GTx, Inc. (Nasdaq: GTXI) today announced that a per protocol interim safety review on Friday, October 26, 2012, by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. The DSMB meets every six months to review safety data from the two pivotal Phase III clinical trials, POWER 1 and POWER 2.
“The DSMB reviewed safety data from the subjects enrolled in our two pivotal Phase III clinical trials and recommended that GTx continue with the trials as planned,” said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. “The extensive safety database GTx is compiling from approximately 9 clinical studies of enobosarm will be a critical component of the application for marketing approval we hope to submit following receipt of topline data from our Phase III clinical trials in the 2 nd quarter of 2013.”
GTx is currently enrolling subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III 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 III or IV non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm 3 mg at the time they begin first line standard chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus 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. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment. Enrollment for both studies is expected to be completed in the fourth quarter of this year, and topline results should be released during the second quarter of 2013.