OSI advances diabetes program with phase 1 study

By Lisa Kerner

Erie, Pa., Feb. 15 - OSI Pharmaceuticals, Inc. said it has begun a phase 1 clinical study of PSN010, a glucokinase activator that lowers blood glucose levels by increasing glucose uptake in the liver and increasing insulin secretion from the pancreas.

PSN010 is OSI's second clinical candidate to emerge from its research efforts in diabetes, according to a company news release.

The single-center, double-blind, single dose escalation phase 1 study of 80 healthy volunteers is designed to provide preliminary information on the safety, tolerability, pharmacokinetics and pharmacodynamics of PSN010.

According to the release, study results will facilitate the design of a multiple dose study in healthy subjects and a phase 2 proof-of-concept clinical study in diabetes patients.

Preclinical data showed that PSN010 activates glucokinase strongly in vitro and in vivo, while the antihyperglycemic capabilities of PSN010 have been confirmed in several diabetic rodent models, the company said.

"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," executive vice president Anker Lundemose said in the release.

OSI, based in Melville, N.Y., develops pharmaceutical products that extend life or improve the quality of life for patients with cancer, eye diseases and diabetes.

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