Generex Biotechnology's Subsidiary Antigen Express Initiates Clinical Trials In Patients With Her-2/neu Positive Breast Cancer
Generex Biotechnology Corporation announced today that patient enrollment had begun for trials with a novel therapeutic vaccine for breast cancer developed by its wholly owned subsidiary Antigen Express. The compound, AE37, is being tested with LTC George Peoples, MD, Medical Corps, U.S. Army at the Walter Reed Army Medical Center (WRAMC), in conjunction with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally mandated civilian-military collaboration between WRAMC, the Uniformed Services University of the Health Sciences (USU), the Windber Research Institute (Windber, PA) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation). The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment. Antigen Express entered into a Collaborative Research and Development Agreement (CRADA) last fall with the USU and the Foundation to work with Dr. Peoples to advance Antigen Express' HER-2/neu vaccine efforts for breast cancer.
The immunotherapy approach being evaluated in these trials has application not only to a variety of cancers but also to viral infections and autoimmune disease. The strategy is based upon proprietary Antigen Express technology designed to stimulate T helper cells in an antigen-specific manner. The importance of T helper cell stimulation in mounting an effective immune response has been demonstrated in a variety of laboratory models as well as in the clinic.
While the specific compound being used in these trials will be evaluated in patients with breast cancer, it is targeted to all tumors that overexpress the HER-2/neu oncogene. These include breast, ovarian, prostate, non-small- cell lung and colon cancer.
The immunological response to AE37 will be monitored throughout the course of treatment as well as for 1 year thereafter to explore the relationship between specific MHC class II alleles and immunological response. This will help to streamline future clinical trials and optimize selection of patients for treatment with AE37. Between 16 and 24 patients will be enrolled in this Phase I trial.
"The initiation of clinical trials is a milestone for Antigen Express," said Ms. Anna Gluskin, CEO of Generex. "We are please to see this important and novel form of immunotherapy advanced to the clinic and look forward to the results of this trial."
About Generex
Generex is engaged in the research and development of drug delivery systems and technology. To date, it has focused on developing a platform technology for the buccal delivery -- delivery to the oral cavity for absorption through the inner mouth mucosa -- of drugs that historically have been administered only by injection. Generex's buccal delivery technology has application to a large number of drugs. Generex acquired Antigen Express in August. 2003. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. 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 claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
CONTACT: Shayne Gilliatt of Generex Biotechnology Corporation,+1-800-391-6755, or +1-416-364-2551; or Ed Lewis of CEOcast, Inc.,+1-212-732-4300,
elewis@ceocast.com, for Generex Biotechnology Corporation
Web site:
http://www.generex.com/
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