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DiObex Presents Phase 2a Data of DIO-902 Demonstrating Trends of,Improved Glycemic Control and Significant Reductions of,LDL-Cholesterol and C-Reactive Protein

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DIO-902 is an oral, once-daily drug being developed for the treatment of type 2 diabetes. It is a single enantiomer of racemic ketoconazole which suppresses cortisol production by inhibiting the 11 beta hydroxylase enzyme, the terminal step in the adrenal synthesis of cortisol. This novel mechanism of action makes DIO-902 a first-in-category cortisol inhibitor.

"Our unique approach to inhibition of cortisol synthesis offers the potential to address one of the underlying causes of type 2 diabetes, as well as multiple co-morbidities associated with both the disease, and its precursor, metabolic syndrome," said David A. Cory, Chief Executive Officer of DiObex, Inc. "DIO-902 offers patients the promise of effectively managing glycemia and lipids with a single medication. We are excited about the preliminary data generated to date and are rapidly progressing DIO-902 to the next stage of clinical development."

Data from various preclinical, epidemiological and clinical studies have suggested that a link exists between high cortisol levels and visceral adiposity, insulin resistance, and hyperglycemia -- common elements of the metabolic syndrome and type 2 diabetes.

The two-week trial with DIO-902 enrolled 37 patients with type 2 diabetes who were randomized to placebo, three different doses of DIO-902 ( 200 mg, 400 mg and 600 mg) or ketoconazole. Patients were either drug naove or on metformin, and had lipid-lowering agents washed out for at least 21 days prior to the first dose of the study drug. No serious adverse effects related to the study drug were reported. Liver function tests were carefully monitored, and no clinically meaningful changes were observed in any of the treated subjects. In fact, a number of subjects enrolled with mild transaminase elevations normalized during the two week treatment.

DiObex will conduct a multi-center, 16-week, phase 2b dose-ranging study with DIO-902; this study is scheduled to start enrolling patien
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