MEMPHIS, Tenn.--()--GTx, Inc. (Nasdaq: GTXI) today announced that a per protocol interim safety review on Friday, October 26, 2012, by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. The DSMB meets every six months to review safety data from the two pivotal Phase III clinical trials, POWER 1 and POWER 2.
“The extensive safety database GTx is compiling from approximately 9 clinical studies of enobosarm will be a critical component of the application for marketing approval we hope to submit following receipt of topline data from our Phase III clinical trials in the 2nd quarter of 2013.”
“The DSMB reviewed safety data from the subjects enrolled in our two pivotal Phase III clinical trials and recommended that GTx continue with the trials as planned,” said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. “The extensive safety database GTx is compiling from approximately 9 clinical studies of enobosarm will be a critical component of the application for marketing approval we hope to submit following receipt of topline data from our Phase III clinical trials in the 2nd quarter of 2013.”
GTx is currently enrolling subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III studies are being conducted in clinical sites in the United States, Europe, and South America. In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm 3 mg at the time they begin first line standard chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment. Enrollment for both studies is expected to be completed in the fourth quarter of this year, and topline results should be released during the second quarter of 2013.
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 quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2012 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.