Generex Makes Podium Presentation of Vaccine Technology Platform With Cancer & Influenza Updates at PepTalk 2010

Company Plans Additional Studies and Regulatory Submissions


WORCESTER, Mass., Jan. 19, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) announced today the presentation of the immuno-therapeutics vaccine technology platform and product pipeline of its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The podium presentation, entitled “Immunotherapy Using Ii-Key Modified Peptides for Increased, Antigen-Specific T Helper Cell Activation,” was made by Antigen Express President Dr. Eric von Hofe at the Cambridge Healthtech Institutes’ ninth annual PepTalk Conference held in San Diego January 11 – 15, 2010. The symposium highlighted advances in the field of peptide therapeutics and was attended by leaders in academia, industry and regulatory agencies.

Anna Gluskin, Generex’s President and Chief Executive Officer, stated that: “We are very encouraged by the interim results from the immunotherapeutic vaccine studies and, as a result, we intend to move forward with additional studies, including a Phase III breast cancer vaccine study and a Phase II prostate cancer vaccine study, and regulatory submissions.” 

Antigen Express is developing ‘next generation’ immunotherapeutic peptides for the treatment of cancer, infectious diseases, and other serious illnesses. The Antigen Express proprietary modification employed in the design of peptides dramatically improves the antigen-specific stimulatory activity of the peptides and consequently their use as both immunotherapeutic and prophylactic vaccines. The Company recently disclosed interim results of a randomized Phase II study of its lead compound, AE37, showing no relapses in the AE37 group compared to a 7% relapse rate in the control arm after 13 months. Based on these positive results, a Phase III study of AE37 in breast cancer patients and a Phase II study in prostate cancer patients are planned.

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™ device.  The Company's flagship product, oral insulin (Generex Oral-lyn™), 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.

The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831

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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