Generex Announces Publication of Pre-Clinical Studies Demonstrating Utility of Its Vaccine Platform for Addressing Pandemic Influenza


WORCESTER, Mass., Aug. 5, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) today announced publication of pre-clinical studies conducted to identify vaccine peptides for the potentially pandemic H5N1 avian influenza virus. The report is the result of a collaboration between scientists at Antigen Express, Inc. (www.antigenexpress.com), Generex's wholly-owned immunotherapeutics subsidiary, and Dr. John Treanor (Professor of Medicine, and of Microbiology and Immunology, Department of Medicine, University of Rochester).

The study, entitled: "Identification of HLA class II H5N1 hemagglutinin epitopes following subvirion influenza A (H5N1) vaccination," appears in the journal Vaccine. Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It serves as an interface between academics, those in research and development, and workers in the field. Relevant topics range from basic research through to applications, safety and legislation. Peer-reviewed articles containing primary, original observations as well as reviews appear in the journal.

The Antigen Express study utilizes its proprietary Ii-Key technology as well as a broad screening technique to identify fragments of the H5N1 avian influenza virus with the potential to act as vaccine peptides. Specifically, T cells from the peripheral blood of volunteers who received the traditional egg-based H5N1 vaccine and developed a documented immune response were used for these studies. As a measure of peptide potency, cytokine release by T cells in response to challenge with individual peptides was measured. The results of these studies are helpful in guiding and optimizing synthetic peptide vaccines for pandemic or potentially pandemic influenza viruses, a platform being pioneered by Antigen Express.

The advantage of the synthetic peptide vaccine platform is that vaccines can be made more rapidly, in larger amounts and at inexpensive cost relative to egg- or cell-based manufacturing methods. Antigen Express technology focuses on antigen-specific stimulation of T helper cells. This cell type has been shown to be crucial in developing a robust immune response to a novel pathogenic agent.

Over 120 volunteers have been immunized with Antigen Express's proprietary vaccine peptides as part of a Phase I trial to generate a response against the H5N1 avian influenza. The vaccine peptides appear to be safe and well tolerated. In addition to the H5N1 trial, immunotherapeutic peptides designed by the same Antigen Express technology are being tested in a Phase II efficacy trial in breast cancer patients and a Phase I trial in patients with breast or ovarian cancer. A Phase I trial of an Antigen Express vaccine has been completed recently in patients with prostate cancer.

About Generex Biotechnology Corporation

Generex is engaged in the research, development and commercialization 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 (Generex Oral-lyn(tm)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. 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 in respect of 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 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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