SOURCE: Generex Biotechnology Corporation

February 05, 2007 07:25 ET

Volunteers Selected for Human Clinical Trial of Generex Biotechnology's Synthetic Avian Influenza Vaccine

TORONTO -- (MARKET WIRE) -- February 5, 2007 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that 50 volunteers have been selected and final preparations made for initiation of human clinical trials of the synthetic avian influenza vaccine under development by its wholly owned subsidiary, Antigen Express, Inc. The Company previously entered into an agreement with the Lebanese-Canadian Hospital in Beirut, Lebanon to conduct the Phase I trial. An additional 70 prospective volunteers are presently being screened by the Hospital. An aggregate of 160 patients are expected to participate in the trial.

Antigen Express has pioneered the development of a novel peptide vaccine technology for both therapeutic and prophylactic purposes. The technology has particular advantages for use against the potentially pandemic H5N1 avian influenza virus in that a peptide vaccine could be made in much larger amounts, more rapidly, and less expensively than the more traditional egg-based vaccine. Currently, it would be possible to vaccinate only a small fraction of the US population, let alone the world, using the traditional egg-based vaccine in the event of a pandemic.

The technology being developed by Antigen Express entails modification of a small fragment of the hemagglutinin protein from the H5N1 virus to more potently stimulate CD4+ T helper cells. The antigen-specific stimulation of T helper cells has been shown to be crucial in establishing immunity to foreign agents. This type of T helper stimulation is expected to augment the activity, and hence number of people, that could be immunized with a traditional egg-based vaccine as well as to protect against the lethality of the H5N1 virus when used alone.

Antigen Express-modified vaccine peptides have been developed for a variety of indications and shown good activity both in preclinical and clinical studies. The most advanced of these is a peptide designed to elicit an immunological response against the HER-2/neu oncoprotein which is expressed by breast cancer cells as well as by a variety other types of cancer cells. That peptide, in clinical trials since April of 2005, has been shown to be safe, well-tolerated and produced the desired antigen-specific stimulation of T helper cells in breast cancer patients.

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 (Generex Oral-lyn™), which is available for 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 website at www.generex.com or the Antigen Express website at www.antigenexpress.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 cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Contact Information

  • For more information, please contact:

    For Generex:
    Shayne Gilliatt
    Generex
    800-391-6755 or 416-364-2551

    Andrew Hellman
    CEOcast, Inc.
    212-732-4300

    Michael Smith
    Rubenstein Public Relations
    212-843-1900
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