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GTx Announces Ostarine Improved Insulin Resistance among Elderly,Patients in a Recently Completed Phase II Clinical Trial

trials using FDA approved diabetic drugs in a prediabetic population. For example, in a one year study (the DREAM study), prediabetic patients taking rosiglitazone 8 mg evidenced a decline in fasting blood glucose of 9% from their baseline measurements (Lancet, 2006). Similarly, in prediabetic patients taking glipizide 2.5 mg for 6 months, the mean fasting blood glucose decreased by 4 percent, insulin declined by 17%, and insulin resistance reduced by 35% (Erikson JG et al, 2006). In prediabetic patients taking metformin 1.7 g for 16 weeks, fasting blood glucose declined by 6%, insulin decreased by 29%, and the calculated insulin resistance decreased by approximately 39% (Bulcao C et al, 2007).

"The data from our Phase II clinical trial provide more evidence that Ostarine is having the desired anabolic effect," said Ronald A. Morton, Jr, MD, Chief Medical Officer of GTx. "By increasing muscle and decreasing fat, Ostarine appears to improve levels of glucose and insulin and to reduce insulin resistance. These data suggest Ostarine may have a beneficial impact on prediabetic conditions and potentially diabetes, which, if validated in later studies, could provide the basis for our seeking expanded indications for Ostarine."

"It would be clinically meaningful and exciting if Ostarine is shown to have an effect of similar magnitude in chronic kidney disease patients where diabetes and prediabetes are highly prevalent," said T. Alp Ikizler, MD, Associate Professor of Medicine at Vanderbilt University School of Medicine.

GTx is planning to initiate a Phase IIb clinical trial evaluating Ostarine for the treatment of chronic kidney disease muscle wasting by the end of the year 2007. Diabetes is a highly prevalent comorbidity among patients with chronic kidney disease. Nearly one half of treated Stage 3 and 4 chronic kidney disease patients are diabetic, and the majority of remaining patients are prediabetic. Testing Ostarine in this population will allow
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