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.
Dr. 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.
"We are excited and committed to move the AE37 cancer vaccine through the appropriate scientific and regulatory steps," commented Mark Fletcher, President & Chief Executive Officer of Generex. "AE37 not only continues to move closer to market approval but also provides validation for the underlying Ii-Key technology platform upon which it is based."
Phase I studies clearly identified the potential for AE37 to induce the immune system to focus on the HER2 protein through helper (CD4) and cytotoxic (CD8) immune cells in patients. The HER2 protein is expressed on a high percentage of cancers in the breast, prostate, ovaries, gastro-intestinal tract, and lung. In two Phase I trials, AE37 has demonstrated a good safety profile in both breast and prostate cancer patients.
The AE37 cancer vaccine has also completed a Phase 1 trial in prostate cancer demonstrating appropriate dosing and immune activation similar to that seen in the breast cancer trials. The Phase 2b breast trial results add to AE37's database on tolerability and safety and have raised the possibility of using AE37 early in prostate cancer therapy. With the Phase 2b breast cancer trial suggesting immune activation by AE37 could control breast cancer and seeing similar immune activation in the Phase I prostate trial, the Company is encouraged to move AE37 cancer vaccine more rapidly into larger clinical trials in men with newly diagnosed HER2 positive prostate cancer. These Phase 2 trials are being designed with leading oncologists in prostate cancer.
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