April 16, 2007
Medical Services International Moves Into Additional Countries In Africa
The distributors have indicated that this could result in the purchase of up to an additional 2,000,000 VScan test kits per year. The Company believes that by the end of 2007, it will be the largest supplier of HIV, TB, Dengue Fever and Malaria rapid test kits in the world.
About VScan
The VScan rapid test kit is a single use, disposable, accurate, cost effective, easy to use test for the screening of HIV 1&2, Hepatitis B&C, Tuberculosis (TB), Dengue Fever, West Nile, Syphilis, Malaria and Prostate cancer. The kits cannot be sold in Canada.
Medical Services International Inc trades in the United States on the NQB Pinksheets under the symbol "MSITF". For further information go to http://www.medicalservicesintl.com or http://www.minerva-biotech.com.
Certain statements in this press release are "forward-looking statements" within the meaning of the Private Securities Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that may cause results to differ materially. Such risks, uncertainties and other factors include but are not limited to new economic conditions, risk in product development, market acceptance of new products and continuing product demand, level of competition and other factors described in Company reports an other filings with regulatory bodies.
Medical Services International Inc
http://www.medicalservicesintl.com
USP Publishes Standards For Medications For Neglected Diseases
"Public standards for such medicines are urgently needed to help ensure that patients in all parts of the world have access to good quality medications," said Roger L. Williams, M.D., USP executive vice president and CEO. "These international standards will make it easier for healthcare organizations in countries without sufficient regulatory and pharmacopeial resources of their own to ensure the quality and purity of medications."
The World Health Organization estimates that 1 billion people -- one sixth of the world's population -- suffer from neglected tropical diseases. Widespread counterfeiting and distribution of sub-standard drugs has worsened this situation.
The initial two drugs included in the International Standards program are used in the treatment of HIV-AIDS: Abacavir Sulfate, and Efavirenz. These monographs are posted in draft form, with a 90-day period for public comment that ends on April 30, 2007. Instructions for submitting comments are at http://www.usp.org/internationalStandards/. Monographs for drugs used to treat malaria will be added shortly as part of the ongoing program.
USP's standards are widely recognized internationally as authoritative, science-based, and credible. They are developed through a process that is transparent and open to public comment. As the world's only private pharmacopeia, USP has the unique ability to work across borders, giving it the ability to set voluntary standards for medicines used outside the United States.
The worldwide public health benefits of the International Standards initiative include:
-- Supporting the effort to provide quality drugs to patients with the greatest need;
-- Helping ensure that medicines for neglected infectious diseases in international commerce meet a high standard of quality;
-- Ensuring the availability of science-based public standards that help prevent counterfeit, sub-standard, or adulterated medicines; and
-- Assisting foreign regulatory bodies, customs officials, purchasing agents, and others by providing information for testing the quality of medicines within a country or in international commerce.
For more information on USP's international standards, visit http://www.usp.org/internationalStandards/.
USP -- Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standards-setting organization that advances public health and improves patient safety by ensuring good pharmaceutical care. USP standards, which are recognized worldwide, are developed through a unique process of public involvement by volunteers representing pharmacy, medicine, and other healthcare professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information about USP and its standards-setting activities, visit http://www.usp.org/aboutUSP/media.
United States Pharmacopeia
http://www.usp.org/internationalStandards/
Thai Health Minister To Break Patents, Issue Compulsory Licenses For Antiretroviral, Heart Disease Drugs
"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.
Violence Against Women Fueling Spread Of HIV Worldwide, Undermining Prevention Efforts, Advocates Say
"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.
DANIDA, UNFPA, Radio Station Launch Program In Vietnam To Provide Youth With HIV/AIDS Education
"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.
Guyanese Health Ministry To Provide $450,000 For HIV/AIDS Programs Nationwide
"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.
Global AIDS Alliance Thanks Congress For Increasing Funding For AIDS, TB And Malaria Programs
Congress has recognized that global disease is a true emergency in which bold US leadership can be truly effective. The AIDS epidemic is still spreading, with 4.3 million new infections this past year. Extremely drug- resistant TB is a major new threat, especially in southern Africa. Malaria is a major killer of children and a contributing factor in the spread of HIV/AIDS.
