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GTx, Inc. (Nasdaq: GTXI) announced today that the Company showcased two scientific poster presentations on enobosarm, a selective androgen receptor modulator (SARM), for the prevention and treatment of muscle wasting in cancer patients during the 2013 MASCC/ISOO International Symposium on Supportive Care in Cancer being held at the InterContinental Convention Centre in Berlin, Germany, June 27-29, 2013.
Poster presentations that took place at 9:30 Central European time this morning
at MASCC/ISOO include the following:
Randomized Trials in NSCLC Investigating the Selective Androgen Receptor Modulator (SARM) Enobosarm to Prevent and Treat Muscle Wasting: Feasibility and Characteristics of Patients at Baseline
This poster outlined the baseline characteristics of the patients in the POWER trials as well as the design of the trials.
Enobosarm is currently being evaluated in two Phase 3 clinical trials, POWER 1 and POWER 2, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC). In each of these placebo-controlled, double-blind clinical trials, approximately 325 patients with stage III or IV NSCLC have been randomized to receive oral daily doses of enobosarm 3 mg or placebo at the time they began first-line standard platinum doublet chemotherapy. The POWER trials are designed to assess the response rates of enobosarm versus placebo for the co-primary endpoints at three months of treatment on total lean body mass (LBM) assessed by dual-energy X-ray absorptiometry (DXA) and physical function measured by the stair climb test (power).
Baseline characteristics included:
Median weight-loss at baseline was 5%.
LBM and stair climb power were lower than typically observed in healthy individuals indicating significant functional decline before starting chemotherapy for NSCLC.
Majority of patients presented with stage IV NSCLC.
Most patients were ECOG 1.
The Company plans to release topline data from the two pivotal Phase 3 clinical trials for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer in 3Q 2013.