http://www.hvtn.org/
South African AIDS Vaccine Initiative (SAAVI) http://www.saavi.org.za/
Contact: NIAID News Office
NIH/National Institute of Allergy and Infectious Diseases
Russia To Allocate 40M - 50M Dollars For HIV Vaccine Research Center, Health Official Says
Russia plans to allocate 40 million dollars to 50 million dollars from its federal budget to a regional HIV vaccine development center between fiscal years 2007 and 2009, Gennady Onishchenko, the country's chief medical officer, said on Tuesday, RIA Novosti reports (RIA Novosti, 2/6). According to Onishchenko, seven research institutions in Russia have been investigating HIV/AIDS in the country, one of which will become the primary research center under the regional body. Leaders from the Group of Eight industrialized nations in July 2006 at the close of their summit released a final communique that endorsed the Russian center, which will coordinate HIV vaccine research in Eastern Europe and Central Asia. G8 leaders also agreed to establish a global center for HIV vaccine research (Kaiser Daily HIV/AIDS Report, 7/25/06). According to Onishchenko, the country is drafting a government resolution that proposes the $40 million to $50 million in funding (RIA Novosti, 2/6).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
G7 Nations Plan To Adopt Vaccine Purchase Plan For Diseases Such As HIV/AIDS, TB, Malaria
The Group of Seven industrialized nations on Friday plans to sign an agreement to provide 1.5 billion dollars to develop vaccines for diseases -- including HIV/AIDS, TB and malaria -- that largely affect developing countries, the government of Italy announced on Tuesday, Reuters reports. Under the program, donor countries will pledge to buy vaccines that are being developed at a preferential price when they are available (Vagnoni, Reuters, 2/6). This would create a financial incentive for drug companies to develop vaccines for diseases that largely affect developing countries, Bloomberg reports (Krause-Jackson, Bloomberg, 2/6). Canada, Italy, Norway and the United Kingdom plan to make funding pledges on Friday. According to Italian government sources, Italy plans to pledge $500 million; the United Kingdom is expected to pledge $400 million; and Canada and Norway are expected to pledge $200 million each, Reuters reports. Officials from the G7 countries plan to explain the program to Pope Benedict XVI on Friday ahead of the G7 meeting in Essen, Germany, according to the Italian economy ministry (Reuters, 2/6). Leaders of the Group of Eight industrialized nations at their summit in July 2006 did not act on an opportunity to adopt a similar advance market commitment plan aimed at funding the development of vaccines for diseases such as HIV/AIDS, TB and malaria (Kaiser Daily HIV/AIDS Report, 7/19/06).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Large-Scale Trial Of Merck's Experimental HIV Vaccine To Begin In South Africa
A large-scale trial of Merck's experimental HIV vaccine, called MRKAd5 HIV-1, is set to begin in South Africa, the Wall Street Journal reports (Wall Street Journal, 2/9). The trial -- announced on Thursday and to be conducted by the South African AIDS Vaccine Initiative and the HIV Vaccine Trials Network -- is supported by the National Institute of Allergy and Infectious Diseases. It will involve 3,000 HIV-negative men and women, making it the largest HIV trial to be conducted in Africa to date. The vaccine cannot infect participants with the virus because it contains copies of three HIV genes and not live HIV (NIAID release, 2/8). The trial aims to test whether the vaccine can either prevent HIV transmission or lower levels of HIV in people who contract the virus. The study also likely will provide new information about how the vaccine might work in a heterosexual population; how it might work in women; and whether it would be effective in populations with pre-existing immunity to the viral vector used in the vaccine, I-Net Bridge/Mail and Guardian reports (I-Net Bridge/Mail and Guardian, 2/8). Researchers also are seeking to determine whether the vaccine, which is based on the B strain of the virus, would be effective against the C strain of HIV -- the prevalent strain in South Africa. During the four-year trial -- which will enroll healthy, sexually active people ages 18 to 35 -- some participants will be given the vaccine and some will be given a placebo version. The trial will not enroll pregnant women (BBC News, 2/8). All participants will receive regular counseling on how to reduce their risk of contracting the virus and will be given condoms. Participants also will be provided with access to care and treatment for sexually transmitted infections. In addition, because of recent studies showing that male circumcision can reduce a man's risk of HIV infection, circumcision will be provided for men who request it (SAAVI release, 2/8). The vaccine already has been tested for safety and immune response in Africa, the Americas and Australia. South Africa's Medicines Control Council and the country's Department of Agriculture have approved the trial, and FDA in the U.S. has reviewed it (BBC News, 2/8). The trial will be run by researchers at the Fred Hutchinson Cancer Research Center and the Perinatal HIV Research Unit at the University of Witwatersrand. If this trial is successful, another likely will be launched in three to five years that would involve 10,000 or more participants, according to James Kublin of the Hutchinson Center (King, Seattle Times, 2/8).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Monogram Provides Update On Trofile(TM) Co-Receptor Tropism Assay
Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator Pfizer, Inc. (NYSE: PFE) has separately announced today that the U.S. Food and Drug Administration (FDA) has granted priority review status and the European Medicines Agency (EMEA) has agreed to the accelerated review procedure for the marketing authorization applications for maraviroc, potentially the first in a new class of HIV treatments. Pfizer submitted the U.S. and EU applications in December 2006 for maraviroc as treatment for antiretroviral-experienced patients with a specific strain of HIV (CCR5-tropic HIV-1).
Priority Review is granted by FDA to products that, if approved, would be a significant improvement compared to existing approved therapies. The goal for reviewing a product with Priority Review status is six months from the filing date, rather than the typical review period of up to one year.
Monogram's co-receptor tropism assay, Trofile(TM), was used for patient selection for maraviroc's clinical development program, and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use on a global basis. "Throughout the clinical development of maraviroc, physicians and patients relied on Trofile to predict a patient's likelihood for response," said Monogram CEO William Young. "We believe this new model of drug and diagnostic collaborations will create a more personalized and effective treatment for patients with HIV."
Maraviroc is designed to work differently from other available HIV medications. CCR5 antagonists block the virus from gaining access into healthy cells via the CCR5 co-receptor, a common pathway for viral entry. Monogram's Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients. Pfizer expects to present the results of a phase III study of maraviroc at an upcoming scientific meeting.
Maraviroc and other entry inhibitors currently in development come at a time when increasing drug resistance makes treating HIV more difficult than ever. Highly sensitive and precise diagnostic tools are playing an ever more important role in the development of new therapeutic approaches that give new hope to physicians and patients running low on options.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection, expected protection provided by patents, and activities expected to occur in connection with the Pfizer collaboration. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that regulatory authorities may not require or recommend a molecular diagnostic for patient selection for an HIV drug, risks related to the implementation of the collaboration with Pfizer; risks related to our ability to recognize revenue from activities under the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors, entry inhibitors or integrase inhibitors; the use of our Trofile co-receptor tropism assay for patient use in the event of approval of any CCR5 inhibitors; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services, whether the draft guidance on Multivariate Index Assays recently issued by FDA applies to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer and Merrill Lynch debt agreements; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
Trofile is a trademark of Monogram Biosciences, Inc.
Monogram Biosciences, Inc.
http://www.monogrambio.com
Priority Review is granted by FDA to products that, if approved, would be a significant improvement compared to existing approved therapies. The goal for reviewing a product with Priority Review status is six months from the filing date, rather than the typical review period of up to one year.
Monogram's co-receptor tropism assay, Trofile(TM), was used for patient selection for maraviroc's clinical development program, and the two companies are engaged in a collaboration agreement to make Monogram's assay available for patient use on a global basis. "Throughout the clinical development of maraviroc, physicians and patients relied on Trofile to predict a patient's likelihood for response," said Monogram CEO William Young. "We believe this new model of drug and diagnostic collaborations will create a more personalized and effective treatment for patients with HIV."
Maraviroc is designed to work differently from other available HIV medications. CCR5 antagonists block the virus from gaining access into healthy cells via the CCR5 co-receptor, a common pathway for viral entry. Monogram's Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients. Pfizer expects to present the results of a phase III study of maraviroc at an upcoming scientific meeting.