Dr. Paul Zeitz, Executive Director of the Global AIDS Alliance, made the following statement:
"This funding increase will save millions of lives and provide urgently needed care and support for millions of orphaned and vulnerable children. We thank all members of Congress responsible for this funding increase, in particular Senate Majority Whip Richard Durbin (D-IL), Senator Patrick Leahy (D-VT), Senator Robert Byrd (D-WV), Speaker Nancy Pelosi (D-CA), Representative David Obey (D-WI), House Majority Leader Steny Hoyer (D-MD), and Representative Barbara Lee (D-CA). These legislators are putting the US on the right side of history by fully backing the fight against disease. This is exactly the kind of bold leadership we need in the US Congress.
"With the increase for the Global Fund, the US is much better placed to go to other countries and urge them to increase their contributions to the Fund. We will need Germany, Japan and others to now reciprocate by upping their contributions; otherwise the global goal of universal access to AIDS-related services by 2010 will remain out of reach.
"A new, extremely dangerous form of TB has emerged, and much more US funding will be required to combat it, and quickly. Extremely drug-resistant tuberculosis (XDR-TB) threatens to undermine much of our progress in fighting HIV/AIDS. The emergency is so great that the Congress should use the upcoming Supplemental Budget for 2007 to channel $300 million to address this disease threat.
"A wide range of humanitarian, student and religious groups worked together to urge Congress to provide the funding agreed to this week. People across the United States also appealed to Congress to provide this funding, and Congress responded with vision and leadership.
"Increases are also urgently needed for other global poverty programs, as well as the response to AIDS in the United States, and we hope Congress provides these as a part of the FY 2008 appropriations process."
Global AIDS Alliance
http://www.globalaidsalliance.org
Uganda AIDS Commission Announces Plans To Test 500,000 Annually, Provide Treatment For 90% Of HIV-Positive People By 2012
"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.
Cellulose Sulfate Microbicide Trial Stopped - Statement Developed By The World Health Organization And UNAIDS
Cellulose sulfate was one of four compounds being evaluated in large-scale studies of effectiveness among women at high risk of HIV infection. Currently there are three other Phase III microbicide studies under way. The Carraguard study (sponsored by the Population Council and conducted in three sites in South Africa) is nearing completion and results are expected by the end of 2007. Another product, PRO 2000, is being tested in one study in five sites in South Africa, Tanzania and Uganda (results expected in 2009) as well as in a second study in seven sites in Malawi, South Africa, Zambia and Zimbabwe (results expected in 2008). In this second study a further compound, BufferGel, (a vaginal defence enhancer) is being tested. All the other compounds mentioned are products that block HIV infection - known as HIV entry inhibitors - and have a similar presumed mechanism of action.
Data from these clinical trials will be indispensable to the researchers and developers of emerging and future microbicide candidates. It is important for the microbicide field to understand why cellulose sulfate was associated with a higher risk of HIV infection than the placebo product. At present there is no explanation for this higher rate of transmission of HIV. The need to continue research to find a user-controlled means of preventing HIV infection in women is urgent. Despite the effectiveness and availability of condoms, the HIV epidemic continues to spread and the search for a safe and effective microbicide is a vital part of the effort to stem the spread of the HIV epidemic.
*Microbicides are products being developed to be used by women to reduce the transmission of HIV during sexual intercourse. A microbicide could take the form of a gel, cream, film, tablet or sponge, or be contained in a vaginal ring that releases the active ingredient gradually.
http://www.who.int
New York City Health Department Approves $1.57M Contract To Distribute 20M Condoms To Curb HIV/AIDS
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Leading Advocates Express Support For Microbicide Research, Despite Disappointing Clinical Trial Results
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.
Caribbean Summit On HIV/AIDS 'Long Overdue,' Opinion Piece Says
"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.
British PM Blair, Musician Bono Call On Countries, Corporations To Fulfill Pledges To Africa, Including HIV/AIDS Commitments
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.
China To Launch HIV/AIDS Prevention Campaign Focusing On Migrant Workers
"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.
Democrats Propose $463.5B Spending Bill; Allocate $1.3B Increase To Fund International HIV/AIDS, TB, Malaria Programs
"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.
Attention Drawn To The World's Health Inequalities
This is the philosophy behind Worldmapper, a collection of cartograms that rescale the size of territories in proportion to the value being mapped (examples of values that are mapped are public health spending, malaria cases, HIV prevalence, and number of physicians).
