WORCESTER, Mass. and TORONTO, June 7, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) announced today that an End-of-Phase II meeting has been scheduled with the United States Food and Drug Administration (FDA) in respect of the Phase II clinical trial of the AE37 breast cancer vaccine being undertaken by its wholly-owned subsidiary, Antigen Express, Inc.
The meeting has been scheduled for June 18, 2012 with FDA regulatory management staff in the Office of Cellular Tissues and Gene Therapies in the Center for Biologics Evaluation and Research. Antigen Express has provided the FDA with a comprehensive and detailed package regarding the AE37 breast cancer vaccine, the on-going Phase II clinical trial, and the company's plans for a transition into a pivotal Phase III trial.
Antigen Express will solicit guidance from the FDA regarding the company's proposed structure of a pivotal Phase III trial.
In addition to representatives of Antigen Express, Dr. Samuel Jacobs, MD, Director, Medical Affairs, National Surgical Adjuvant Breast and Bowel Project (NSABP) and a member of the Antigen Express AE37 breast cancer Scientific Advisory Board (SAB), will attend the meeting to proffer his advice and assistance on behalf of Antigen Express. The NSABP is a clinical trials cooperative group supported since its inception by the National Cancer Institute (NCI). It has a more than 50-year history of designing and conducting clinical trials that have changed the way breast cancer is treated, and, more recently, prevented. The NSABP was the first to demonstrate that adjuvant therapy could alter the natural history of breast cancer. Since its inception, the NSABP has enrolled more than 110,000 women and men in clinical trials in breast and colorectal cancer. It has research sites at nearly 1000 major medical centers, university hospitals, large oncology practice groups, and health maintenance organizations in the United States, Canada, Puerto Rico, Australia, and Ireland. At those sites and their satellites, more than 5000 physicians, nurses, and other medical professionals conduct NSABP treatment and prevention trials.In addition to Dr. Jacobs, another member of the SAB, an oncologist specializing in comparative effectiveness studies of targeted therapies and biomarkers, mathematical and statistical prognostic and predictive models, and advanced methods of evidence synthesis in support of clinical practice guidelines, will attend the meeting.