SOURCE: Generex Biotechnology

November 04, 2005 10:30 ET

Generex Scientist Presents Results of Pandemic Influenza Vaccine Program at Washington Conference Highlighting Strategic Advances in Vaccines

Novel Vaccine Technology Boosts T Helper Cell Responses to Asian Bird Flu Influenza

TORONTO -- (MARKET WIRE) -- November 4, 2005 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that the Chief Scientific Officer of Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, made a presentation earlier today at a national conference regarding the Company's program for accelerated development of its novel vaccine for pandemic influenza.

Dr. Robert Humphreys, M.D., Ph.D., the Chief Scientific Officer of Antigen Express, presented results of an ongoing, prioritized program to develop a novel approach to vaccinating against pandemic influenza at the Third Annual Conference on Vaccines in Washington, D.C. Many leaders in vaccine development in the U.S. government, industry, and academic centers are attending the conference.

Dr. Humphreys has spent his career understanding how antigenic peptides are presented to the immune system and how novel treatments for disease might be designed. As a research fellow at Harvard University, he first isolated the MHC class II molecules, which present antigenic peptides to T helper cells to regulate the immune response. Subsequently, as Professor of Pharmacology and Medicine at the University of Massachusetts Medical School, Dr. Humphreys discovered the immunoregulatory Ii protein that binds naturally into the antigenic peptide-binding site of those MHC class II molecules. He showed that a segment of the Ii protein, the Ii-Key peptide, acts on MHC class II molecules to regulate peptide binding or exchange. More recently, he and his colleagues at Antigen Express have discovered and patented novel hybrid peptides in which the immunoregulatory Ii-Key peptide is linked covalently to antigenic epitopes. Many papers from Antigen Express scientists and collaborators demonstrate the potential of such vaccine peptides.

The practical result of these discoveries is to provide a very flexible and rapid means for developing peptide vaccines that stimulate T helper cells. Once a target protein is identified, straightforward methods are available for predicting those fragments with the greatest potential to stimulate T helper cells, linking them to Ii-Key for maximized potency and running biological screening assays to identify lead candidates. In addition to this technology base, the Company has advanced specific product candidates for infectious diseases and cancer towards the clinic. The most advanced of these is an Ii-Key hybrid of a peptide found in the cancer-associated HER-2/neu protein. This compound is currently in Phase I clinical trials at the Walter Reed Army Medical Center. Under the leadership of Dr. Eric von Hofe, President of Antigen Express, Generex has organized its forces to speed development of a novel vaccine to protect against the H5N1 avian influenza.

A major drawback to current vaccine development efforts is the inability to manufacture enough vaccine in the event of an avian flu pandemic. Current estimates are that the total production capacity of the world for producing an avian flu vaccine using traditional methods is less than 40 million doses, at the cost of several 100 million dollars. A compounding problem in developing vaccines for the avian flu is that two doses are required to achieve protective immunity given that people have never been exposed to a flu virus similar enough to impart even partial immunological protection.

The great advantage of the Antigen Express vaccine is the ability to expand and strengthen the T helper cell response. T helper cell stimulation is pivotal in developing an effective immune response to novel agents. In addition to increasing the overall response to a lower dose of classically produced vaccine, it is also expected that the vaccine hybrids will afford some significant degree of protection in people who have received no other vaccine. The Ii-Key/H5 hybrids can be synthesized inexpensively and in large quantities.

Anna Gluskin, President & Chief Executive Officer of Generex Biotechnology said: "I thank all of my colleagues at Antigen Express for their outstanding effort in advancing this vaccine toward clinical trials. The theoretical reasons why these special vaccine hybrid peptides might be very effective as a stand-alone as well as in allowing lower doses of recombinant H5 protein to be used are well established in many peer-reviewed papers. Data from their H5 preclinical studies are beginning to bear this out. We plan, as fast as possible, to bring these novel compounds to protect against pandemic influenza into the clinic."

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™ device. The Company's flagship product, oral insulin (Oral-lyn™), 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. Antigen Express is a wholly owned subsidiary of Generex. 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

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," "forecasts," "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. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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