Generex Announces Publication of Abstract at ASCO 2012 Showing Potential of Antigen Express AE37 Immunotherapeutic Cancer Vaccine Technology in Prostate Cancer

WORCESTER, Mass. and TORONTO, June 14, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) announced today publication of an abstract demonstrating a more broad and robust immunological response in AE37 treated patients with prostate cancer than previously suspected.  The AE37 immunotherapeutic cancer vaccine, currently in Phase II clinical trials in patients with breast cancer, is being developed by Generex wholly-owned subsidiary Antigen Express, Inc.. The abstract is published in conjunction with the Annual Meeting of the American Society of Clinical Oncology (ASCO) as part of the Journal of Clinical Oncology (J Clin Oncol 30, 2012 (suppl; abstr e15125).

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The abstract, entitled "Effect of immunization with the Ii-Key modified HER2/neu(776-790) (AE37) peptide vaccine on pre-existent immunity to PSA in HLA-A24+ prostate cancer patients: Association with increased AE37-specific immunologic responses", examines the immunological response to PSA in patients who had received AE37 in a Phase I trial of AE37 in prostate cancer patients. While AE37 induces an immune response to the HER2 cancer-associated protein, the investigators reasoned that this response might serve to amplify immunological responses to other cancer related proteins occurring in the patient.

The study showed that eight patients in a clinical trial of AE37 had a preexistent immune response to the prostate-specific antigen (PSA). After receiving the AE37 vaccine, it was observed that patients not only had an augmented HER2 immunological response but surprisingly had a stronger response to PSA as well. This finding argues that many cancer patients may have existing immune responses against their cancer but that it is simply ineffective. Inducing a response to one cancer related antigen may help to tip the balance between tumor cell tolerance and tumor cell eradication in favor of eradication.

The AE37 immunotherapeutic cancer vaccine has been shown to generate a robust immunological response against HER2 in both breast and prostate cancer patients while a recent interim analysis has suggested a reduction in relapse in breast cancer patients receiving the vaccine in a controlled randomized trial. AE37 stimulates different types of immune cells (T cells) to specifically attack HER2 expressing cancer cells. A distinguishing feature of the vaccine is that it designed on a technology platform that more effectively delivers the vaccine to immune cells.

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 technology 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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