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Generex Subsidiary Antigen Express Provides Update on AE37 Cancer Vaccine's Clinical & Regulatory Strategy
Date:1/3/2012

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 onc
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SOURCE Generex Biotechnology Corporation
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