GNBT - Generex Biotechnology Receives Key Japanese Patent for Novel Technology to Enhance T Helper Cell Recognition of Cancer and Bioterrorism Antigens
PR Newswire - May 13, 2004 08:31
Novel T Helper Cell Stimulating Compounds Holds Promise for Rapid Advance to Clinic
TORONTO, May 13, 2004 /PRNewswire-FirstCall via COMTEX/ -- Generex Biotechnology Corporation (Nasdaq: GNBT), announced today the award of Japan patent 3534761 to its Antigen Express affiliate for certain Ii-Key immunologically active compounds and their use in modifying immune responses to antigenic eptitopes recognized by T helper and T suppressor cells.
"We are very pleased, after many years of review, that the Patent Office of Japan has awarded us a significant patent, which was previously awarded in the United States," said Dr. Robert Humphreys, Executive Vice President of Antigen Express and Chief Scientific Officer. "These compounds have great potential to protect against or control the course of a wide range of diseases. The discovery of this technology is based in the understanding and use of a basic biological mechanism regulating antigen presentation to the immune system."
Dr. Humphreys explained further that the patented technology represents the culmination of studies he began as a postdoctoral fellow with Dr. Jack Strominger at Harvard University. Dr. Humphreys was the first person to isolate the MHC class II receptor proteins and its regulatory protein called "Ii." He subsequently showed in detail how fragments of the Ii protein regulate charging of MHC class II with antigenic peptides for presentation to the immune system. This work was done while he was Professor of Pharmacology and Medicine at the University of Massachusetts Medical School and interim Chair of Pharmacology.
One of the Ii fragments, called 'Ii-Key,' acts on a regulatory site on the MHC class II molecule and controls the association of that molecule with antigenic peptide fragments. Binding of 'Ii-Key' to this regulatory site on the MHC class II receptor loosens its grip on any resident antigenic peptide. By exploiting this activity, drugs can be designed to spill antigenic peptides that lead to unwanted immune stimulation, thereby suppressing diseases such as multiple sclerosis or asthma.
The patent defines examples of such regulatory fragments of the Ii protein and their use to augment or suppress immune responses. Simple words, but the power of the mechanisms has substantial commercial and therapeutic implications.
In addition, vaccine peptides can be linked to Ii-Key to greatly increase their potency. Antigen is pursuing programs for the use of these compounds in therapeutic vaccines for HIV, SARS, and smallpox as well as for cancers of the prostate, breast, colon, ovary and lung. Hybrids of the Ii-Key linked chemically to an antigenic epitope have been shown to act as curative vaccines in mouse models of human diseases.
Antigen Express has received 9 grants from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the Department of Defense for the development of these compounds for many vaccine and treatment purposes.
Some papers present this work in detail.
Kallinteris NL, Lu X, Wu S, Hu H, Li Y, Gulfo JV, Humphreys RE, Xu M. Ii-Key/MHC class II epitope hybrid peptide vaccines for HIV. Vaccine 2003;21:4128-32.
Gillogly ME, Kallinteris NL, Xu M, Gulfo JV, Humphreys RE, Murray JL. Ii-Key/HER-2/ neu MHC class-II antigenic epitope vaccine peptide for breast cancer.Cancer Immunol Immunother. 2004;53:490-6.
"We are very please to have the work of our scientists recognized by the Patent Office of Japan and in addition to the United States," said Anna Gluskin, CEO of Generex. "The strong patent position is a primary component of our business development strategy around these compounds. We expect over the coming months to see additional reports and papers from this strong work by our scientists and collaborating academics." It is important to recognize the synergy between the work of Antigen Express and our own work with the RapidMist technology to deliver drugs and peptides, such as insulin. In cases where antigenic immunoregulatory peptides developed by Antigen Express must be administered twice a day, to control a disease process such as an acute flare in multiple sclerosis, only the needless RapidMist method of administration will be accepted by patients and physicians."
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.
SOURCE Generex Biotechnology Corporation
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
(GNBT)
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