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OSI commences early stage trial of diabetes drug

OSI Pharmaceuticals has initiated a phase I clinical study of its diabetes drug, PSN357, which is designed to rapidly lower blood glucose levels.

The study is scheduled to enroll up to 112 healthy volunteers, and will follow a dose escalation program that is designed to determine the safety and tolerability of PSN357. The study is aimed at facilitating a phase II “proof-of-concept” clinical program in diabetes patients.

“The science behind our research efforts is focused on the development of next-generation small molecule compounds designed to develop safer, more effective and innovative products for the treatment of metabolic diseases, particularly type 2 diabetes and obesity,” stated Dr Anker Lundemose, president of Prosidion, OSI’s diabetes and obesity team. “We believe PSN357’s ability in pre-clinical studies to inhibit glycogen phosphorylase and reduce blood glucose levels may ultimately offer a competitive therapeutic option for diabetes patients.”

Pre-clinical data presented at the 2005 American Diabetes Association’s Annual Scientific Session showed that PSN357 inhibits GP and reduces blood glucose levels in animal models with diabetes following acute and chronic dosing. An increase in liver glycogen was also seen in the study; however heart and skeletal muscle glycogen showed no changes from controls.