Antigen Express Initiates Trials in Her-2/neu Positive Breast Cancer
Generex Biotechnology has 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 the U.S. Army at the Walter Reed Army Medical Center in conjunction with the Clinical Breast Care Project.
Antigen Express' 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 one year thereafter to explore the relationship between specific MHC Class II alleles and immunological response. This evaluation 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.