Generex Announces Positive Results of Metformin Chewing Gum Trial
Results suggest that the Company's Metformin chewing gum is therapeutically equivalent to traditional Metformin tablets
WORCESTER, MA, December 2, 2008 (GlobeNewswire) - Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced results from a clinical trial of MetControlT, the Company's proprietary Metformin chewing gum product. Results of this fully compliant ICH-GCP conducted study indicate that the MetControl Metformin chewing gum and traditional Metformin tablets are bioequivalent in respect of both the rate and the extent of systemic absorption such that MetControl and Metformin tablets are therapeutically equivalent and therefore interchangeable.
The protocol for the study is an open-label, two-treatment, two-period, randomized, crossover study comparing MetControl and immediate release Metformin tablets in healthy volunteers. The study is being conducted at West Houston Clinical Research Services in Houston, Texas. The primary objective of the study is to determine if MetControl is bioequivalent to traditional immediate release Metformin tablets.
Twenty-four healthy subjects were selected for enrollment in the study, to evaluate the bioequivalence of 2 x 250 mg MetControl in comparison to 500 mg Metformin tablets. The subjects received one assigned treatment during the first period and received the alternate treatment during the subsequent period. A seven (7) day washout was included between the dose administrations.
No Serious Adverse Events (SAE's) have been reported during the study.
Blood samples were collected and Metformin was analyzed in plasma. Statistical analysis was performed to compare the bioequivalence of MetControl to the Metformin tablets. Bioequivalence was established with a Power of 1 based on 90% Confidence Interval (CI). Preliminary data obtained from the study reveals that at a 90% CI, the area under the drug plasma concentration over time curve (AUC) and the average maximum Metformin plasma concentration (Cmax) were within the bioequivalence accepted range of 80% - 125%. The same profiles were also observed in log-transformed data.
Upon final confirmation of statistical data, it is the Company's intention to proceed with various submissions for regulatory approval of MetControlT as a generic Metformin product. 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.
Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving the insulin sensitivity of 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 almost all treatments 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 diabetes, 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 diabetes). The delivery of Metformin in a pleasant tasting chewing gum format may make the drug more acceptable to these patients and may thereby increase compliance with the therapy.
"These results are very encouraging," said Anna Gluskin, Generex's President & Chief Executive Officer. "We look forward to proceeding with the regulatory path to product commercialization. MetControl will be a complimentary product to Generex Oral-lynT, our proprietary oral insulin spray product."
About Generex Biotechnology Corporation
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 RapidMistT device. The Company's flagship product, oral insulin (Generex Oral-lynT), which is available for sale in India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.
Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of 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.
Posted: December 2008