Generex insulin spray enters US Ph III trial
Canada's Generex Biotechnology Corp has initiated a Phase III trial in North America for its proprietary buccally-absorbed oral insulin spray product, Oral-lyn, with the commencement of patient screening.
The Phase III protocol calls for a six-month trial which is expected to include 750 patients with type 1 diabetes. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the RapidMist Diabetes Management System with that of standard regular injectable insulin therapy as measured by Hba1c. Oral-lyn is delivered into the mouth via the company's proprietary RapidMist device. Unlike inhaled insulin products, buccally-absorbed Generex Oral-lyn does not enter the lungs, the firm noted. The agent is currently approved for commercial sale in India and Ecuador.
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