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news.Generex Biotechnology has submitted an investigational new drug application to the FDA for its AE37 immunotherapeutic vaccine combined with a vaccine peptide that works by a different mechanism for patients.
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The new Phase I clinical trial will examine the safety and immunological response of breast and ovarian cancer patients to a combination of AE37 plus a peptide vaccine designed to stimulate cytotoxic T lymphocytes.
Currently, AE37 is the subject of a Phase II study in patients with breast cancer under an IND by George Peoples at the Brooke Army Medical Center as well as a Phase I study in prostate cancer patients conducted by Aristides Karagiannis and Costas Baxevanis at the Euroclinic in Athens, Greece. The additional Phase I clinical trial in breast and ovarian cancer will be funded by Mary Crowley Medical Research Centers.
AE37 is a novel peptide vaccine that is the product of a proprietary technology platform established at Antigen Express designed to increase the antigen-specific stimulation of CD4+ T helper cells. The immunotherapeutic cancer vaccine AE37 is being developed through Antigen Express, the wholly owned immunotherapeutics subsidiary of Generex.