Worldmapper Poster 213, for example, shows public health spending--most of Africa appears tiny on this map. Another cartogram (Worldmapper Poster 229) shows global malaria cases - in this case Africa appears enormous.
In a paper in PLoS Medicine, Professor Dorling describes why he and his colleagues launched the Worldmapper project (http://www.worldmapper.org/). The project is a collaboration between researchers at the Social and Spatial Inequalities Research Group of the University of Sheffield and Mark Newman from the Center for the Study of Complex Systems at the University of Michigan in the United States. During the course of 2006, the project aimed to create 365 new world maps, embed them in explanatory posters, and provide raw data and technical notes on many of the most prominent of the world major datasets published mainly by various United Nations organizations. This information is all freely available on the Worldmapper website.
"What I think matters most," says Professor Dorling, "are the new ways of thinking that we foster as we redraw the images of the human anatomy of our planet in these ways. What do we need to be able to see - so that we can act?"
###
Citation: Dorling D (2007) Worldmapper: The human anatomy of a small planet. PLoS Med 4(1): e1.
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CONTACT:
Daniel Dorling
University of Sheffield
Department of Geography
Western Bank
Sheffield, S10 2TN United Kingdom
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/
Contact: Andrew Hyde
Public Library of Science
HIV/AIDS Advocates Protest Novartis' Case Challenge India Patent Law
Protests in India; Washington, D.C.
Hundreds of HIV/AIDS advocates on Monday protested in New Delhi, India, against the Novartis patent challenge, the AP/Herald Tribune reports. MSF, along with Oxfam International, has gathered about 250,000 signatures for a petition asking Novartis to drop the case (AP/International Herald Tribune, 1/29). Several HIV/AIDS advocacy groups in Washington, D.C., also protested on Monday, the AFP/France24 reports. David Bryden, communications director for Global AIDS Alliance, said that the advocates were attempting to deliver a golden miniature coffin to a Novartis office in the district but that they were turned away. The demonstrators chanted, "Patient rights, not patent rights" and, "Novartis greed kills people in need; Drop the case now," AFP/France 24 reports. The protest symbolizes the "fatal consequence" of Novartis' action for people who rely on India for generic drugs, Bryden said (AFP/France24, 1/29).
APM's "Marketplace" on Monday reported on the protests. The segment includes comments from Bryan Liang -- a professor at the California Western School of Law who advises pharmaceutical companies on competition, pricing and access -- and Chan Park, a patient advocate with the Lawyers Collective HIV/AIDS Unit (Levitt, "Marketplace," APM, 1/29). Audio of the segment is available online.
"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.
Thai Health Ministry Breaks Patent, Issues Compulsory License For Abbott's Antiretroviral Kaletra
"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.
Senior WHO Official Nabarro Leads New Shortlist Of Candidates For Global Fund Executive Director Position, Financial Times Reports
- Kazatchkine;
- Julio Frenk, former health minister of Mexico and a finalist in last year's search for a new WHO head;
- Nabarro;
- Alex Coutinho, manager of AIDS treatment programs in Uganda;
- Carol Bellamy, president of World Learning and former UNICEF director;
- Kunio Waki, deputy executive director of the U.N. Population Fund;
- Jack Chow, former U.S. Department of State senior official who also oversaw WHO AIDS programs;
- Arata Kochi, head of WHO's Malaria Department; and
- Brad Herbert, former Global Fund director of operations (Kaiser Daily HIV/AIDS Report, 1/9).
"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.
Trial On Anti-HIV Gel For Women Stopped
The cellulose sulfate microbicide gel is one of four currently in a third phase of testing by clinical trials. Trials on the other three products have not been stopped.
The trial was being conducted on over 1,300 women in Benin, India, South Africa and Uganda. Another trial in Nigeria, sponsored by Family Health International, using the same product has also been stopped as a precautionary measure, although there is no news as to whether this trial was giving similar results.
The World Health Organization said today that "This is a disappointing and unexpected setback in the search for a safe and effective microbicide that can be used by women to protect themselves against HIV infection."
