WORCESTER, Mass., May 10, 2010 (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, today announced that it has achieved enrolled of over 400 subjects in its pivotal global Phase III study of its flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product designed to replace prandial injections of insulin.
Generex will continue to monitor and execute the ongoing Generex Oral-lyn™ study according to protocol and national/international ICH-GCPs. The study's endpoint is for Generex Oral-lyn™ to achieve non-inferiority to injectable meal-time (prandial) insulin. Formal verification of the non-inferiority hypothesis should be achieved by the statistical power set out in the protocol. Following the execution of the study's first interim analysis in approximately two months, the enrollment of additional subjects in the study may possibly be terminated. This in turn would establish an approximate end-of-study-treatment-period in December 2010.
To date, no Generex Oral-lyn™ drug-related "Serious Adverse Events" (SAEs) have been reported, which also supports the current initiatives of the study.
"We are pleased with the progress of the Phase III study for Generex Oral-lyn™ to date in each of the global sites," said Anna Gluskin, Generex's President & Chief Executive Officer. "We remain confident that the results of this pivotal global study will remain consistent with all historical studies of our flagship product that have been successfully conducted to date. The results will form the basis of our upcoming NDA submission in the US. In parallel, to help Americans today that have Type 1 or 2 Diabetes who cannot use injectable insulin, treatment use of Generex Oral-lyn™ will continue under the FDA's expanded access Treatment IND program until the upcoming filing of an NDA is approved. We are excited to know that this select population can be assisted until that goal is achieved."
The Company believes that Generex Oral-lyn™ offers a safe, simple, fast, effective and needle-free alternative to prandial insulin injections which will improve patient compliance with therapeutic regimens, thereby delaying the progress of diabetes and the onset of its myriad complications.
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, buccal insulin (Generex Oral-lyn™), which has been approved in India, Lebanon, Algeria, 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. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831
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.