Generex Biotechnology Corporation has entered into a phase II clinical trials using its novel peptide vaccine in breast cancer patients in conjunction with the United States Military Cancer Institute's (USMCI) Clinical Trials Group under a Clinical Trial Agreement. Tthe immunotherapeutic vaccine, AE37, is being developed by Generex's Antigen Express division in the United States.

The phase II study will be a randomized, multi-centre 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% reduction in the rate of relapse of disease at two years. The trial was designed to take advantage of changing paradigms (not yet adopted) for the study of therapeutic cancer vaccines, which proposes a two-phase rather than a three-phase clinical investigation strategy.

The parties initiated a Phase I trial of AE37 were initiated in April of 2005 and have shown good immunostimulatory activity while being safe and well tolerated.

The immunotherapeutic agent being developed by Antigen Express is a peptide derived from a tumour-associated protein that has been modified to enhance stimulation of CD4+ 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 tumours including breast, ovarian, prostate, lung, colon, stomach and pancreas. 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 anti-tumour response.

AE37 is being tested under the direction of COL George Peoples, MD, Medical Corps, U.S. Army stationed at Brooke Army Medical Center. The study involves a collaboration with the USMCI, the Uniformed Services University of the Health Sciences (USU) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation). Antigen Express has entered into a Clinical Trial Agreement with the Foundation to work with Dr. Peoples, USMCI, and USU to advance Antigen Express' HER-2/neu vaccine efforts for breast cancer.

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).