Generex Announces Interview Of MD Anderson's Dr. Elizabeth Mittendorf, Principal Investigator On Company's AE37 Phase IIb Breast Cancer Efficacy Trial
WORCESTER, Mass. and TORONTO, June 12, 2013 /PRNewswire/ -- Generex Biotechnology Corporation ( www.generex.com) (OTCBB:GNBT) today announced an interview given by Dr. Elizabeth Mittendorf, M.D., Ph.D. Dr. Mittendorf is the Principal Investigator of the Company's AE37 clinical trial to test the ability of the novel immunotherapeutic agent to prevent relapse in patients who have had HER2-expressing breast cancer, the largest Phase IIb peptide clinical trial conducted to date. AE37 is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. ( www.antigenexpress.com). The interview was conducted by Oncology TV at this year's Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago from May 31 to June 4. The interview can be viewed online at:
The interview of Dr. Mittendorf, Assistant Professor, Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, gave an overview of this year's ASCO presentations on AE37, as well as where the breast cancer vaccine fits into the field of cancer immunotherapy. She noted that cancer immunotherapy in general was much more in the limelight at this year's conference. She described the two distinguishing features of AE37 that set it apart from other types of cancer vaccines. Firstly, the vaccine is designed to stimulate CD4+ T helper cells, which are key in generating a more robust anti-tumor immune response. Secondly, the vaccine includes a proprietary modification that increases its potency. The studies that were part of this year's ASCO meeting confirm these unique properties. Dr. Mittendorf was also noted that this vaccine addresses patients with any level of HER2 expression, unlike other HER2-targeted therapies. Currently, patients with low HER2 expression represent a patient population of significant unmet need (representing 50% of all breast cancers).
The updates this year built upon interim results of the Company's controlled, randomized Phase IIb clinical trial of AE37 presented at last year's ASCO meeting. Those presentations demonstrated a clear trend toward reduced relapse in breast cancer patients who had received AE37. One of the studies this year showed that while some patients developed a hypersensitivity reaction (urticarial response), they appeared to have a stronger all-around immune response to the AE37 vaccine. Interestingly, no relapses have been observed in this population of patients. A second presentation demonstrated that repeated AE37 boosters could be safely given to patients to further augment and extend the initial anti-tumor immune response observed with AE37.
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