Generex Biotechnology enrolls over 400 subjects in global Phase III study of Generex Oral-lyn

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.