9/28/2004 GENEREX BIOTECHNOLOGY ESTABLISHES CRADA WITH THE UNIFORMED SERVICES UNIVERSITY AND THE HENRY M. JACKSON FOUNDATION FOR NOVEL HER-2/NEU VACCINE STUDIES AND CLINICAL TRIALS AT WALTER REED ARMY MEDICAL CENTER IN PATIENTS WITH BREAST CANCER
Company Collaborates with Leading Translational Investigator Experienced in Peptide Vaccine Trials
TORONTO -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that its wholly owned subsidiary, Antigen Express, has entered into a Collaborative Research and Development Agreement (CRADA) with the Uniformed Services University of the Health Sciences (USU) and The Henry M Jackson Foundation for the Advancement of Military Medicine, Inc. (Foundation) to work with LTC George Peoples, MD, Medical Corps, U.S. Army, to advance HER-2/neu vaccine efforts for breast cancer. Dr. Peoples is assigned to the Walter Reed Army Medical Center (WRAMC) and works in conjunction with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally mandated civilian-military collaboration between WRAMC, USU, the Windber Research Institute (Windber, PA) and the Foundation. The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment. HER-2/neu vaccine efforts under the CRADA will incorporate the Antigen Express proprietary Ii-Key technology to stimulate cancer patients' immune cells to attack HER-2/neu expressing tumor cells. Prior studies have shown this technology to be successful in stimulating cancer patients' immune cells in test tubes and in live animal models.
"Collaboration with Dr. Peoples and the CBCP will significantly strengthen our HER-2/neu vaccine development efforts and our ability to perform expeditious and meaningful clinical trials," said Eric von Hofe, Vice President for Technology Development at Antigen Express. Dr. Peoples has already conducted several clinical trials with unmodified HER-2/neu peptides. The results of those studies showed some immune stimulation and possible benefits to patient outcome. "The added stimulation provided by Antigen Express peptide modifications has a good chance of increasing response sufficiently to result in clear-cut efficacy," said Dr. von Hofe.
Antigen Express technology focuses on antigen-specific augmentation of the T helper component of the immune response. While early peptide vaccines focused on stimulating cytotoxic T cells (CTL), the importance of the T helper response is now viewed as crucial to mounting an effective anti-tumor response. "The clinical importance of T helper stimulation has been shown most clearly by adoptive transfer trials conducted at the National Institutes of Health," explained Dr. Robert Humphreys, Chief Scientific Officer at Antigen Express. "Without T helper cells there was essentially no response to the therapy, while the addition of T helper cells back to the mix of stimulated lymphocytes re-infused into the patient resulted in nearly a 50% response rate," continued Dr. Humphreys.
The strategy employed by Antigen Express is to develop a peptide vaccine that forces antigen specific stimulation of T helper cells. This vaccine strategy is dramatically simpler and less expensive than adoptive transfer. The core of the technology is modifying antigenic peptide epitopes (e.g., from the HER-2/neu cancer-related antigen) that force them to be presented to T helper cells by MHC class II molecules, which are the immune system's gatekeeper for antigen-specific T helper stimulation. Additional applications using this technology to target other cancers, viral infections and autoimmunity are in development.
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.
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755 or +1-416-364-2551; or Ken Sgro of CEOcast, Inc., +1-212-732-4300, kensgro@ceocast.com, for Generex Biotechnology +Corporation
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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