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Tuesday 21 February 2006

DiObex Takes Novel Cortisol Synthesis Inhibitor Into Phase 2 Clinical Trial

By: DiObex, Inc.

DiObex, Inc., a privately-held pharmaceutical company focused on the development of therapeutics to treat metabolic diseases, today announced that it has begun treating patients with type 2 diabetes in a randomized, placebo-controlled clinical trial. Patients will be treated for two weeks to evaluate the safety and pharmacokinetics of three dose levels of the Cortisol Synthesis Inhibitor, DIO-902.

There are convincing data supporting the concept that abnormalities in cortisol activity are an important cause of insulin resistance, visceral fat deposition, elevated cholesterol and blood pressure. These abnormalities, commonly present in patients with type 2 diabetes and obese pre-diabetic patients, increase the risk of cardiovascular disease.

"We are very excited at the prospect of continuing human clinical development for this novel Cortisol Synthesis Inhibitor. Many big pharma companies are in hot pursuit of this target and we believe that DIO-902 is at the head of the pack in the advancement of this new and exciting class of drugs," commented Daniel Green, President of DiObex.

DIO-902 (2S,4R ketoconazole) is one of the two enantiomers contained within the racemate of the drug ketoconazole. A racemate is a mixture of equal quantities of two enantiomers, substances whose molecular structures are mirror images of one another. DIO-902 has been proven to be both more effective and safer than the racemate in preclinical studies.

"The data generated for racemic ketoconazole in patients with type 2 diabetes demonstrated that inhibition of cortisol synthesis provided substantial clinical benefits not only in controlling glucose levels but also in lowering both blood pressure and cholesterol," said Dr. Timothy Stewart, Vice President of Research at DiObex. "DIO-902 has been shown in preclinical experiments to be responsible for virtually all of the cortisol synthesis inhibitory activity present in the racemate. In addition, DIO-902 has characteristics which, if reproducible in humans, could lead to a drug that is not only more potent, but also substantially safer than the racemate."

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