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GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported financial results for the fourth quarter and full year 2012.
“We have completed enrollment of our two pivotal Phase III clinical trials evaluating enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer patients,” said Mitchell S. Steiner, MD, CEO of GTx. “We are pleased that FDA has recognized enobosarm as a potentially important new drug product to address the serious and unmet medical need of muscle wasting in this lung cancer population by recently granting enobosarm fast track designation.”
Clinical updatesEnobosarm (Ostarine®, GTx-024), an oral selective androgen receptor modulator, being studied for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer: GTx completed enrollment in late December of 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 approximately 80 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 began first line standard platinum doublet 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 will be evaluated as a secondary endpoint at five months of treatment. Topline results will be presented for both studies at the same time in the third quarter of this year and will include the co-primary endpoints and safety assessments, as well as an update on survival.
In January, GTx announced that the FDA has designated enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer as a fast track development program. Fast track status is a process designed by the FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a fast track designation, there is an increased possibility for a priority review of a new drug application (NDA) filed for the drug candidate and the opportunity for more frequent interactions with the FDA both prior to and following the filing of a NDA.