Generex Biotechnology Corporation (Nasdaq:GNBT) announced today publication of results from the first Phase I study of its lead immunotherapeutic agent AE37 in patients with prostate cancer. At the end of 2009, the Company announced positive interim results from a Phase II trial being conducted with AE37 in patients with breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc.
The report, entitled, "Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer," is being published (online publication date = May 13, 2010) in the journal Clinical Cancer Research, a journal of the American Association for Cancer Research whose focus is to publish innovative clinical and translational cancer research studies that bridge the laboratory and the clinic. The study extends previous observations demonstrating safety and immunological activity of AE37 in cancer patients. Interestingly, a decrease in the circulating levels of a fragment of the HER-2/neu protein was also observed in immunized patients. These results warrant a Phase II clinical study to establish the efficacy of AE37 in prostate cancer patients.
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