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United States Awards Patent to Antigen Express Subsidiary of Generex Biotechnology

Posted on: Thursday, 27 January 2005, 12:00 CST

TORONTO, Jan. 27 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation announced today that its wholly owned subsidiary, Antigen Express, has received United States Patent US 6,835,382 B2 as of December 28, 2004. This award continues the divisional prosecution of an original application filed March 3, 1999. The specific award covers the use of Ii-Key peptide homologs to inhibit antigen presentation. It bears on potential treatments of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and diabetes mellitus.

Dr. Robert Humphreys, the Chief Scientific Officer of Antigen Express has spent his lifetime understanding how antigenic peptides are presented to the immune system and how novel treatments for disease might be designed. As a research fellow at Harvard University, he first isolated the MHC class II molecules, which present antigenic peptides to T helper cells, which regulate the immune response. He also discovered the immunoregulatory Ii protein that binds naturally into the antigenic peptide-binding site of those MHC class II molecules. He discovered a segment of the Ii protein, the Ii-Key peptide, which acts on MHC class II molecules to regulate peptide binding or exchange. Recently he and his colleagues at Antigen Express have discovered and patented novel hybrid peptides in which the immunoregulatory Ii-Key peptide is linked covalently to antigenic epitopes. By controlling the presentation of antigen peptides to the immunoregulatory T helper cells, new classes of drugs can be developed to enhance vaccines or to suppress autoimmune disease.

The Antigen Express compounds can either enhance or block presentation of antigenic epitopes to immunoregulatory T cells. In laboratory studies, such Ii-Key hybrids enhance presentation of the antigenic peptides 200-1000 times in test tube assays and make vaccines in animals about 10 times more potent. There are significant clinical and commercial potentials for these types of compounds as vaccines for cancer and infectious disease, and in diagnosing and suppressing autoimmune disease. Antigen Express has active research programs, some funded by the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the Department of Defense, for breast and prostate cancers and melanoma, and for infectious diseases such as influenza, smallpox, SARS and HIV.

In extension of the focus of Generex Biotechnology on the therapy of diabetes, Antigen Express scientists have applied their proprietary and patented techniques to develop novel diagnostics for type I or juvenile diabetes. Some individuals exhibit autoimmune reactions to various antigens associated with the pancreatic beta cells, which produce insulin in healthy individuals. The initial goal has been to identify persons who have such reactions prior to onset of frank disease, when the pancreatic beta cells have been destroyed by the autoimmune disease. As part of a long-range plan to develop novel therapies for diabetes mellitus, the types of inhibitor covered in this patent might come to be relevant. They might also come to be applied in treatments of rheumatoid arthritis or multiple sclerosis.

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.

Generex Biotechnology Corporation

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

Source: PRNewswire-FirstCall

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