Generex Presents New Positive AE37 Phase II Breast Cancer Vaccine Data

Dec 06, 2010, 08:00 ET from Generex Biotechnology Corporation

WORCESTER, Mass., Dec. 6, 2010 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board: GNBT) today announced two presentations of data obtained from its on-going Phase II trial of its novel immunotherapeutic AE37 vaccine in breast cancer patients.  The presentations, entitled Combination Immunotherapy:  Safety and Immunologic Data from a Phase II Trial Administering a HER2/neu-derived Peptide Vaccine Sequentially or Concurrently with Trastuzumab and Increased prevalence of HLA-DR3 among breast cancer patients: implications for adjuvant HER2/neu peptide vaccine trials, will be made at the 33rd Annual San Antonio Breast Cancer Symposium (www.sabcs.org) in San Antonio, Texas from December 8-12, 2010.  

The presentation on combination immunotherapy reports that patients receiving both AE37 and Trastuzumab (Herceptin®), a monoclonal antibody targeting the same protein, have increased specific immune-stimulation of T cells when AE37 is given simultaneous to administration of Trastuzumab rather than following Trastuzumab treatment.  These results confirm prior published reports suggesting that the combination of Trastuzumab with active immunotherapy can work synergistically in cancer patients.

The second presentation reports that patients who are genetically predisposed to less efficiently recognize peptides derived from the HER2 protein have an immunological response to the AE37 HER2 peptide vaccine that is similar in robustness to the response in patients not having this predisposition.  This is promising confirmation that AE37, which is designed as a self-potentiating peptide vaccine, indeed has improved activity that may be clinically relevant.

The 2010 CTRC-AACR San Antonio Breast Cancer Symposium, an international scientific symposium for interaction and exchange among scientists and clinicians in breast cancer, is presented by Cancer Therapy & Research Center at UT Health Science Center San Antonio, the American Association for Cancer Research, and Baylor College of Medicine.  The driving force behind this collaboration is the shared mission of the organizations to advance progress against breast cancer.  By combining their respective strengths, the San Antonio Breast Cancer Symposium encompasses the full spectrum of breast cancer research and facilitates the rapid transition of new knowledge into improved care for breast cancer patients.

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 buccal insulin spray product, 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 immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases.  For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

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 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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