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DiObex Begins Dosing Patients in Phase 2b Trial of Type 2 Diabetes Drug
Date:9/26/2007

Multinational Trial to Evaluate Safety, Efficacy of Novel Cortisol

Inhibitor

SAN FRANCISCO, Sept. 26 /PRNewswire/ -- DiObex, Inc., a privately held biotechnology company focused on the development of therapeutics to treat metabolic diseases, announced today that it has begun dosing patients in a Phase 2b clinical trial of DIO-902, a novel cortisol synthesis inhibitor being studied for the treatment of type 2 diabetes mellitus (T2DM).

The Phase 2b multinational trial is a randomized, placebo-controlled, double-blinded study designed to evaluate the safety and efficacy of DIO-902 and to determine dosing for pivotal Phase 3 clinical studies. The primary efficacy endpoint being evaluated is the change in HbA1c, a key measurement of glycemic control, compared to placebo. Secondary endpoints include the change in total and LDL-cholesterol, and the change in blood pressure. Top line data from the trial is expected by the second half of 2008.

"The rollout of this multinational, multicenter trial demonstrates DiObex's ability to launch a major clinical program for the treatment of metabolic disease," CEO David Cory said. "With treatments for both type 1 and type 2 diabetes in mid-stage clinical study and additional indications under evaluation for DIO-902, DiObex is well positioned to move a strong pipeline of product candidates into the advanced stages of development."

The trial is being conducted at 20 centers across the United States, Australia and New Zealand. Approximately 200 patients will be treated for 16 weeks. Patients who are already on a stable dose of metformin will be randomized to receive placebo or one of three doses of DIO-902 once daily for 16 weeks, with the option of continuing on an open label extension for an additional six months of treatment.

Preclinical and clinical studies have suggested that a link exists between high cortisol levels and visceral adiposity, insulin resistance
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SOURCE DiObex, Inc.
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