11/6/2006 GENEREX BIOTECHNOLOGY TO BEGIN THE FIRST HUMAN CLINICAL TRIAL OF AVIAN INFLUENZA VACCINE
Company signs agreement with the Lebanese-Canadian Hospital
in Beirut as a site for trials
November 6, 2006 – Generex Biotechnology Corporation (NasdaqCM:GNBT) announced today that it has entered into an agreement with the Lebanese-Canadian Hospital in Beirut, Lebanon to conduct a human clinical trial of the Antigen Express synthetic avian influenza vaccine, representing the first studies to be conducted in man. The study is being undertaken with the approval of the appropriate Lebanese governmental and regulatory bodies. Antigen Express, Inc., a wholly-owned subsidiary of Generex, designed the vaccine using its proprietary platform technology and has been conducting pre-clinical studies since 2004. Dr. Alexander Abdelnoor, Department of Microbiology & Immunology, Faculty of Medicine, American University of Beirut, will also be participating as a consultant for the trials.
The vaccine being developed by Antigen Express is based upon simple peptide-synthesis technology and can thus be manufactured rapidly, easily, and at inexpensive cost. This is in sharp contrast to traditional egg-based vaccines that rely on biological systems for vaccine production, making their availability to at-risk populations during a pandemic extremely limited. The preclinical studies conducted with the synthetic vaccine suggest that it may be used with more traditional vaccines to extend their utility as well as to prevent mortality associated with H5N1 infection when used alone.
The Antigen Express vaccine consists of specific fragments of the H5 protein from the H5N1 influenza virus that have been modified to enhance their potency in stimulating CD4+ T helper cells. Flu specific T helper cells have been shown to be essential in the development of a robust, protective immune response against influenza. The methods for enhancing the immune stimulating potency of the fragments were developed by Dr. Robert Humphreys, founder of Antigen Express. In brief, specific fragments of the H5 protein are identified (antigenic epitopes) that have the potential to interact with MHC class II molecules. The ability of CD4+ T helper cells to become stimulated to recognize specific proteins depends upon the presentation of epitopes derived from that protein to CD4+ cells by MHC class II molecules. Based upon an understanding of MHC class II charging by antigenic epitopes, Antigen Express scientists have developed proprietary methods for increasing the vaccine potency of antigenic peptides.
A similar synthetic peptide vaccine designed by the same methods targeting a tumor-associated protein (encoded by HER-2/neu) has been in the clinic for more than a year at the Walter Reed Army Medical Center (WRAMC). That compound has shown good activity in the antigen-specific stimulation of CD4+ T helper cells.
“The trials in Lebanon will complement nicely the studies planned for the US,” said Dr. Eric von Hofe, President of Antigen Express. “We know that bird flu is a threat that shows no signs of going away soon. Coupled with the lack of any widely available vaccine, it is paramount to begin testing the synthetic vaccine being developed at Antigen Express 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™ 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.
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Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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