Generex Biotechnology Achieves Enrollment of Over 400 Subjects in Phase III Generex Oral-lyn Study
Generex Biotechnology Corporation announced that it has achieved enrollment 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.
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