Generex Reports on Inaugural AE37 Breast Cancer Vaccine Scientific Advisory Board Meeting

WORCESTER, Mass. and TORONTO, June 8, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) reported today that the inaugural meeting of the Scientific Advisory Board (SAB) of its wholly-owned subsidiary, Antigen Express, Inc., for the company's AE37 breast cancer vaccine took place in Dallas, TX on May 19, 2012.

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The following distinguished scientists, scholars, and physicians joined representatives of Generex and Antigen Express at the SAB meeting:  Dr. Kathy D. Miller, MD (Indiana University School of Medicine Melvin and Bren Simon Cancer Center); Dr. Ian Krop, MD, PhD (Dana-Farber Cancer Institute, Harvard Medical School); Dr. James J. Mule, MD (Moffitt Cancer Centre); Dr. Keith L. Knutson, PhD (Mayo Clinic); Dr. Nuhad Ibrahim, MD (MD Anderson Cancer Center); Dr. Hope S. Rugo, MD (University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center); and, Dr. Samuel Jacobs, MD (National Surgical Adjuvant Breast and Bowel Project (NSABP).

Dr. Eric von Hofe, PhD, President of Antigen Express, reported:  "We had a successful and productive inaugural SAB meeting.  We are gratified that these key opinion leaders have recognized the potential of our AE37 breast cancer vaccine and joined with us to maximize the potential for clinical and regulatory success.  We have received invaluable input regarding our pending transition into a Phase III clinical trial of the vaccine."

Generex is also proud to announce that the following physicians have joined the SAB:

Dr. Samuel Jacobs, MD
Director, Medical Affairs
National Surgical Adjuvant Breast and Bowel Project (NSABP)

Dr. Samuel Jacobs, MD is an emeritus Clinical Professor in the Department of Medicine, University of Pittsburgh School of Medicine, and the Director of Medical Affairs for the National Surgical Adjuvant Breast and Bowel Project (NSABP).  Dr. Jacobs has a long and distinguished career as a clinical researcher in the fields of breast oncology and lymphoma.  His recent focus has been in area of developmental therapeutics. 

For the last four years, Dr. Jacobs has been intimately involved with the research efforts of the NSABP Foundation, Inc., which has more than 700 research sites in North America and an international network of oncology and research professionals.  The NSABP pioneered breast cancer studies that led to the establishment of lumpectomy plus radiation over mastectomy as the standard surgical treatment for breast cancer and was also the first group to demonstrate that adjuvant therapy (treatment in addition to surgery) could alter the natural history of breast cancer, increase survival rates, and prevent recurrence using chemotherapy as well as hormonal therapies.

In addition to his work in oncology treatment protocols, Dr. Jacobs has also conducted considerable research on the logistics and management of the clinical trial process in oncology.  He has led the efforts at the University of Pittsburgh Clinical Research Service to provide study development and implementation assistance, IRB processing, patient recruitment, study coordination, and specimen and data collection for all investigators conducting cancer-related studies at all UPMC Cancer Centers.

Dr. Jacobs received his MD from the University of Rochester, and has spent his career making the University of Pittsburgh Medical Center a leading institution in the field of oncology and cancer management.

With respect to his participation on the SAB, Dr. Jacobs states:  "Based on the exciting preliminary Phase II data on the AE37 vaccine in adjuvant treatment of breast cancer, it is possible that this vaccine will have a major impact on the future treatment of a subset of early breast cancer patients.  It seems clearly worthwhile to carefully determine its utility in a large well-conducted trial."

Dr. Jacobs will be in attendance at the company's End-of-Phase II meeting with the United States Food and Drug Administration (FDA) on June 18, 2012.

Dr. Gary H. Lyman, MD, MPH, FASCO, FRCP(Edin),
Duke University

Dr. Gary H. Lyman MD, MPH, FASCO, FRCP(Edin) is Professor of Medicine and Director of Comparative Effectiveness and Outcomes Research – Oncology at Duke University and the Duke Cancer Institute.  Dr. Lyman is also a Senior Fellow at the Duke Center for Clinical Health Policy Research.  Dr. Lyman received his undergraduate and medical degrees from the State University of New York in Buffalo and completed internal medicine residency at the University of North Carolina in Chapel Hill.  He subsequently completed a Clinical Hematology/Oncology Fellowship at the Roswell Park Memorial Institute and a Postdoctoral Fellowship in Biostatistics at the Harvard School of Public Health and the Dana Farber Cancer Center.

Dr. Lyman previously served as Professor of Medicine, Director of Medical Oncology and Chief of Medicine at the H Lee Moffitt Cancer Center and Research Institute.  During this period he served as Professor of Medicine and Professor of Epidemiology and Biostatistics as well as Associate Chairman of the Department of Medicine at the University of South Florida.  Prior to relocating to Duke University in 2007, Dr. Lyman held positions as Thomas Ordway Professor of Medicine and Cancer Center Director at the Albany Medical College and subsequently Professor of Medicine, Associate Cancer Center Director and Director of Health Services and Outcomes Research at the University of Rochester and Strong Memorial Hospital.

Dr. Lyman is Editor-In-Chief of Cancer Investigation and the Peer Review Editor for ASCO's Journal of Oncology Practice and on the Editorial Board of the Journal of Clinical Oncology and several other subspecialty journals.  In addition to serving as a Fellow of ASCO, Dr. Lyman is a Fellow of the Royal College of Physicians (Edinburgh), the American College of Physicians, the American College of Preventive Medicine and the American College of Clinical Pharmacology.  His research interests include personalized cancer supportive care, comparative effectiveness studies of targeted therapies and biomarkers, mathematical and statistical prognostic and predictive models, advanced methods of evidence synthesis in support of clinical practice guidelines and economic and cost-effectiveness studies of molecular diagnostics and novel targeted therapies.

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 focuses on modification of peptides with Ii-Key to increase potency while a second one 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