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Generex Enhances Antigen Express Scientific Advisory Board for the AE37 Breast Cancer Vaccine with Renowned Breast Cancer Researchers

WORCESTER, Mass. and TORONTO, May 15, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT), in anticipation of the transition into pivotal Phase III trials, is pleased to announce today that the expertise of the Scientific Advisory Board (SAB) of its wholly-owned subsidiary, Antigen Express, Inc., has been expanded by the addition of two globally recognized experts in clinical trial research and immuno-therapeutic treatments of breast cancer:

Dr. Kathy D. Miller, M.D.
Indiana University School of Medicine Melvin and Bren Simon Cancer Center
Department of Medicine, Division of Hematology and Oncology

Dr. Miller's career combines both laboratory and clinical research in breast cancer.  She has served as co-chair of the Hoosier Oncology Group Breast Committee since early 2002 and became co-chair of the Eastern Cooperative Oncology Group Breast Core Committee in 2010.  In these roles, she has worked with community oncologists to develop trials that combine clinical and biologic endpoints, yet remain feasible in non-academic settings.  Dr. Miller first honed her ability to coordinate multi-center trials as principal investigator for E2100, the first phase III trial to confirm the benefits of anti-angiogenic therapy in patients with metastatic breast cancer.  Dr. Miller currently leads E5103, an international phase III trial investigating anti-angiogenic therapy in the adjuvant setting.

Dr. Miller received her MD in 1991 from the Johns Hopkins School of Medicine in Baltimore, MD.  Dr. Miller completed internal medicine training at Hopkins, then returned to her native Midwest for fellowship training in hematology and oncology at Indiana University, serving as Chief Fellow in 1997.  She returned to Indiana University in 1999, attaining the rank of Associate Professor and Sheila D Ward Scholar in 2005.

Dr. Hope S. Rugo, M.D. 
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

Dr. Rugo is a Professor of Medicine in the Division of Hematology and Oncology at the University of California San Francisco (UCSF), where she directs Breast Oncology and Clinical Trials Education.  Her research interests include innovative new therapies for women with advanced breast cancer, evaluation of special circulating cells to help understand response to therapy, complementary medicine, and supportive care.

Dr. Rugo is a member of the breast core committee of the Alliance for Clinical Trials in Oncology Network, where she is the principal investigator of CALGB 40502, a now fully accrued phase III trial comparing novel chemotherapy agents in the treatment of advanced breast cancer.  She is also an investigator in the Bay Area Spore at UCSF's Carol Franc Buck Breast Cancer Center and the principal investigator of a number of clinical trials testing new treatment approaches.  Dr. Rugo is an investigator and novel agent chaperone for ISPY2, an innovative multicenter neoadjuvant chemotherapy trial.  She has published many peer-reviewed papers and has given presentations on a variety of cancer-related topics, and is the breast section editor for Cancer.Net, a patient focused publication of the American Society of Clinical Oncology.

With a summa cum laude undergraduate degree from Tufts University, Dr. Rugo received her M.D. from the University of Pennsylvania School of Medicine and completed both a residency in internal medicine and a fellowship in hematology and oncology at the UCSF.  Additionally, she completed a two-year post-doctoral fellowship in immunology at Stanford University.

Mark A. Fletcher, Generex President & Chief Executive Officer, commented:  "The Antigen Express Team is gratified that physicians and scientists of the caliber of Drs. Miller and Rugo have agreed to join our SAB and proffer invaluable advice and guidance as we now quickly move forward with our AE37 breast cancer vaccine clinical program, the lead therapeutic in Antigen Express' innovative Ii-key platform technology.  We look forward to availing ourselves of their considerable knowledge, experience, and expertise in the breast cancer field."

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 in immunotherapy. One of its platform technologies 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 or the Antigen Express website at

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
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