![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » GENEREX, U.S. MILITARY INITIATE TRIAL OF BREAST CANCER VACCINE
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.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
11Jul
-
18Jul
-
21Oct