Generex Oncology Awarded Two IRS Therapeutic Discovery Project Grants

WORCESTER, Mass., Nov. 10, 2010 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board: GNBT) announced today that its wholly-owned immunotherapeutics subsidiary, Antigen Express, Inc. (www.antigenexpress.com), has been awarded two Therapeutic Discovery Project grants, totaling $488,958.50, by the United States Internal Revenue Service (IRS) and the Department of Health and Human Services (HHS) pursuant to the Patient Protection and Affordable Care Act of 2010.

The Antigen Express Therapeutic Discovery Projects are entitled:

• Ii-Key Her-2/neu Peptide Vaccine, for the treatment of breast cancer
• Ii-Key Her-2/neu Peptide Vaccine, for the treatment of prostate cancer

The proprietary vaccine being developed by Antigen Express is an off-the-shelf product designed to reduce the risk of relapse in cancer patients.  It is the subject of a controlled, randomized Phase II trial in patients with breast cancer which has yielded positive interim results.  Based on positive results from a Phase I trial in prostate cancer patients, preparations for a Phase II clinical trial in prostate cancer patients are underway.  In all studies, the self-potentiating vaccine has shown very low toxicity and generates a good immune response.  

The Therapeutic Discovery Project grants are targeted for projects that show a reasonable potential to: result in new therapies to treat areas of unmet medical need or prevent, detect, or treat chronic or acute diseases and conditions; reduce the long-term growth of health care costs in the United States; or, significantly advance the goal of curing cancer within 30 years.  Grant allocations also take into consideration which projects show the greatest potential to create and sustain high-quality, high-paying U.S. jobs, and to advance U.S. competitiveness in life, biological, and medical sciences. 

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 buccal insulin spray product, Generex Oral-lyn™, 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 immunotherapeutic vaccines 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency.  Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

SOURCE Generex Biotechnology Corporation

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