Generex Biotechnology announces North American initiation of Generex Oral-lynT Phase III Diabetes Study
Generex Biotechnology Corporation announced that it has initiated the Phase III protocol in North America for its proprietary buccally-absorbed oral insulin spray product, Generex Oral-lyn, with the commencement of patient screening. The first screening took place in late March in Texas. Other clinical sites participating in the study located in the United States are in Texas, Maryland, Minnesota and California, and in Canada in the province of Alberta.
The Phase III protocol, identified as GEN084-OL, calls for a six month trial which is expected to include 750 patients with Type-1 diabetes mellitus. The primary objective of the study is to compare the efficacy of Generex Oral-lyn and the RapidMistT Diabetes Management System with that of standard regular injectable insulin therapy as measured by Hba1c in patients with Type-1 diabetes mellitus. Generex 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.
"This clinical milestone represents a long history of research and development to optimization for Generex Oral-lyn which is now entering the final clinical stage in major jurisdictions," said George Markus, the Company's Vice President of Regulatory Affairs. "Our product is designed to offer a safe and convenient alternative to prandial insulin injections which can improve treatment compliance and quality of life for patients with diabetes."
Generex Oral-lyn is presently approved for commercial sale in India and Ecuador. The delivery of Generex Oral-lyn clinical supplies to global sites and centers, including Ukraine and Russia, is on-going with roll-out to other regions to follow.
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