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Generex Biotechnology to Present Pandemic Influenza Vaccine Program at Bird Flu Summit in Washington, D.C.

Posted on: Monday, 27 February 2006, 09:00 CST

Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Dr. Douglas Powell, Ph.D., Director of Immunobiology of Antigen Express, Inc., the Company's wholly owned subsidiary, will make a presentation at an international conference on the Antigen Express program for the development of a novel synthetic peptide vaccine designed to protect against the potentially pandemic avian influenza virus.

The international Bird Flu Summit will take place in Washington, D.C. from February 27 - 28, 2006. The purpose of the summit is to bring greater transparency to the global effort to fight the flu, provide an exchange network among the summit participants, and improve the quality of communication, coordination, and collaboration needed for an international response program. Facilities will be available for sponsorship, exhibition, media interviews, and contract conferences.

The vaccine design strategy being developed by Antigen Express employs small portions of a protein from the pathogenic agent, in this case portions of the H5 protein, and modifying them for maximal stimulation of the immune systems' T helper cells. These cells play a critical role in directing a variety of immune responses against pathogenic agents as well as in preserving immunological memory. The advantage of using small fragments of proteins is that they can be manufactured by synthetic means in existing facilities. This means that very large amounts of the vaccine can be made relatively rapidly and at lower cost. Currently, neither the traditional egg-based method nor the cell culture based method for production of H5N1 vaccines can supply quantities sufficient for vaccinating more than a fraction of the U.S. population because of limitations on manufacturing capacity.

Antigen Express has pioneered the development of antigen-specific peptide vaccines for stimulation of T helper cells. The work of the founder of Antigen Express, Dr. Robert Humphreys, showed how the activity of antigenic peptides could be greatly enhanced by addition of a small portion of the MHC class II associated Ii protein (termed Ii-Key). This increased potential for antigen-specific T helper stimulation has been demonstrated in a variety of cell culture systems as well as animal models. Interim results from an ongoing clinical trial of an Ii-Key-modified peptide vaccine from Antigen Express designed for HER-2/neu positive cancers are encouraging. That peptide, though derived form the HER-2/neu protein, was designed by methods similar to those being used with portions of the H5 protein.

"We are very pleased with the progress that has been made at Antigen Express in developing a synthetic vaccine to combat avian influenza," said Anna Gluskin, President and Chief Executive Officer of Generex. "There is clearly an urgent need for this type of vaccine and we are advancing it to the clinic as rapidly as possible."

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. 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: Shayne Gilliatt Generex Biotechnology Corporation Phone: (800)391-6755 and (416)364-2551  Ed Lewis CEOcast, Inc. Phone: 1 (212)732-4300  

SOURCE: Generex Biotechnology

Source: MARKET WIRE

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