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.
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
SOURCE Generex Biotechnology Corporation