WORCESTER, Mass., March 3, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) announced today that the first patient has received its immunotherapeutic AE37 vaccine as part of a new combination therapy approach for breast and ovarian cancer patients. This vaccine therapy is designed to activate immune cells that can detect and destroy cancer cells. AE37 is being developed by the Company's wholly-owned immunotherapeutics subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The new Phase I clinical trial, being performed at the Mary Crowley Cancer Research Centers ("Mary Crowley") in Dallas and the Brooke Army Medical Center ("BAMC") in San Antonio, will assess safety and immunological response in patients with either breast and/ or ovarian cancer. Patients in the study will be clinically cancer free, having completed primary standard of care breast and/or ovarian therapies.
The Generex vaccine being used in this study, AE37, is designed to increase immune response. This design specifically increases the ability of CD4+ T helper cells to recognize HER-2/neu expressing cancer cells in immunized patients, which should prompt the immune system to mount a robust anti-cancer response. The cancers of all patients in these trials express some level of HER-2/neu. An advantage of using this type of active immunotherapy, as opposed to passive immunotherapy such as treatment with Herceptin, is that activated immune cells can detect and destroy cancer cells expressing much lower levels of HER-2/neu than is needed for recognition by Herceptin.
The Company's AE37 vaccine is currently the subject of a Phase II investigation in patients with breast cancer as well as a Phase I trial in prostate cancer patients. The Phase II study is being conducted by Dr. George Peoples of BAMC while the Phase I prostate cancer study is being conducted by Drs. Karagiannis and Baxevanis at the Euroclinic in Athens, Greece. The results of a Phase I study of AE37 in breast cancer patients were recently published in the Journal of Clinical Oncology (vol. 26, pages 3426-3433, 2008). The immunotherapeutic vaccine was found to be safe, well-tolerated, and produced the desired immunological response.
In this new trial, AE37 will be paired with a second HER-2/neu-derived peptide designed to stimulate a different portion of the immune system. The trial results will determine both safety and immunological response. Mary Crowley investigators Dr. John Nemunaitis and Dr. Neil Senzer helped design the clinical study as part of a collaboration between Dr. George Peoples at BAMC, Mary Crowley and Antigen Express.
"We are very excited to be initiating this new Phase I trial," commented Dr. Eric von Hofe, President of Antigen Express. "The trial represents a significant expansion in the clinical development of the AE37 immunotherapeutic cancer vaccine."
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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India 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 www.generex.com or the Antigen Express website at www.antigenexpress.com.
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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.