GENEREX, U.S. MILITARY INITIATE TRIAL OF BREAST CANCER VACCINE

Generex Biotechnology has begun a Phase II clinical trial using its novel peptide vaccine in breast cancer patients in conjunction with the U.S. Military Cancer Institute's Clinical Trials Group under a clinical trial agreement. The immunotherapeutic vaccine, AE37, is being developed by Generex's Antigen Express division.

The Phase II study will be a randomized, multicenter trial in patients who have completed standard therapy for node-positive or high-risk node-negative breast cancer expressing at least low levels of the HER-2/neu oncogene. These patients are at an increased risk for recurrence; therefore, the endpoint for this study will be a 50 percent reduction in the rate of relapse of disease at two years.

The immunotherapeutic agent being developed by Antigen Express is a peptide derived from a tumor-associated protein that has been modified to enhance stimulation of CD4-positive T helper cells. The target protein is encoded by the HER-2/neu oncogene, which has been found to be over-expressed in a variety of tumors including breast, ovarian, prostate, lung, colon, stomach and pancreas, according to the company. Antigen-specific stimulation of T helper cells, as occurs after immunization with AE37, has been shown in prior studies to be critical for the immune system to mount an effective antitumor response.