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.
Improved Physical Function is Associated with Increased Lean Body Mass (LBM): Findings From a Phase 2 Trial of the Selective Androgen Receptor Modulator (SARM) Enobosarm.This poster summarized the associations between changes in lean body mass and physical function in a Phase 2 enobosarm trial. Enobosarm has been evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess its effects on muscle wasting and physical function in patients with cancer. The Phase 2 trial enrolled 159 patients with NSCLC, colorectal cancer (CRC), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or breast cancer, who had not yet begun chemotherapy or were between chemotherapy cycles. The trial was designed to assess the effects of enobosarm on total LBM (muscle), with secondary objectives including assessments of the effects of enobosarm on total body weight, physical function, and quality of life. Total LBM assessed by DXA and physical function measured by the stair climb test (power) were assessed at baseline and Day 113/end of study. Key findings included:
- Patients with >0.25 kg gain in LBM were more likely to have a substantially meaningful response in physical function (62% versus 34%, p=0.017; Fisher’s Exact Test). These patients also had improvement in percentage change in stair climb power, median +12% versus +0.8% (p=0.017; Wilcoxon Rank Sum Test).
- This finding validates the value of these endpoints in the ongoing Phase 3 trials with enobosarm directed at preventing and treating muscle wasting in patients with cancer.