Generex Biotechnology Corp. (fka GNBTQ)

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Generex Biotechnology Announces Presentation of Early Results Showing Activity of Cancer Vaccine in Patients with Triple Negative Breast Cancer
PR NewswirePress Release: Generex Biotechnology Corporation – 10 minutes ago
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Generex Biotechnology Corp.

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WORCESTER, Mass. and TORONTO, Sept. 13, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (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.

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