WORCESTER, Mass., Sept. 16, 2008 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has reached the enrollment milestone of more than two hundred subjects in the company's pivotal Phase III clinical trial of Generex Oral-lyn(tm), its flagship proprietary prandial oral insulin spray product. There are 74 sites in the United States, Canada, Bulgaria, Poland, Romania, Russia and Ukraine actively screening and enrolling subjects.
"The Generex Oral-lyn(tm) trial is now well underway and we are satisfied that the team's efforts in setting up the project and selecting the sites for participation translated into such fast enrollment rates. We look forward to continue enrolling additional qualified subjects to reach our next project milestone on schedule in the coming weeks," said Diana Fowler of OSMOS Clinical Research, Inc. (www.osmos.us) of San Francisco, California. OSMOS is the Company's provider for the global project management services for the trial.
The Phase III study will involve up to 750 subjects with Type-1 Diabetes Mellitus at centers in the United States, Canada, Bulgaria, Poland, Romania Russia and Ukraine. The objective of the long-term study is to compare the efficacy of Generex Oral-lyn(tm) and the company's RapidMist(tm) Diabetes Management System with prandial injections of regular human insulin as measured by HbA1c.
The company believes that Generex Oral-lyn(tm) will offer a safe, simple, fast, effective, and pain-free alternative to prandial insulin injections, which will improve subject compliance with therapeutic regimes, thereby delaying the progress of diabetes and the onset of its myriad complications.
Generex Oral-lyn(tm) is presently approved for commercial sale in India and Ecuador.
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 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 subjects with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at www.generex.com.
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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. Generex Contacts:
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