WORCESTER, Mass., Feb. 4, 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 on February 1st, 2008, an Investigators' Meeting was held in St. Petersburg, Russia for the launch of the Company's global Phase III study for Generex Oral-lyn(tm). The Investigators' Meeting was attended by more than 150 clinicians and healthcare professionals.
There are 72 clinical centers in seven countries which have been selected by Generex to participate in the trial. The centers chosen by the Company are located in the USA, Canada, Russia, the Ukraine, Romania, Bulgaria and Poland.
The multi-center, randomized Phase III trial will include up to 750 patients with Type 1 diabetes mellitus. The primary objective of the study, Protocol GEN-084-OL, is to compare the efficacy of Generex Oral-lyn therapy using the Company's proprietary RapidMist(tm) Diabetes Management System with that of standard regular injectable insulin therapy as measured by HbA1c in patients with Type 1 diabetes mellitus. The results stemming from this trial will be submitted in support of applications for Generex Oral-lyn approval filed with Health Canada, EMEA and the FDA.
Generex Oral-lyn is a prandial (mealtime) insulin which allows for easy self-administration, precise dosage control and easy titration making possible finer, more individualized glucose control. As such, Generex Oral-lyn also makes an ideal supplement at meal times for patients with Type 2 diabetes mellitus in addition to basal therapies or combination therapies based on blood glucose measurements.
Generex believes that early intervention with insulin therapy could delay the onset and progression of diabetes and its numerous complications and thereby increase longevity.
"We are very pleased by the feedback from the Investigators' Meeting," said Anna Gluskin, Generex's President and Chief Executive Officer. "The enthusiasm evidenced by the large attendance in St. Petersburg illustrates the European and East European medical community's interest in and excitement about participating in this trial. After many months of meticulous preparations, Generex continues to steadfastly follow its course in order to bring a more convenient, compliance-friendly insulin alternative to patients," she added.
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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), 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.