SOURCE: Generex Biotechnology

October 27, 2005 12:15 ET

Generex Biotechnology Presents Proposal to Interested U.S. Senators to Accelerate Development of Novel Pandemic Avian Influenza Vaccine

Company Seeks Congressional Support to Expedite Development of Its Avian Flu Vaccine

TORONTO -- (MARKET WIRE) -- October 27, 2005 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that senior representatives of the Company, together with executives of Antigen Express, Inc., its wholly owned immunotherapeutics subsidiary, presented a proposal today to interested senior senators to seek support for the accelerated development of its novel vaccine for H5N1 avian influenza.

The Company believes that the novel vaccine being developed at Antigen Express will be a valuable asset in combating avian influenza. The vaccine being developed is based on a proprietary platform technology whereby protein fragments (epitopes) from a novel antigen are identified and modified to enhance T helper cell stimulation. Activation of T helper cells has been shown to be essential in establishing an acquired immune response and in immunological memory. These features are particularly important in mounting an effective response to the potentially pandemic H5 strain of avian influenza.

"We believe we have made excellent progress in developing a novel vaccine to counter a pandemic avian influenza," said Anna Gluskin, President & Chief Executive Officer of Generex. "Our proprietary platform technology has been used to develop other immunotherapeutic vaccines that are currently in clinical trials, and we believe that the ease of manufacturing these vaccines and the urgent need to provide immunization merits congressional support for our activities. We are encouraged by the initial response to our proposal from these senior senators to help us in accelerating the development of our influenza vaccine."

Since the Antigen Express compound is a peptide, it can be manufactured easily and relatively inexpensively in any of a variety of existing manufacturing plants in large amounts. A serious limitation on most other proposed vaccines for H5 avian influenza is the inability to manufacture large quantities.

Antigen Express is developing other immunotherapeutic vaccines for cancer and infectious diseases using its proprietary technology platform enhancing T helper cell stimulation. The nature of the platform is such that any novel infectious agent can be analyzed rapidly for identification of MHC class II epitopes and subsequent modification for increased potency in stimulating T helper cells in an antigen-specific fashion.

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; or

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