Generex Biotechnology Begins Research Collaboration on Novel Allergy Therapy With Major European Company
Stallergenes, a Principal European Allergy Firm Near Paris, Tests Novel Approach to Immunotherapy of Allergy and Asthma Designed by Antigen Express Generex Biotechnology Corporation (Nasdaq: GNBT - News) today announced that a Research Collaboration Agreement has been signed by its subsidiary Antigen Express, Inc. with Stallergenes, S.A. a major European firm in immunological treatments for allergy and asthma. The studies are to design and test Ii-Key/allergen epitope hybrid peptides to create a novel approach for the control of both dangerous forms of asthma and functionally disabling allergic reactions. A large number of individuals in both North America and Europe suffer from various forms of allergic responses. These range from allergic rhinitis to cat dander, to ragweed hayfever, to potentially fatal asthmatic attacks from bee sting or peanut allergens. Antigen Express scientists have discovered that a segment of the immunoregulatory protein called Ii, acts on the HLA-DR molecules, which present antigenic peptide epitopes of allergens to T regulatory lymphocytes. By coupling this Ii-Key peptide covalently to the antigenic epitope peptides, the potency of the HLA-DR presented epitope is increased about 200 times in cell culture experiments and about 8 to 10 times after injecting animals. Allergists have been seeking a method to stimulate T helper cells in a manner that directs the immune response away from the allergic pattern. Allergy symptoms arise when a T helper cell type 2 (TH2) response occurs to an environmental antigen, stimulating production of immunoglobulin E (IgE). When IgE is crosslinked by recognition of an allergen protein, on the surface of mast cells and basophils, histamine and other mediators of allergy are released. A wide range of responses can be found ranging from local redness and swelling in the skin, itchy nose, ears, roof of mouth, watery eyes and sneezing, to severe bronchoconstriction requiring powerful medicines and potentially intubation and respiratory support. Antigen Express scientists have found that their established approach to stimulating responses to cancer and infectious disease antigens stimulates a strong TH1 response, away from a TH2 response. That is exactly the pattern sought in research studies to tune down allergic reactions. This method of treatment goes directly to the cause of the allergic response, rather than just treatment of symptoms. "Since my days in the Allergy Clinic of the Bethesda Naval Hospital, trying to help patients with moderate to severe forms of allergy and asthma, I have followed the scientific and clinical literature toward making some better product," said Robert Humphreys, M.D., Ph.D., the Chief Scientific Officer of Antigen Express. He feels now that he might just have that better product to control allergic reactions. Nevertheless, "A lot of work lies ahead, in collaboration with skilled researchers and clinicians working in allergy." In collaboration with Dr. Philippe Moingeon, Director of Research and Development at Stallergenes, Dr. Humphreys has designed a series of Ii-Key/allergic epitope hybrid peptides for assays in France, using both lymphocytes from allergic patients and in mouse animal models. Dr. Moingeon said, "Bob Humphreys has developed a novel approach to controlling allergy. We seek to test it further in the laboratory, to see if basic biological mechanisms support further work toward clinical trials. Potential advantages lie in the use of peptide fragments of the allergen, not recognized by IgE, and in the enhanced potency of the epitope so that therapy can be at very small doses." About Generex Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral- lyn (TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Generex acquired Antigen Express in August, 2003. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex Web site at http://www.generex.com. Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "f orecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward- looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. 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