Generex Biotechnology Working on Vaccine Development Against Bioterror Agents

Main Category: Bio-terrorism / Terrorism
Article Date: 11 Feb 2005 - 6:00 PDT

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Collaborates to Use Animal Models and Volunteer Samples to Test Activity Of Novel Smallpox Vaccine -

Generex Biotechnology Corporation (Nasdaq: GNBT) announced today that its wholly owned subsidiary, Antigen Express, has established collaborations with Emory University and the Imperial College of London to develop a novel smallpox vaccine. The vaccine is based on proprietary Antigen Express technology employing modified peptide antigens to stimulate immunity. The collaboration brings together one of the pre-eminent investigators on vaccinia, Dr. Geoffrey Smith of the Imperial College, and the noted immunologist Dr. Rafi Ahmed of Emory University. Dr. Robert Humphreys, founder of Antigen Express, will coordinate the program at Antigen Express.

Antigen Express has developed proprietary technologies that dramatically enhance the immunogenicity of small fragments from viral or tumor-associated proteins. "This is a particularly attractive strategy in the case of bioterror agents such as smallpox," said Robert Humphreys, founder and Chief Scientific Officer of Antigen Express. "The manufacture of small peptides is trivial compared to whole virus and safety concerns are virtually negligible.

We are excited and fortunate to be able to work with such distinguished individuals as Drs. Geoffrey Smith and Rafi Ahmed on this project."

The specter of a smallpox bioterror attack has pointed to the need for a safer smallpox vaccine. The frequency of adverse reactions to the existing vaccinia virus used for vaccination against smallpox is high enough as to prevent mass vaccinations. While attempts have been made at generating safer vaccines, none have been developed that are thought to be safe enough today for widespread use. Dr. Geoffrey Smith of the Imperial College of London has studied extensively the immunological responses to vaccinia and is a recognized leader in this field. His investigations have been instrumental both in identifying the key proteins to use as vaccines as well as model systems wherein to characterized potential vaccines.

Dr. Rafi Ahmed has a long-standing interest in the ability of the immune system to 'remember' prior exposures to an infectious agent and respond appropriately to subsequent infections, focusing both on HIV and vaccinia.

This is of particular interest in the context of Antigen Express technologies for stimulation of T helper cells, which have long been shown to play a key role in immunological memory and are critical in mounting a robust response. Antigen Express has demonstrated the potential of this technology in preclinical models and plans to begin clinical trials in patients with breast cancer during the first quarter of this year.

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)), is in late stage clinical trials around the world. Generex acquired Antigen Express in August. 2003. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

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.

Generex Biotechnology Corporation
http://www.generex.com

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