WORCESTER, Mass., March 12, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has finalized the protocol for Metcontrol(tm), the Company's proprietary Metformin chewing gum product, and will be proceeding with applications to regulatory agencies for approval of the protocol for a clinical study. The protocol is an Open-Label Crossover Study comparing Generex's Metformin chewing gum and immediate release tablets in healthy volunteers.
The Company anticipates that approximately 75-100 patients will participate in the study.
Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving insulin sensitivity by the cells. Through this action, Metformin allows the insulin produced by the body to be used more effectively and ultimately reduces the amount of glucose in the blood. Metformin is the backbone of all treatment for Type 2 Diabetes Mellitus. It has a broad range of beneficial qualities for this extremely complex disease. Despite the fact that it is the most prescribed drug for Type 2, there are still millions who do not use it because of a variety of factors, including gastrointestinal side effects, large pill size and bitter taste (especially in the burgeoning population of children with Type 2). The delivery of Metformin in a good tasting chewing gum format may make the drug more acceptable to these patients and may increase compliance with the therapy.
The R&D path that leads to commercialization of this product is not anticipated to be as lengthy as a typical NCE (New Chemical Entity), as Metformin itself is not a new active compound. It is a well established active that has been accepted globally for the treatment of patients with diabetes.
"We are pleased to have completed this very key piece of the puzzle in the development of our Metformin gum product," said Anna Gluskin, the Company's President and Chief Executive Officer. "The goal of the Metformin gum development is to provide an alternative method of drug delivery that will improve both safety profiles and therapeutic compliance."
About Generex
Generex is engaged in the research, development, and commercialization 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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in various stages of clinical development around the world. For more information, visit the Generex website 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 undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. 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.