CONRAD, the sponsors of the trial that has been stopped, is a cooperating agency of USAID, whose Chief of Research, Technology and Utilization Division, Office of Population and Reproductive Health, Jeff Spieler, said in a prepared statement that he was "surprised and disappointed by these findings given the pre-clinical effectiveness and safety profile of CS and its safety profile demonstrated in Phase I trials."
He said he was hopeful that the other three products in Phase III trials would yield good results and help to push forward the fight to help women protect themselves against HIV infection.
The other three microbicide products in Phase III trials are: Carraguard, which is being tested in 3 South African sites and is expected to finish in 2007; PRO 2000, which is being tested in two studies, one due to finish in 2008 and another in 2009, also in a range of African countries. And one of the PRO 2000 studies is also testing the third microbicide, BufferGel.
Apart from BufferGel, which is a vaginal defence enhancer, the other Phase III products, including cellulose sulfate, are known as HIV entry inhibitors - they block the infection route for HIV.
The cellulose sulfate microbicide gel in the trial that has been stopped is manufactured by the Canadian company Polydex Pharmaceuticals.
Microbicides are a range of products for use by women. Each product acts in its own way to reduce the transmission of HIV by sexual intercourse. The products are available in a range of forms such as gels, creams, tablets, sponges, films, or in a vaginal ring that releases the agent over a period of time.
They are considered an effective route for HIV prevention because studies show that significant numbers of African men will not use condoms for a range of reasons and women are not able to insist that they do.
Click here for cellulose sulfate microbicide Clinical Trial Summary (CONRAD site).
Click here for more information on microbicides (Alliance for Microbicide Development).
Written by: Catharine Paddock
Writer: Medical News Today
Initial Product RED Contributions To Global Fund Flowing To Africa, Financial Times Reports
"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.
Jamaican Senate Passes Motion To Prohibit HIV Testing Among Prospective Employees
"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.
Libya Proposes Plan To Release Medical Workers Sentenced To Death In HIV Infection Case
"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
"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
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
HIV Dementia Alarmingly High In Africa
In the first study of HIV dementia on the African continent using rigorous neurological and neuropsychological tests, 31 percent of a small but presumably representative group of HIV-positive patients in Uganda were found to have HIV dementia, according to Ned Sacktor, M.D., a Johns Hopkins neurologist and senior author of a multi-institutional study that will be published Jan. 29 in Neurology.
HIV dementia is defined as memory, learning, behavioral and motor disabilities that interfere with normal daily life and in extreme cases lead to total disability and a bedridden state. Unlike Alzheimer's- and stroke-induced dementia, HIV dementia is treatable and potentially reversible with the same antiretroviral medication that is used to treat the infection. Treatment can even restore completely normal cognitive function to some of those affected.
The study looked at 178 subjects in Kampala, Uganda, from September 2003 to January 2004. Seventy-eight were HIV-positive patients recruited from the Infectious Disease Clinic in Mulago Hospital, Makerere University, and 100 were HIV-negative individuals recruited from the AIDs Information Center who were used to obtain normative data for the cognitive tests.
In diagnosing HIV dementia, researchers looked at medical history and the results of a series of comprehensive neurological and neuropsychological tests and functional assessments.
"Clearly, large-scale testing would have to be conducted before we know the global reach of HIV dementia, but this study sends a clear message that it exists in high proportions in sub-Saharan Africa and is an under-recognized condition that needs to be studied and treated," Sacktor says.
Of the estimated 40 million adults and children worldwide who are living with HIV infection, an estimated 27 million live in sub-Saharan Africa, according to Sacktor.
"If the rate we saw in our study translates across sub-Saharan Africa, we're looking at more than 8,000,000 people in this region with HIV dementia," says Sacktor.
Sacktor says an extremely high rate of HIV dementia in Africa and other poor regions of the world adds enormously to the social and economic burden of their populations and governments. Dementia not only disrupts jobs and adds to the cost of care, but also interferes with a patient's ability to adhere to a regular course of antiretroviral medication, thus increasing the risk of drug resistance. People with dementia also are less likely to practice safe sex.
Before antiretroviral medications were available in the United States, the U.S. rate of HIV dementia was similar to what was discovered in this study in Uganda, says Sacktor. Unfortunately, he says, only 20 percent of people infected with HIV in the world are getting treatment.
