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WORCESTER, Mass. and
Jan. 3, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) today provided an update to the clinical development & regulatory strategy for its cancer vaccine, AE37. Positive interim Phase 2b clinical data from the study in HER-2 expressing breast cancer subjects (presented last month at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in
San Antonio, Texas) has lead to an earlier-than-expected advancement in the overall development of AE37 for both breast and prostate cancer indications.
AE37 is a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine designed to train the immune system, independent of HLA-type, to track down cancer cells throughout the body and destroy them. The positive interim Phase 2b results, building upon completed pre-clinical and Phase I breast cancer studies, enables Antigen Express to move up the timing of key development and regulatory plans. In particular, the company will organize an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by the end of Q1 2012. With the FDA's guidance, the Company will move into a pivotal Phase 3 clinical development program in women with loco-regional breast cancer that express low to moderate levels of HER2. Parallel steps will be taken with the European Medicines Agency using the same Phase 2b results. The Phase 2b is currently planned to enroll a total of 300 women and will continue as planned to provide additional valuable information on efficacy and safety of AE37 as the Company pursues its Phase 3 trial plans.
Eric von Hofe, Ph.D., President of Antigen Express, said: "While the number of patients with recurrent breast cancer is still too low to confirm statistical significance in this ongoing study, the approximate 46% reduction in breast cancer recurrence in low HER2 expressing tumors together with excellent safety enables us to move forward in requesting an End-of-Phase II meeting with the FDA."
Importantly, the majority of women with loco-regional breast cancer have low to moderate expressing HER2 tumors and currently are treated with chemotherapy and radiotherapy only. There is no approved targeted HER2 therapy for these women.