Rockville, MD—The United States Military Cancer Institute (USMCI) and Generex Biotechnology Corporation announced that they have entered into a Phase II clinical trial for a novel peptide vaccine for breast cancer. The immunotherapeutic vaccine, AE37, is being developed by Generex's Antigen Express subsidiary in the U.S. The study will be conducted in conjunction with USMCI's Clinical Trials Group.
The trial will be a randomized, multi-center study among 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. The endpoint for the study will be a 50 percent reduction in rate of relapse of the disease at the two-year point. USMCI and Generex initiated a Phase I trial of AE37in April 2005, the results of which showed good immunostimulatory activity, safety and tolerance.
AE37 is being tested under the direction of Colonel George Peoples, M.D., at Brooke Army Medical Center. The study is a collaboration among USMCI, the Uniformed Services University of the Health Sciences (USU) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF). Antigen Express entered into a Clinical Trial Agreement with HJF to enable work with Peoples, USMCI and USU, with the goal of advancing the company's HER-2/neu vaccine efforts for breast cancer.
The immunotherapeutic agent being developed by Antigen Express is a peptide derived from a tumor-associated protein that has been modified to enhance the 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 tumors from a variety of cancers, including breast, ovarian, prostate, lung, colon, stomach and pancreatic cancers. Antigen-specific stimulation of T helper cells, which occurs after immunization with AE37, has been shown in prior studies to be critical for the immune system to mount an effective anti-tumor response.
USMCI, a USU program, is a tri-service initiative that coordinates and supports multi-institutional cancer research within the DoD system. The Institute has many initiatives under way, including a new BioSpecimen Network and a Tissue Microarray Core facility. When the new Walter Reed National Military Medical Center opens in 2011, it will serve as the USMCI Clinical Research Cancer Center, and as the focal point for cancer research in the military. USMCI operates with Congressional funding and is a collaborative effort among Walter Reed Army Medical Center, the National Naval Medical Center, the Armed Forces Institute of Pathology and HJF.
USU (www.usuhs.edu) is a fully accredited federal school of medicine and graduate school of nursing. The University is recognized worldwide as a preeminent center for the study of military and emergency medicine, preventive medicine, tropical diseases, disaster medicine and adaptation to extreme environments.
HJF (www.hjf.org) is a private, not-for-profit organization chartered by Congress to support military medical research and education at USU and throughout military medicine. HJF's technology transfer staff encourages scientists and private industry to collaborate on research and development projects, with the goal of making innovative medical technologies available for clinical use.
Generex (www.generex.com) is engaged in the research and development of drug delivery systems and technologies. Antigen Express (www.antigenexpress.com) is a wholly owned subsidiary of Generex, and the company's core platform technologies comprise immunotherapeutics for the treatment of malignant, infectious, allergic and autoimmune diseases.