Generex progresses Ph III Oral-lyn trial

Canada's Generex Biotechnology says that an investigator's meeting has been held in St Petersburg, Russia, for the launch of a global Phase III study of its oral insulin product Generex Oral-lyn. 72 clinical centers located across the USA, Canada, Russia, the Ukraine, Romania, Bulgaria and Poland have been selected to participate in the trial, the firm noted.

The multicenter, randomized Phase III evaluation will include up to 750 patients with type 1 diabetes mellitus. The primary objective is to compare the efficacy of Generex Oral-lyn therapy using the company's proprietary RapidMist Diabetes Management System with that of standard regular injectable insulin therapy as measured by HbA1c. The results from this trial will be submitted in support of applications for Generex Oral-lyn approval filed with Health Canada, the European Medicines Agency (EMEA) and the US Food and Drug Administration, the firm noted.