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Generex Announces Interview of MD Anderson's Dr. Elizabeth Mittendorf, Principal Investigator on Company's AE37 Phase IIb Breast Cancer Efficacy Trial
Date:6/12/2013

lares the design, clinical endpoints, and statistical analyses acceptable for FDA approval.

Finally, Dr. Mittendorf pointed to the possible real benefit of combining AE37 with other agents, such as immune checkpoint inhibitors.  In particular, inhibitors of PD-1 (programmed cell death protein 1) or CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) have been shown to essentially take the brakes off the immune system, allowing it to more effectively combat tumor cells in a general way.  As AE37 activates the immune system to specifically attack tumor cells, essentially "stepping on the gas", it is an exciting hypothesis to try combining them.  It should be noted, however, that patients treated with AE37 alone also appear to have "taken the brakes off" the immune system to an extent.

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 p
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