GNBT,
Clinical Trial Results From Cancer Vaccine Being Developed by Generex Biotechnology Subsidiary to Be Presented at San Antonio Breast Cancer Symposium
Thursday December 14, 7:15 am ET
TORONTO--(MARKET WIRE)--Dec 14, 2006 -- Generex Biotechnology Corporation (NASDAQ:GNBT - News) announced today that the results of clinical studies on a novel cancer vaccine being developed by its wholly owned immunotherapeutics subsidiary, Antigen Express, Inc., will be presented at the 29th Annual San Antonio Breast Cancer Symposium (www.sabcs.org), December 14 - 17, 2006. The results of the studies will be presented by COL George Peoples, MD, a collaborator of Antigen Express who has been directing the trials at the Walter Reed Army Medical Center.
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The presentation is entitled "Results of a phase I clinical trial of an Ii-Key/Her2/neu MHC class II peptide-based vaccine in breast cancer patients" and reports clinical data from the Phase I clinical trial of the Antigen Express cancer vaccine being conducted at the Walter Reed Army Medical Center in Washington, D.C. The clinical studies were initiated in April of 2005.
The immunotherapeutic vaccine being developed at Antigen Express, AE37, is designed to elicit a specific response against a protein encoded by the HER-2/neu oncogene, which is expressed in a high percentage of various types of cancer. The trials have shown that the vaccine is safe, well-tolerated and produces a significant immune response in breast cancer patients. While the target of AE37 is the same as that of the marketed cancer drug Herceptin, the activity of AE37 relies on its ability to stimulate a patient's own immune system to recognize the cancer target rather than by interacting with the target directly. The advantage of this is that the immune system, once activated, is capable of detecting lower levels of the target protein than is Herceptin and that the anti-tumor activity lasts long after termination of AE37 treatment.
"The Phase I studies have been successful both in establishing the safety of AE37 as well as in determining an optimal biological dose," said Dr. Eric von Hofe, President of Antigen Express. "The results of these studies provide a solid foundation both for subsequent Phase II studies designed to look at the efficacy AE37 and for upcoming clinical trials on the use of AE37 in prostate cancer patients."
The San Antonio Breast Cancer Symposium (SABCS) is a division of the Cancer Therapy & Research Center (CTRC). CTRC is an independent, non-profit institution committed to providing the highest quality cancer treatment, research, and education. The objective of the SABCS is to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease to an international audience of academic and private physicians and researchers. The scientific program consists of invited lectures and mini-symposia by experts in clinical and basic research, selected slide and poster presentations, and case discussions. This international symposium is directed primarily towards academic and private physicians and researchers involved in breast cancer in medical, surgical, gynecologic, and radiation oncology, as well as other appropriate health care professionals.
About Generex
Generex is engaged in the research and development 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(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com. |