Maraviroc and other entry inhibitors currently in development come at a time when increasing drug resistance makes treating HIV more difficult than ever. Highly sensitive and precise diagnostic tools are playing an ever more important role in the development of new therapeutic approaches that give new hope to physicians and patients running low on options.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection, expected protection provided by patents, and activities expected to occur in connection with the Pfizer collaboration. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that regulatory authorities may not require or recommend a molecular diagnostic for patient selection for an HIV drug, risks related to the implementation of the collaboration with Pfizer; risks related to our ability to recognize revenue from activities under the collaboration with Pfizer; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors, entry inhibitors or integrase inhibitors; the use of our Trofile co-receptor tropism assay for patient use in the event of approval of any CCR5 inhibitors; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services, whether the draft guidance on Multivariate Index Assays recently issued by FDA applies to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer and Merrill Lynch debt agreements; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements.
Trofile is a trademark of Monogram Biosciences, Inc.
Monogram Biosciences, Inc.
http://www.monogrambio.com
Wealthy Nations Launch Vaccine Purchase Plan For Diseases Such As HIV/AIDS, TB, Malaria
Officials from a group of wealthy nations on Friday launched a $1.5 billion plan to provide and develop vaccines for diseases -- including HIV/AIDS, tuberculosis and malaria -- that largely affect developing countries, the New York Times reports (Rosenthal, New York Times, 2/10). Under the program, donor countries will pledge to buy vaccines that are being developed at a preferential price when they are available. This would create a financial incentive for drug companies to develop vaccines for diseases that largely affect developing countries (Kaiser Daily HIV/AIDS Report, 2/8). Italy, Canada, Norway, Russia and the United Kingdom have committed the funding for the program, which was launched in Rome (New York Times, 2/10). The program, known as the Advance Market Commitment, will phase out its funding after seven to 10 years, and vaccine manufacturers will be required to continue selling their products to developing countries at the discounted price that was established during the process. Vaccines must meet the standards of efficacy, safety and cost-effectiveness laid out by the GAVI Alliance, the World Bank and an assessment committee (Falconi, AP/CP/Globe and Mail, 2/9). According to the GAVI Alliance and the World Bank, the program is expected to prevent the deaths of 5.4 million children by 2030. The first phase of the plan will focus on the pneumococcal vaccine, which prevents pneumonia in children (New York Times, 2/10). World Bank President Paul Wolfowitz, who attended the launch, said the plan's success requires that the vaccines reach patients, are administered effectively and their results are monitored. He added that the international community should help developing countries improve health care infrastructures to increase access to services (Castelfranco, VOA News, 12/9).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Related Editorial, Opinion Piece
- Washington Post: Even though the plan is a "relatively cheap, market-based approach" to vaccine development, the U.S. contribution is "[n]otably absent," a Washington Post editorial says. This is a "mistake" that policymakers should "correct as the initiative proceeds," the editorial says (Washington Post, 2/12).
- British Finance Minister Gordon Brown, Independent: The new vaccine purchase plan is a "workable, powerful and cost-effective mechanism" that "turns a vague hope for a medical breakthrough into an immediate reality," Brown writes in an Independent opinion piece. He adds that he believes this year will see a "breakthrough in the way we develop and produce life-saving vaccines" (Brown, Independent, 2/10).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Spray Drying Technique Created For TB Vaccine
Bioengineers and public health researchers have developed a novel spray drying method for preserving and delivering the most common tuberculosis (TB) vaccine. The low-cost and scaleable technique offers several potential advantages over conventional freezing procedures, such as greater stability at room temperature and use in needle-free delivery. The spray drying process could one day provide a better approach for vaccination against TB and help prevent the related spread of HIV/AIDS in the developing world.
The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.
"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuĐ“©rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."
BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.
"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."
The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.
"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."
Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.
"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."
###
Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.
Contact: Michael Patrick Rutter
Harvard University
The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.
"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuĐ“©rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."
BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.
"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."
The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.
"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."
Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.
"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."
###
Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.
Contact: Michael Patrick Rutter
Harvard University
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