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Generex Announces Presentations of Antigen Express AE37 Breast Cancer Vaccine Data at ASCO 2012


Abstract scheduled for podium presentation also the subject of a 2012 Conquer Cancer Foundation of ASCO Merit Award

WORCESTER, Mass. and TORONTO, May 8, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today that abstracts featuring the AE37 breast cancer vaccine clinical program of Generex wholly-owned subsidiary Antigen Express, Inc. will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (http://chicago2012.asco.org) taking place June 1-5, 2012 in Chicago, IL.

An abstract entitled "From bench to bedside: The use of the li-Key technology to improve helper peptides for clinical use in cancer vaccines" will be the subject of an oral presentation on Monday, June 4, 2012 at 5:30 pm CDT during the 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 of the American Society of Clinical Oncology and the 2012 Scientific Program Committee. The merit award program was established to recognize high quality abstracts.

An abstract entitled "An assessment of disease features and immune response in breast cancer patients that did not recur after receiving HER2 peptide, AE37 vaccine in a randomized phase II trial" will be the subject of a poster presentation on Saturday, June 2, 2012 from 8 am – 12 pm CDT.

"The inclusion of these abstracts in this year's ASCO annual meeting is a reflection of both the quality and the maturity of the Antigen Express AE37 breast cancer vaccine clinical program," stated Mark Fletcher, Generex President & Chief Executive Officer. "We look forward to updating the oncology community on our progress." In December 2011 the Company announced positive interim results of the ongoing Phase II clinical trial of the vaccine. The Company has previously announced its intention to organize an End-of-Phase II meeting with the U.S. Food & Drug Administration (FDA) and move into pivotal Phase III trials.

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 in immunotherapy. One of its platform technologies 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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