Generex Biotechnology Announces Publication of Novel Immunotherapeutic Cancer Vaccine Results in Patients With Prostate Cancer

Generex Biotechnology Announces Publication of Novel Immunotherapeutic Cancer Vaccine Results in Patients With Prostate Cancer

WORCESTER, Mass., May 18, 2010 (GlobeNewswire via COMTEX News Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT) announced today publication of results from the first Phase I study of its lead immunotherapeutic agent AE37 in patients with prostate cancer. At the end of 2009, the Company announced positive interim results from a Phase II trial being conducted with AE37 in patients with breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc.

The report, entitled, "Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer," is being published (online publication date = May 13, 2010) in the journal Clinical Cancer Research, a journal of the American Association for Cancer Research whose focus is to publish innovative clinical and translational cancer research studies that bridge the laboratory and the clinic. The study extends previous observations demonstrating safety and immunological activity of AE37 in cancer patients. Interestingly, a decrease in the circulating levels of a fragment of the HER-2/neu protein was also observed in immunized patients. These results warrant a Phase II clinical study to establish the efficacy of AE37 in prostate cancer patients.

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, buccal insulin (Generex Oral-lyn(TM)), which has been approved 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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: Generex Biotechnology Corp.

CONTACT:  American Capital Ventures, Inc.
Investor Relations Contact:
Howard Gostfrand
1-877-918-0774
Beckerman Public Relations
Media Contact:
Angelene Taccini
201-488-0049

(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.

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