Press Release: Generex Biotechnology to Initiate Phase II Clinical Trial in Breast Cancer Patients
Generex Biotechnology to Initiate Phase II Clinical Trial in Breast Cancer Patients in Collaboration With United States Military's Cancer Institute Positive Phase I Results Lead to Randomized Phase II Efficacy Studies TORONTO-- Feb 1, 2007 -- Generex Biotechnology Corporation announced today that it has entered into a Phase II clinical trial using its novel peptide vaccine in breast cancer patients in conjunction with the United States Military Cancer Institute's (USMCI) Clinical Trials Group under a Clinical Trial Agreement. The immunotherapeutic vaccine, AE37, is being developed by Generex's Antigen Express division in the United States. The Phase II study will be a randomized, multi-center trial in patients who have completed standard therapy for node-positive or high-risk node-negative breast cancer expressing at least low levels of the HER-2/neu oncogene. These patients are at an increased risk for recurrence; therefore, the endpoint for this study will be a 50% reduction in the rate of relapse of disease at two years. The trial was designed to take advantage of changing paradigms (not yet adopted) for the study of therapeutic cancer vaccines, which proposes a two-phase rather than a three-phase clinical investigation strategy. The parties initiated a Phase I trial of AE37 were initiated in April of 2005 and have shown good immunostimulatory activity while being safe and well tolerated. The immunotherapeutic agent being developed by Antigen Express is a peptide derived from a tumor-associated protein that has been modified to enhance stimulation of CD4+ T helper cells. The target protein is encoded by the HER-2/neu oncogene, which has been found to be over-expressed in a variety of tumors including breast, ovarian, prostate, lung, colon, stomach and pancreas. Antigen-specific stimulation of T helper cells, as occurs after immunization with AE37, has been shown in prior studies to be critical for the immune system to mount an effective anti-tumor response. AE37 is being tested under the direction of COL George Peoples, MD, Medical Corps, U.S. Army stationed at Brooke Army Medical Center. The study involves a collaboration with the USMCI, the Uniformed Services University of the Health Sciences (USU) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation). Antigen Express has entered into a Clinical Trial Agreement with the Foundation to work with Dr. Peoples, USMCI, and USU to advance Antigen Express' HER-2/neu vaccine efforts for breast cancer. About Generex Generex is engaged in the research and development 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 Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express 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. Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning 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 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.