OSI begins phase 2a trial for its glycogen phosphorylase inhibitor, PSN357

By Lisa Kerner

Erie, Pa., Feb. 21 - OSI Pharmaceuticals, Inc. began a phase 2a clinical trial for its glycogen phosphorylase inhibitor, PSN357, which the company is developing for type 2 diabetes.

In the phase 2a study, PSN357 will be administered daily to up to 30 type 2 diabetic patients over an initial period of 14 days providing safety, pharmacokinetic and pharmacodynamic endpoints in a placebo-controlled, dose-escalation design, according to a company news release.

The study is expected to last about six months.

The phase 2a trial follows the completion of a phase 1 safety and tolerability study for PSN357. In the single-center, placebo-controlled, dose-escalation study, PSN357 was administered in single and multiple doses (daily dose for seven days) to 80 healthy volunteers.

OSI said the results showed no unexpected safety or pharmacokinetic outcomes.

"PSN357 is the first clinical candidate to emerge from the company's internal discovery research efforts in diabetes and is designed to prevent glucose levels rising in diabetic patients by preventing glycogen breakdown to glucose in the liver," Anker Lundemose, OSI executive vice president and president of (OSI) Prosidion, the company's U.K.-based diabetes research and development arm.

"We believe that PSN357, together with our DPIV inhibitor, PSN9301, which is scheduled to begin phase 2b studies this year, and PSN010, our glucokinase activator, which entered phase 1 trials last week, together comprise an innovative clinical pipeline of novel, molecularly targeted therapies for the treatment of type 2 diabetes."

OSI discovers, develops and commercializes novel pharmaceutical products for patients with cancer, eye diseases and diabetes. The company is based in Melville, N.Y.

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