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Generex Initiates Clinical Trials in Patients With Her-2-Neu Positive Breast CancerBreast cancer news 3/23/2005 Generex Biotechnology Corporation announced the initiation of enrollment in to their new clinical trial a novel therapeutic vaccine for breast cancer developed by its wholly owned subsidiary Antigen Express. This compound is known as AE37, and is being tested with LTC George Peoples, MD, Medical Corps, U.S. Army at the Walter Reed Army Medical Center (WRAMC), in conjunction with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally mandated civilian-military collaboration between WRAMC, the Uniformed Services University of the Health Sciences (USU), the Windber Research Institute (Windber, PA) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation). Antigen Express entered into a Collaborative Research and Development Agreement (CRADA) last fall with the USU and the Foundation to work with Dr. Peoples to advance Antigen Express' HER-2/neu vaccine efforts for breast cancer. This immunotherapy approach that is being evaluated in these trials has wider scope and application than breast cancer. In addition to breast cancer and other cancers it also is expected to reveal more information on viral infections and autoimmune disease. The strategy is based upon proprietary Antigen Express technology designed to stimulate T helper cells in an antigen-specific manner. The importance of T helper cell stimulation in mounting an effective immune response has been demonstrated in a variety of laboratory models as well as in the clinic. While the specific compound being used in these trials will be evaluated only in patients with breast cancer, the vaccine is targeted to all tumors that overexpress the HER-2/neu oncogene. These include breast, ovarian, prostate, non-small- cell lung and colon cancer. The immunological response to AE37 will be monitored throughout the course of treatment as well as for 1 year thereafter to explore the relationship between specific MHC class II alleles and immunological response. This will help to streamline future clinical trials and optimize selection of patients for treatment with AE37. Between 16 and 24 patients will be enrolled in this Phase I trial. "The initiation of clinical trials is a milestone for Antigen Express," said Ms. Anna Gluskin, CEO of Generex. "We are please to see this important and novel form of immunotherapy advanced to the clinic and look forward to the results of this trial." For more information on this clinical trial contact : Shayne Gilliatt of Generex Biotechnology Corporation,1-800-391-6755, or 1-416-364-2551; or Ed Lewis of CEOcast, Inc. 1-212-732-4300, elewis@ceocast.com, for Generex Biotechnology Corporation Web site: http://www.generex.com/ |