WORCESTER, Mass., March 11, 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 canisters of Generex Oral-lyn(tm), the Company's proprietary oral insulin spray product, have been labeled and packaged for Phase III clinical trial sites in the United States, Canada and Ukraine. Both placebo and active canisters are ready to be shipped to the clinical sites which will permit the initiation of the pivotal study. Clinical supplies of canisters for the balance of the sites are scheduled to be labeled and packaged in the next 45 days.
The Phase III protocol, identified as GEN084-OL, calls for a six-month trial which is expected to include 750 patients with Type-1 diabetes mellitus. The Company previously received a non-objection letter from Health Canada to conduct this pivotal study and the FDA did not object to the study. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the RapidMist Diabetes Management System with that of standard regular injectable human insulin therapy as measured by Hba1c in patients with Type-1 diabetes mellitus.
"We are systematically implementing our action plan to commence patient dosing at all global Phase III centers for our flagship product," said Anna Gluskin, the Company's President and Chief Executive Officer. "We believe that our careful planning and attention to detail will ensure a smooth transition from drug handling to dosing. Previous studies conducted using Generex Oral-lyn have demonstrated an excellent safety profile and promising results, providing us with confidence that Generex Oral-lyn represents the first safe and effective alternative to needle sticks for millions of patients with diabetes."
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 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 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.