Phase 3 Trial of Enobosarm (GTx-024) for Muscle Waste Prevention in Lung Cancer

GTx announced that an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase 3 trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

GTx is currently enrolling subjects with advanced non-small cell lung cancer in two pivotal Phase 3 clinical trials, POWER 1 and POWER 2. These international studies are being conducted in clinical sites in the United States, Europe, and South America. In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage 3 or 4 non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm 3mg at the time they begin first line standard chemotherapy.

The co-primary endpoints are the response rates of enobosarm vs. placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test at three months of treatment. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment.

Enobosarm is an investigational selective androgen receptor modulator (SARM).

For more information call (901) 523-9700 or visit www.gtxinc.com.