MEMPHIS, TN, USA I September 24, 2013 I GTx, Inc. (GTXI) announced today that top line results from the two Phase 3 trials (POWER1 and POWER2) on the effects of enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer patients will be presented on September 28, 2013, at the European Cancer Congress 2013 (September 27-October 1, 2013) in Amsterdam.
Jeffrey Crawford, M.D., Chief, Division of Medical Oncology at Duke University School of Medicine, and principal investigator for the POWER1 and POWER2 clinical studies will present the results on September 28th, 2013 at 1:39PM (Elicium 2) during the Proffered Papers Session: Lung Cancer – Localised and Metastatic (11:00-14:00).
The abstract number is LBA 21: Results from two Phase 3 randomized trials of enobosarm, selective androgen receptor modulator (SARM), for the prevention and treatment of muscle wasting in NSCLC.
About The POWER Trials
A 3 mg dose of enobosarm was studied in two Phase 3 clinical trials to prevent and treat muscle wasting in patients with NSCLC. In each of these placebo controlled, double blind clinical trials, approximately 325 patients with stage III or IV NSCLC were randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first-line standard platinum doublet chemotherapy. The POWER trials were designed to assess the response rates of enobosarm versus placebo for the co-primary endpoints at 3 months of treatment on maintenance or improvement of total lean body mass (muscle) assessed by Dual-energy X-ray Absorptiometry (DXA) and improvement in physical function measured by the stair climb test (power). Durability of enobosarm treatment was assessed at five months. Secondary endpoints included an assessment of whether enobosarm-treated patients had an improved quality of life and reduced healthcare resource utilization compared to placebo. Overall survival is being assessed as an additional safety endpoint. GTx announced earlier this year that the FDA has designated enobosarm for the prevention and treatment of muscle wasting in patients with NSCLC as a Fast Track development program.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules for the treatment of cancer, cancer supportive care, and other serious medical conditions.
SOURCE: GTx
Post Views: 65
MEMPHIS, TN, USA I September 24, 2013 I GTx, Inc. (GTXI) announced today that top line results from the two Phase 3 trials (POWER1 and POWER2) on the effects of enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer patients will be presented on September 28, 2013, at the European Cancer Congress 2013 (September 27-October 1, 2013) in Amsterdam.
Jeffrey Crawford, M.D., Chief, Division of Medical Oncology at Duke University School of Medicine, and principal investigator for the POWER1 and POWER2 clinical studies will present the results on September 28th, 2013 at 1:39PM (Elicium 2) during the Proffered Papers Session: Lung Cancer – Localised and Metastatic (11:00-14:00).
The abstract number is LBA 21: Results from two Phase 3 randomized trials of enobosarm, selective androgen receptor modulator (SARM), for the prevention and treatment of muscle wasting in NSCLC.
About The POWER Trials
A 3 mg dose of enobosarm was studied in two Phase 3 clinical trials to prevent and treat muscle wasting in patients with NSCLC. In each of these placebo controlled, double blind clinical trials, approximately 325 patients with stage III or IV NSCLC were randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first-line standard platinum doublet chemotherapy. The POWER trials were designed to assess the response rates of enobosarm versus placebo for the co-primary endpoints at 3 months of treatment on maintenance or improvement of total lean body mass (muscle) assessed by Dual-energy X-ray Absorptiometry (DXA) and improvement in physical function measured by the stair climb test (power). Durability of enobosarm treatment was assessed at five months. Secondary endpoints included an assessment of whether enobosarm-treated patients had an improved quality of life and reduced healthcare resource utilization compared to placebo. Overall survival is being assessed as an additional safety endpoint. GTx announced earlier this year that the FDA has designated enobosarm for the prevention and treatment of muscle wasting in patients with NSCLC as a Fast Track development program.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules for the treatment of cancer, cancer supportive care, and other serious medical conditions.
SOURCE: GTx
Post Views: 65
