Generex Biotechnology Commences Patient Dosing For Pivotal Phase III Trial Of Generex Oral-lyn For Type 1 Diabetes

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 09 Jun 2008 - 2:00 PST

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Generex Biotechnology Corporation (NasdaqCM:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has commenced dosing of patients in a Phase III clinical trial of the Company's flagship product, Generex Oral-lynO, an oral insulin spray.

The six-month Phase III study will involve up to 750 patients with Type-1 Diabetes Mellitus in thirty-six centers located in the United States, Canada, Russia, and Eastern Europe. The objective of the study is to compare the efficacy of Generex Oral-lyn and the Company's RapidMist™ Diabetes Management System with prandial injections of regular human insulin as measured by HbA1c.

Generex Oral-lyn, a liquid formulation of human regular insulin, is sprayed into the mouth with a simple device similar to inhalers used for the treatment of asthma. The oral insulin is buccally absorbed, with the size of the particles precluding entry into the lungs. The Company believes that Generex Oral-lyn will offer a safe, simple, fast, effective, and pain-free alternative to prandial insulin injections, which will improve patient compliance with therapeutic regimes thereby delaying the progress of diabetes and the onset of its myriad complications

"Diabetes Mellitus is an overwhelming worldwide problem. Many people do not achieve their treatment goals because of failure to use insulin. Buccal delivery affords an opportunity to correct that. As a principal investigator, I am pleased to announce that the international Phase III non-inferiority study of 750 patients has dosed its first patient," said Professor Philip Raskin, MD of The University of Texas Southwestern Medical Center at Dallas (http://www.utsouthwestern.edu), one of the clinical trial sites.

Generex Oral-lyn is presently approved for commercial sale in India and Ecuador. The delivery of Generex Oral-lyn clinical supplies to global sites and centers, including Ukraine and Russia, is ongoing with other regional roll-out to follow.

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™ 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 and which was approved for sale in India in October 2007, is in Phase 3 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 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 Biotechnology Corporation