GTx achieves enrollment goal for pivotal Phase III clinical studies of enobosarm

Dec 17 2012

GTx, Inc. (Nasdaq: GTXI) today announced that it has attained its enrollment goal for both of its pivotal Phase III clinical studies of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients.

“After the last patient completes each of the five month studies, we expect to receive top line data during the latter part of our second quarter in 2013. We are excited about the potential of enobosarm to prevent and treat muscle wasting in patients suffering from non-small cell lung cancer.”

"More than 600 patients in the United States, Eastern Europe and South America are now participating in our two definitive Phase III clinical studies of enobosarm," said Mitchell Steiner, MD, CEO of GTx. "After the last patient completes each of the five month studies, we expect to receive top line data during the latter part of our second quarter in 2013. We are excited about the potential of enobosarm to prevent and treat muscle wasting in patients suffering from non-small cell lung cancer."

GTx is assessing the ability of enobosarm to prevent and treat muscle wasting in non-small cell lung cancer patients in two pivotal Phase III clinical trials, POWER 1 and POWER 2. In each of the placebo-controlled, double-blind clinical trials, approximately 300 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first line standard platinum doublet chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the responder rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function measured by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment.

SOURCE GTx, Inc.