GTx, Inc. (Nasdaq: GTXI) today announced that a per protocol safety review of unblinded safety data on Friday April 12, 2013, by an independent Data Safety Monitoring Board (DSMB), resulted in a determination that GTx continue as planned its two pivotal Phase III clinical trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer. The DSMB has met regularly every six months to review safety data from the two pivotal Phase III clinical trials and will not meet again until the data is locked and unblinded for a final assessment of safety data from the two studies.
“The extensive safety database GTx is compiling from the numerous clinical studies of enobosarm will be a critical component of GTx's application for marketing approval, which we hope to submit following receipt of topline data from our Phase III clinical trials in the 3rd quarter of 2013.”
"We are pleased that the DSMB has recommended that GTx continue as planned with our clinical studies of enobosarm under the existing protocols," said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. "The extensive safety database GTx is compiling from the numerous clinical studies of enobosarm will be a critical component of GTx's application for marketing approval, which we hope to submit following receipt of topline data from our Phase III clinical trials in the 3rd quarter of 2013."
GTx has completed enrollment of approximately 650 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, Russia and South America. In each of the placebo-controlled, double-blind clinical trials, approximately 325 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 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. Topline data from the studies should be released during the third quarter of 2013.
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