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
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