WORCESTER, Mass., Sept. 2, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation () (Nasdaq:GNBT) today announced the engagement of Dr. George E. Peoples, Jr., M.D., F.A.C.S. as a consultant to the Company in respect of the on-going clinical and regulatory work of Antigen Express, Inc. (), the Company's wholly-owned subsidiary, in respect of the proprietary Antigen Express AE37 immunotherapeutic breast cancer vaccine, presently in a Phase II clinical trial at The Henry M. Jackson Foundation for the Advancement of Military Medicine ().
Dr. Peoples is presently the Chief of Surgical Oncology at Brooke Army Medical Center in Houston, TX, a Professor of Surgery and the Director & Principal Investigator of the Cancer Vaccine Development Program at Uniformed Services University of the Health Sciences in Bethesda, MD, and the Deputy Director of the United States Military Cancer Institute (). Dr. Peoples is a graduate of Johns Hopkins University School of Medicine.
During his career, Dr. Peoples has authored over 100 papers in peer-reviewed journals and conducted numerous clinical studies of peptide vaccines. As such, he is uniquely qualified to help guide the success of AE37. Pursuant to the consultancy arrangement, Dr. Peoples will supervise the on-going Phase II clinical trial of the Company's breast cancer vaccine, provide advice and assistance to the Company in respect of the design and implementation of a Phase III trial of the vaccine, and liaise with the Food and Drug Administration regarding the clinical and regulatory development of the vaccine. "We are very fortunate to have the assistance of Dr. Peoples in the development of AE37," said Dr. Eric von Hofe, President of Antigen Express. "There are few people with his experience and insight into the development of active immunotherapy for cancer."
In addition to the ongoing Phase II trial of AE37 in breast cancer patients, a trial of AE37 in patients with prostate cancer has been completed recently and a third trial testing the combination of AE37 with an additional immunotherapeutic agent is ongoing. The Company has been encouraged by positive interim results from the Phase II breast cancer trial, released toward the end of 2009, as well as the overall positive outlook for active immunotherapeutics.
"The Antigen Express AE37 breast cancer vaccine is an exciting and promising product," commented Dr. Peoples. "I very much welcome the opportunity to work with Generex Oncology to bring this important innovation to market."
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. The Company's flagship product, buccal insulin (Generex Oral-lyn™), which has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at or the Antigen Express website at .
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Safe Harbor Statement
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," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
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