GTx to Present on Enobosarm for Muscle Wasting in Non-Small Cell Lung Cancer at an Industry Expert T
GTx to Present on Enobosarm for Muscle Wasting inNon-Small Cell Lung Cancer at an Industry Expert Theater During the 2013 ASCO Annual Meeting
MEMPHIS, Tenn.--(BUSINESS WIRE)-- GTx, Inc. (NAS: GTXI) announced today that the company will showcase the development of enobosarm at an Industry Expert Theater Presentation on Sunday, June 2nd from 9:45am-10:45am during the upcoming 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Mitchell Steiner, MD, FACS, GTx's Chief Executive Officer, will host a presentation entitled the Development of Enobosarm (Selective Androgen Receptor Modulator) for the prevention and treatment of muscle wasting in non-small cell lung cancer (NSCLC) patients. Dr. Steiner's presentation will review the enobosarm clinical program, from discovery through phase 3 clinical development, including an update on the baseline demographics of the two completely enrolled Phase 3 clinical trials, POWER 1 and POWER 2.
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 NSCLC. In each of these placebo-controlled, double-blind clinical trials, approximately 325 patients with stage III or IV NSCLC have been randomized to oral daily doses of enobosarm 3mg 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 (muscle) assessed by dual-energy X-ray absorptiometry (DXA) and physical function measured by the stair climb test (power). GTx announced earlier this year that the U.S. Food and Drug Administration has designated enobosarm for the prevention and treatment of muscle wasting in patients with NSCLC as a Fast Track development program.
"I am excited to have the opportunity to share the history and clinical development path for enobosarm, which represents 15 years of hard work, commitment and dedication on behalf of GTx. Enobosarm is a first in class compound that may enhance overall care of patients with NSCLC by improving physical function, morbidity and mortality," stated Dr. Mitchell Steiner.
In addition to the POWER Trials, GTx will be highlighting at the 2013 ASCO Annual Meeting their current clinical Phase 2 programs with enobosarm 9mg in estrogen receptor positive and androgen receptor positive metastatic breast cancer and GTx-758 for the treatment of advanced prostate cancer at Exhibit Booth #10097.
GTx has two on-line abstracts featured at ASCO. The first abstract entitled, "Baseline characteristics from two ongoing phase III trials for the prevention and treatment of muscle wasting in NSCLC" (abstract e19100). The second abstract is entitled, "The free hormone hypothesis: Correlation of decreases in PSA with free testosterone rather than total testosterone in men with advanced prostate cancer treated with GTx-758" (abstract e16015). Both of these abstracts will be available for discussion at the GTx Exhibit Booth.
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 GTx's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTx's clinical trials for enobosarm (also known as Ostarine®or GTx-024). GTx'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. GTx's annual report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2013 contains under the heading, "Risk Factors," 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.
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