Generex Biotechnology Announces Presentation of Early Results Showing Activity of Cancer Vaccine in Patients with Triple Negative Breast Cancer

WORCESTER, Mass. and TORONTO, Sept. 13, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) (www.generex.com), announced today presentation of early results from an efficacy study of an immunotherapeutic in triple negative breast cancer patients.  The immunotherapeutic is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly owned subsidiary of Generex.  The results will be presented on Friday, September 14, 2012 at the 2012 Breast Cancer Symposium organized by the American Society of Clinical Oncology (ASCO) being held in San Francisco September 13 - 15.

The presentation, entitled Early Efficacy Analysis of the AE37 Vaccine in Patients with HER2 Low-Expressing and Triple Negative Breast Cancer, will be made by Dr. Elizabeth Mittendorf, who is the Principal Investigator of the ongoing Phase II trial of the immunotherapeutic AE37.  While the study showed an overall reduction of 42% in the risk of relapse in all patients of the study who received the vaccine, the reduction in the risk of relapse was 66% in patients with low expression of the HER2 oncoprotein who were classified as having triple negative breast cancer.

The immunotherapeutic being developed by Antigen Express is designed to generate an immune response specifically targeting tumor cells expressing the HER2 oncoprotein.  While this is the same target as that of the widely used drug Herceptin, the immune response elicited by AE37 is capable destroying cells expressing lower levels of HER2 that are required for sensitivity to Herceptin.  "The suggestion of the ability of AE37 to prevent recurrence in breast cancer patients is very encouraging," said Dr. Mittendorf.  "This is particularly so in patients with triple negative disease, for whom treatment options are extremely limited," she added.

Antigen Express is currently in late stage Phase II clinical development of AE37.  Based upon positive data obtained to date, the company is proceeding with plans for a pivotal Phase III trial.

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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