6/1/2004 Generex Biotechnology Initiates late Pre-Clinical Studies to Prepare for Vaccine Trials in Patients with Her-2/neu Positive Ovarian Cancer
Company Collaborates with Leading Cancer Center in Greece toward Clinical Studies
TORONTO -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that its wholly owned subsidiary, Antigen Express, has established a collaboration with Saint Savas Cancer Center in Athens, Greece to use modified peptide antigens to stimulate cancer patients' immune cells. Success in these test tube studies, as has been demonstrated with immune cells from patients with Her-2/neu positive breast cancer, should lead to clinical vaccine trials in patients with ovarian cancer.
"We look forward to bringing our lead compounds for anticancer vaccines into these late preclinical studies, in anticipation of early clinical trials." explained Dr. Eric von Hofe, Vice President for Technology Development. "Previously, we showed that blood cells from patients with Her-2/neu positive breast cancer are dramatically stimulated by antigenic peptide epitopes, which have been modified by Antigen Express technology. This new collaboration expands the testing of our technology for additional use in patients with ovarian cancer. After years of innovative and comprehensive studies in laboratory models, we are now taking these novel agents to a clinical setting."While the focus of cancer immunotherapy strategies was initially only on the direct stimulation of cytotoxic T cells (CTL), Antigen Express has been perfecting technologies for antigen specific stimulation of T helper cells, another main class of immune cells in the body. A consistent story from clinical trials using CTL-stimulating strategies is the critical need for T helper stimulation. The importance of T helper cell stimulation has been further underscored by results from laboratory models at Antigen Express, as well as independently at leading academic institutions.
The core of the Antigen Express technology involves modification of an antigenic peptide epitope (e.g., from the Her-2/neu protein) that forces it to be presented to T helper cells by MHC class II molecules, which serve as the immune system's gatekeeper for antigen-specific T helper stimulation. The modification that forces presentation of the epitope is derived from a portion of the MHC class II associated protein, termed the Ii protein or invariant chain, which associates at synthesis with MHC class II molecules. When that portion of the Ii protein (termed the Ii-key) is added to an antigenic epitope, the avidity of the epitope for MHC class II molecules goes up over 200-fold and actively displaces any epitope currently being presented by MHC class II molecules. This allows the Ii-key/epitope 'hybrid' to bypass all the normal MHC class II antigen processing controls and exploit any MHC class II molecule that it comes in contact with, forcing it to present the therapeutic antigenic epitope.
The specific compound to be investigated in this collaboration can be used to vaccinate against all cancers expressing the Her-2/neu protein, which includes not only breast and ovarian cancer but also cancers of the prostate, colon and lung. "While we are excited about our Her-2/neu hybrid," commented Robert Humphreys, the company's founder and Chief Scientific Officer, "it is important to keep in mind that this is truly a platform technology. In any pathological condition where antigen-specific immunomodulation can have a beneficial effect, Ii-Key hybrids can positively impact the course of disease, be it cancer, viral infection or autoimmune disease." "We are pleased to see the rapid advance of projects of our scientists at Antigen Express toward the clinic." said Anna E. Gluskin, President and Chief Executive Officer of Generex. "The data obtained so far with clinical samples are very encouraging and we look forward to expanding these efforts through additional corporate and academic collaborations."
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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