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Generex Biotechnology Corporation (GNBT) Announces American Society of Clinical Oncology 2012 Podium Presentation Showcasing Antigen Express AE37 Cancer Vaccine Technology


6/8/2012 10:01:53 AM

WORCESTER, Mass. and TORONTO, June 6, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today a podium presentation on the technology and clinical results from the on-going Phase II clinical trial of the AE37 breast cancer vaccine being developed by Generex wholly-owned subsidiary Antigen Express, Inc. The presentation was at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (http://chicago2012.asco.org) on June 4, 2012 in Chicago, IL.

(Logo: http://photos.prnewswire.com/prnh/20110106/NY25057LOGO-b )

The abstract entitled "From bench to bedside: The use of the li-Key technology to improve helper peptides for clinical use in cancer vaccines" was presented during a session on Developmental Therapeutics Clinical Pharmacology and Immunotherapy. This abstract was recognized with a 2012 Conquer Cancer Foundation of ASCO Merit Award bestowed by the Conquer Cancer Foundation and the 2012 Scientific Program Committee. The merit award program was established to recognize high quality clinical and scientific advancements.

The presentation reviewed the significance of Ii-Key technology in cancer vaccine design and clinical trial data indicating that the AE37 breast cancer vaccine is safe, well tolerated and results in a significant increase in specific anti-HER2 response with minimal toxicity. With a median follow-up of 22 months in breast cancer patients, Kaplan Meier projections estimate recurrence rates of 10% in vaccinated patients versus 17% in the control group, a risk reduction of 41%. Of particular interest was the observation of a stronger reduction in relapse, from 31% in the control group to 11% in vaccinated patients (63% risk reduction), in patients with lower levels of HER2 expression. As these patients are not eligible for Herceptin therapy, they represent a significant area of unmet medical need.

A major obstacle in cancer immunotherapy is in educating the immune system to recognize tumor cells as foreign and destroying them as it does bacteria or viruses. While viruses can be inactivated and used themselves as a vaccine, tumor cells first require identification of appropriate tumor specific proteins (antigens) and then the technology to deliver those antigens such that the immune system recognizes them. Ii-Key technology fulfills this latter function. Advances in immunology have shown that specific activation of CD4+ T helper cells is critical for generating a robust and effective immune response. Modifying fragments of tumor specific proteins with Ii-Key dramatically improves their ability to activate CD4+ T helper cells to induce a specific and effective anti-cancer immune response.

"Results from the several clinical trials of AE37 provide convincing data validating the underlying Ii-Key technology as well as setting the stage for a Phase III trial of AE37," stated Dr. Eric von Hofe, PhD, President of Antigen Express. "We are gratified to see this platform technology recognized by our colleagues and prospective collaborators at the annual ASCO meeting."

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. 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. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Cautionary Note Regarding Forward-Looking Statements

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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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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