GTXI -
GTx Announces Late Breaker Presentation on Results from the two Phase 3 POWER Trials of enobosarm, a selective androgen recep...
GTx, Inc. (Nasdaq: 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.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTxâ??s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTxâ??s clinical trials for enobosarm (also known as Ostarine® or GTx-024). GTxâ??s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials being conducted by GTx may not be completed on schedule, or at all, or may otherwise be suspended or terminated; or (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTxâ??s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on July 22, 2013 contains under the heading, â??Risk Factors,â? a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
GTx Announces Late Breaker Presentation on Results from the two Phase 3 POWER Trials of enobosarm, a selective androgen recep...
GTx, Inc. (Nasdaq: 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.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTxâ??s current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTxâ??s clinical trials for enobosarm (also known as Ostarine® or GTx-024). GTxâ??s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials being conducted by GTx may not be completed on schedule, or at all, or may otherwise be suspended or terminated; or (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTxâ??s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on July 22, 2013 contains under the heading, â??Risk Factors,â? a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
