GNBT News
Generex Management Provides Update to Stockholders
2012-09-20 09:30 ET - News Release
WORCESTER, Mass. and TORONTO , Sept. 20, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) ( www.generex.com ) today released the following letter to its stockholders. The purpose of this letter is to provide the Generex Biotechnology Corporation stockholders with an update on Company initiatives and a review of Company operations over the past year. (a) Antigen Express The clinical and regulatory program for the Antigen Express, Inc. ( www.antigenexpress.com ) proprietary AE37 immunotherapeutic breast cancer vaccine continues and we have made significant strides over the last twelve months. Presentations of encouraging interim data from the on-going Phase II clinical trial of the vaccine at the San Antonio Breast Cancer Symposium, the Annual Meeting of the American Society of Clinical Oncology (ASCO), and the recent ASCO Breast Cancer Symposium were well received. Earlier this year, we established a Scientific Advisory Board (SAB) consisting of globally acknowledged key thought and opinion leaders in the treatment of breast cancer to provide us with advice, guidance, and assistance on the further development of AE37. With input from the United States Food and Drug Administration (FDA) and the SAB, we have refined the End-of-Phase II package in respect of the vaccine and will submit the package to the FDA prior to an End-of-Phase II meeting with the FDA. We expect to submit our request for an End-of-Phase II meeting to the FDA before the end of September. In preparation for a Phase III trial, we will develop a Special Protocol Assessment (SPA) to demonstrate the efficacy of AE37 in breast cancer patients with low HER2 expression, a patient population roughly twice the size of the high HER2 expression population and representing a significant unmet need as they are ineligible for treatment with Herceptin. Antigen Express is in the midst of active discussions with prospective industry collaborators for the Phase III trial. Note that the Antigen Express proprietary immunotherapeutic vaccines technology is a "platform" technology that can be used for a variety of other cancers as well as other therapeutic areas such as infectious diseases (influenza) and immune-metabolic disease (diabetes). Antigen Express and its future collaborations will leverage the success of the breast cancer vaccine to create additional products.
