Generex Biotechnology's Subsidiary Antigen Express Initiates Clinical Trials in Patients with Her-2/neu Positive Breast Cancer

24-Mar-2005

Generex Biotechnology Corporation announced that patient enrollment had begun for trials with a novel therapeutic vaccine for breast cancer developed by its wholly owned subsidiary Antigen Express. The compound, AE37, 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). The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment. 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.

The immunotherapy approach being evaluated in these trials has application not only to a variety of cancers but also to 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 in patients with breast cancer, it 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.

https://www.bionity.com/en/news/44634/generex-biotechnology-s-subsidiary-antigen-express-initiates-clinical-trials-in-patients-with-her-2-neu-positive-breast-cancer.html