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news.Generex Biotechnology has entered into a phase II trial, using its peptide vaccine in breast cancer patients, in conjunction with the US Military Cancer Institute's Clinical Trials Group.
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The immunotherapeutic vaccine, AE37, is being developed by Generex' Antigen Express division in the US.
The phase II study will enroll 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 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+ 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.
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-tumor response.