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Generex Biotechnology Corporation (GNBT) Announces Establishment of a Scientific Advisory Board for Antigen Express, Inc. (GNBT)


5/10/2012 10:01:34 AM

WORCESTER, Mass. and TORONTO, May 9, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) announced today that a Scientific Advisory Board (SAB) has been established for its wholly-owned oncology immuno-therapeutics subsidiary, Antigen Express, Inc.

The function of the SAB is to provide advice and assistance to Antigen Express in respect of the clinical and regulatory programs for the Company's immuno-therapeutic cancer vaccines. The initial focus of the SAB will be to review the Phase II clinical trial of the Antigen Express AE37 breast cancer vaccine and facilitate the transition into a Phase III clinical trial.

The inaugural meeting of the SAB will take place in Dallas, TXMay 18 & 19, 2012.

Dr. Gabriel N. Hortobagyi, M.D., F.A.C.P.

Generex is pleased to announce that Dr. Gabriel N. Hortobagyi, M.D., F.A.C.P. has agreed to join the SAB.

Dr. Hortobagyi chairs the department of Breast Medical Oncology and directs the Breast Cancer Research Program at the University of Texas MD Anderson Cancer Center, where he also serves as Professor of Medicine and holds the Nellie B. Connally Chair in Breast Cancer.

Dr. Hortobagyi's research includes combination chemotherapy regimens, pre-surgical chemotherapy, and targeted therapies for all stages of breast cancer. He has contributed more than 900 articles to scientific journals, authored and co-authored 13 books, and contributed over 140 chapters to textbooks.

For his efforts in breast cancer research, Dr. Hortobagyi has received worldwide honors. In 2001, President Jacques Chirac named him Chevalier of the Order of la Legion d'Honneur de France. In 2003, Dr. Hortobagyi received the Glen Robbins Award in Breast Cancer Research from the New York Cancer Society and the Metropolitan Breast Cancer Group, and the Bristol-Myers Squibb 2003 Horizon Scientific Award. The Mexican Society of Oncology named him the 2005 World Leader in Oncology.

Dr. Hortobagyi was elected President of the American Society of Clinical Oncology (ASCO) for the 2006-2007 term; he serves on the Board of Directors of the Conquer Cancer Foundation. He served as President of the International Society of Senology and as a member of the Board of Governors of The International Association for Breast Cancer Research. He chairs the Breast Committee of the Southwest Oncology Group and for 20 years he chaired the Data and Safety Monitoring Committee of the National Surgical Adjuvant Breast and Bowel Project.

"Our goal here is to create a world-class collective of thought and opinion leaders in the breast cancer field," commented Mark A. Fletcher, Generex President & Chief Executive Officer. "Dr. Hortobagyi will proffer his vast experience and expertise to Antigen Express as we transition into a Phase III clinical trial of the AE37 breast cancer vaccine."

About AE37 and Ii-Key Hybrid Platform Technology

Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.

The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.

About Breast Cancer

According to the American Cancer Society, more than 232,000 women will be diagnosed with breast cancer, and nearly 40,000 will die from the disease, in 2012. For women whose cancer tests positive for increased quantities of the HER2, approved targeted therapies include trastuzumab (Herceptin®; Roche-Genentech). However, only 25% of breast cancer patients have HER2 levels high enough to be eligible for Herceptin. AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER2 expression.

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 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


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