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Six-Month Study Will Involve Up to 750 Patients With Type-1 Diabetes Mellitus
WORCESTER, MA, USA | June 5, 2008 | Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), 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-lyn(tm), 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(tm) 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 (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(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 Phase 3 clinical trials at several sites around the world. For more information, visit the Generex website at www.generex.com.
SOURCE: Generex Biotechnology Corporation |
