SOURCE: Generex Biotechnology

November 09, 2005 09:10 ET

Generex Biotechnology Proposes Collaborations in China for the Co-Development of a Novel Vaccine for Pandemic Avian Influenza

Peptide-Based Vaccine Offers Easy Scale-Up and Flexibility in Preparing for Possible Pandemic Bird Flu Threat

TORONTO -- (MARKET WIRE) -- November 9, 2005 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, has made proposals for co-development of the Antigen Express novel H5N1 avian influenza vaccine in China following a trip to Beijing by Dr. Minzhen Xu, the Antigen Express Vice-President of Biology.

Proposals were made to: Professor Hualan Chen of the Harbin Veterinary Research Institute; Ms. Nan Wang, Vice General Manager of Sinovac Biotech Co., Ltd.; and Professor Bing Sun of the Institute of Biochemistry and Cell Biology, Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences. All have an interest in vaccine development for the H5N1 avian influenza in China.

The vaccine technology being employed at Antigen Express for the potentially pandemic avian influenza is the same as that for its novel immunotherapeutic cancer vaccine currently in clinical trials. "The basis of this technology lies in identifying portions of a specific disease-associated protein that are capable of stimulating T-helper cells which are subsequently modified to augment their vaccine potency," explained Dr. Xu. "T-helper cells play a critical role in generating an immune response to a novel foreign agent, directing other immune cells against that threat, and in establishing immunological 'memory' of that agent. Once these cells are stimulated, it is much easier to mount an effective response against an agent such as the H5N1 influenza virus."

Antigen Express has extant collaborations in China focusing on SARS and a novel immunotherapy strategy for patients with acute myeloid leukemia. "These relationships provide a convenient platform for expanding into avian influenza in China," said Dr. Eric von Hofe, President of Antigen Express. "The danger posed by avian influenza in China is more acute, given the recent outbreaks of the H5N1 strain in birds there, and they face the same supply limitations on traditional vaccines as are faced throughout the world. Furthermore, vaccinating people close to hot spots of H5N1 outbreaks is recognized as the best way to control a possible pandemic." Current estimates are that the world capacity per year for production of H5N1 vaccine by traditional methods would protect less than 40 million people.

Scientists at Antigen Express are developing a vaccine for the potentially pandemic Asian bird flu utilizing highly conserved fragments of the H5 protein to stimulate potent T-helper cell activity. The H5 fragments are modified using a portion of an immunoregulatory protein (termed Ii-Key) that greatly facilitates their ability to stimulate T-helper cell responses specific to the H5N1 strain. The vaccine peptides have been selected for their likelihood of being both potent and active in more than 90% of the population. This technology has the advantage of being applicable to any novel agent or protein once one has sequence information. As vaccine peptides are manufactured by entirely synthetic means they can be produced rapidly, relatively inexpensively, and in large quantities (hundreds of millions of 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™ 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 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," "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.

Contact Information

  • Shayne Gilliatt
    Generex Biotechnology Corporation
    1-800-391-6755
    +1-416-364-2551

    Ed Lewis
    CEOcast, Inc. for Generex Biotechnology Corporation
    +1-212-732-4300
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