WORCESTER, Mass. and TORONTO, June 6, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today a podium presentation on the technology and clinical results from the on-going Phase II clinical trial of the AE37 breast cancer vaccine being developed by Generex wholly-owned subsidiary Antigen Express, Inc. The presentation was at the Annual Meeting of the American Society of Clinical Oncology (ASCO) ( http://chicago2012.asco.org) on June 4, 2012 in Chicago, IL.
The abstract entitled " From bench to bedside: The use of the li-Key technology to improve helper peptides for clinical use in cancer vaccines" was presented during a session on Developmental Therapeutics – Clinical Pharmacology and Immunotherapy. This abstract was recognized with a 2012 Conquer Cancer Foundation of ASCO Merit Award bestowed by the Conquer Cancer Foundation and the 2012 Scientific Program Committee. The merit award program was established to recognize high quality clinical and scientific advancements.
The presentation reviewed the significance of Ii-Key technology in cancer vaccine design and clinical trial data indicating that the AE37 breast cancer vaccine is safe, well tolerated and results in a significant increase in specific anti-HER2 response with minimal toxicity. With a median follow-up of 22 months in breast cancer patients, Kaplan Meier projections estimate recurrence rates of 10% in vaccinated patients versus 17% in the control group, a risk reduction of 41%. Of particular interest was the observation of a stronger reduction in relapse, from 31% in the control group to 11% in vaccinated patients (63% risk reduction), in patients with lower levels of HER2 expression. As these patients are not eligible for Herceptin therapy, they represent a significant area of unmet medical need.A major obstacle in cancer immunotherapy is in educating the immune system to recognize tumor cells as foreign and destroying them as it does bacteria or viruses. While viruses can be inactivated and used themselves as a vaccine, tumor cells first require identification of appropriate tumor specific proteins (antigens) and then the technology to deliver those antigens such that the immune system recognizes them. Ii-Key technology fulfills this latter function. Advances in immunology have shown that specific activation of CD4+ T helper cells is critical for generating a robust and effective immune response. Modifying fragments of tumor specific proteins with Ii-Key dramatically improves their ability to activate CD4+ T helper cells to induce a specific and effective anti-cancer immune response.