"We hope studies like these will shed additional light on the devastating problem of HIV in resource-limited countries like Uganda and encourage more programs that bring much-needed medication to these poor regions of the world," Sacktor says.
Sacktor says there's little accurate data about HIV dementia patients in other parts of the world --- current estimates of the number of HIV-positive patients who have dementia range from 9 percent to 54 percent.
Additional researchers who worked on the study include Matthew Wong, M.D., from the University of Virginia; Richard Skolasky, M.A., from Johns Hopkins; Kevin Robertson, Ph.D., from the University of North Carolina; Noeline Nakasujja, M.B., Ch.B., Seggane Musisi, M.B., Ch.B., and Elly Katabira, M.B., Ch.B., from Makerere University, Kampala, Uganda; and Allan Ronald, M.D., from the University of Manitoba, Winnipeg, Canada.
Johns Hopkins Medical Institutions
901 S. Bond St., Ste 550
Baltimore, MD 21231
United States
http://www.hopkinsmedicine.org/
April 15, 2007
TB Becoming Difficult To Treat In Vietnam Because Of TB/HIV Coinfection, Health Official Says
"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.
Investment Level In HIV Prevention Programs Related To HIV Incidence In The United States
The researchers found that from the beginning of the epidemic until 1985 (when new infections peaked), incidence of HIV predicted investment levels. During this period, society responded to increasing levels of infection with more investment in prevention programs. Things changed in the mid 1980s when investment levels began to predict incidence. That is, as the nation continued to increase the funding of HIV prevention programs, HIV dropped substantially from 160,000 infections per year to about 40,000 infections per year. In the early 1990s, as the level of investment (adjusted for inflation) flattened out with little annual change, so too did the number of new infections per year. This suggested to the researchers that level investment yields level incidence.
"Our analysis helps explain why the number of new HIV infections has remained at 40,000 per year for over 15 years," said David R. Holtgrave, PhD, chair of the Department of Health Behavior and Society at the Bloomberg School of Public Health and lead author of the study. "Investment levels have predicted HIV incidence since the mid-1980s. If we want to lower infections further in the U.S., these analyses suggest we should consider increasing our national investment. Yes, that may seem expensive, but HIV medical care easily tops $20,000 per patient per year. Therefore, funding of effective, scientifically sound HIV prevention services are likely to have a very favorable return on investment in terms of both lives and dollars saved."
Holtgrave noted that the analysis was based on historical data and is not a prospective trial of prevention effectiveness. Therefore, it is subject to methodological limitations. Nevertheless, he said it provides substantial indications of a strong relationship between the amount of national investment in HIV prevention and levels of new infections per year in the country. The paper"HIV Incidence and CDC's HIV Prevention Budget An Exploratory Correlational Analysis" was co-authored by Jennifer Kates, MPA, of the Kaiser Family Foundation.
Contact: Tim Parsons
Johns Hopkins University Bloomberg School of Public Health
Lawsuit Over AIDS Memorial Quilt Reflects Changes In U.S. HIV/AIDS Epidemic, New York Times Reports
Comments
Michael Petrelis, a San Francisco-based writer and HIV/AIDS advocate, said, "The quilt was very effective in the late '80s and early '90s for AIDS awareness," adding, "On the other hand, there's hundreds and thousands of people that need a housing subsidy, just trying to keep a roof over their head. Should we be putting our time and money into another vigil?" Kandy Ferree, president and CEO of the National AIDS Fund, said that although she supports the quilt, she thinks its value in the AIDS community has diminished in part because it is so large and seldom seen in its entirety, the Times reports. Stop AIDS Project Executive Director Robert McMullin said that some people think that the quilt might have "lost its punch" over time. "The quilt is about loss," McMullin said, adding, "And while people are still dying, for most of us, the most important part of our message may not be about people dying." According to Jones, NAF has "taken it upon" itself to "decommission one of the most powerful weapons we have." He added that the quilt is not "intended as a passive memorial." The San Francisco Board of Supervisors earlier this month adopted a resolution that said it would be an "unconscionable and unthinkable offense against the citizenry of San Francisco" if portions of the quilt are not returned to the city, the Times reports. Some HIV/AIDS advocates also have suggested that the quilt be placed in a new San Francisco museum devoted to HIV/AIDS (New York Times, 1/31).
"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.