SOURCE: Generex Biotechnology

September 19, 2006 09:15 ET

Generex Biotechnology Supported Research Has Podium Presentation at the 42nd Annual Meeting of the European Association for the Study of Diabetes

TORONTO -- (MARKET WIRE) -- September 19, 2006 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that internationally renowned diabetes investigators Professor Paolo Pozzilli and Dr. Marta Vadacca, both of the Department of Endocrinology and Diabetes at University Campus Bio-Medico, Rome, Italy, made a podium presentation of the results of a research project sponsored by Antigen Express, Inc., a wholly owned subsidiary of the Company, at the 42nd Annual Meeting of the European Association for the Study of Diabetes (EASD) (www.easd.org) in Copenhagen, Denmark, on September 17, 2006.

Professor Pozzilli and Dr. Vadacca presented their paper entitled "Ii-Key/Insulin MHC Class-II Antigenic Epitope Peptides in Type 1 Diabetes" co-authored with Robert E. Humphreys, Nikoletta L. Kallinteris, Luciana Valente, and Giuditta Valorani.

The investigators described the potential of the Antigen Express technologies to more sensitively and accurately diagnose patients with Type 1 diabetes which could lead to the identification of subjects at high risk for the disease. Type 1 diabetes, which occurs in children and young adults, is frequently associated with an autoimmune response to insulin. Using fragments of the insulin protein (peptides) modified by proprietary 'Ii-Key' technologies developed by Antigen Express, it was possible to detect T helper immune cells in the peripheral blood of some patients with recent onset Type 1 diabetes that had developed an aberrant autoimmune response to insulin. Unmodified insulin peptides were inactive in picking up activated T cells. Given that the clinical management of diabetics is different depending on whether or not there is a specific autoimmune response, this technology offers hope for earlier intervention in the management of diabetics to help prevent some of the long-term debilitating effects of diabetes. While not addressed in the current studies, the identification of Ii-Key-modified insulin peptides that are more sensitively recognized by immune cells offers hope for being able to specifically suppress the autoimmune cause of Type 1 diabetes.

The aims of the EASD are to encourage and support research in the field of diabetes, the rapid diffusion of acquired knowledge, and the facilitation of its application. The EASD currently has more than 5,500 active individual members from over 100 countries.

About Generex

Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in Ecuador for the treatment of patients with Type 1 and Type 2 diabetes, is in various stages of clinical trials around the world. For more information, visit the Generex Web site at www.generex.com.

Safe Harbor Statement: 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 cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

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