RxTrials Institute Drug Pipeline Alert

Generex Biotechnology has started patient screening in the Phase III program for its oral insulin spray Generex Oral-lyn in North America.

The Phase III protocol includes a six-month trial, which is expected to enroll 750 patients with Type 1 diabetes mellitus. The study’s primary objective is to compare the efficacy of Generex Oral-lyn and the RapidMist diabetes management system with standard injectable insulin therapy, Generex said.

Generex Oral-lyn is approved in India and Ecuador. The company also is studying the product in the Ukraine.