Update on Generex’s Phase III Trial of Oral-lyn

Dosing initiated in over one hundred patients in the trial. Product Presently Approved For Commercial Sale In India And Ecuador.

Generex, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has initiated dosing of over one hundred patients in the Company’s pivotal Phase III clinical trial of, Generex Oral-lynÔ, its flagship proprietary oral insulin spray product. Dosing of patients is now underway at 31 clinical trial sites in the United States, Canada, Russia, and Ukraine.

“We are pleased to report that the Generex Oral-lyn trial is now well underway,” said Boris Iossel, President of OSMOS Clinical Research, Inc, the Company’s global project manager for the trial. “We look forward to the continuing the enrollment and dosing of additional patients in the coming weeks.”

The Phase III study will involve up to 750 patients with Type-1 Diabetes Mellitus centers in the United States, Canada, Russia, and Eastern Europe. The objective of the six-month 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.

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.

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.