GTx is conducting two pivotal Phase III clinical trials (POWER 1 and POWER 2) in the United States, Europe and South America, evaluating a once daily 3 mg dose of enobosarm for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. More information about these two clinical studies can be found at www.gtxclinicaltrials.com.About GTx GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules that selectively target hormone pathways 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 its planned clinical trials. 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 10, 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.
GTx, Inc. (Nasdaq: GTXI) announced today there will be two scientific presentations on the effects of enobosarm, a selective androgen receptor modulator (SARM), on improving physical function in cancer patients on June 30, 2012, between 2:30 and 4:00pm eastern daylight time, at the MASCC/ISOO 2012 International Symposium held at the Hilton New York Hotel in New York, New York. James T. Dalton, PhD., VP, Chief Scientific Officer of GTx, will present data from the company’s Phase IIb clinical study of enobosarm providing evidence that enobosarm may play an important role in the management of cancer patients with muscle wasting by improving physical function. Of the 159 subjects randomized into the study, 103 had physical function (stair climb) assessed at both baseline and following 16 weeks of treatment. 24% of these subjects had lost less than 5% of weight. Distribution of weight loss was similar across genders; however, subjects with less than 5% weight loss were more likely to have a normal performance status (ECOG=0), while subjects with 5% or more weight loss at baseline demonstrated a comparatively worse performance status. Significant improvement in physical function was observed in enobosarm treated subjects, regardless of baseline weight loss, while placebo subjects failed to improve. Mitchell S. Steiner, MD, CEO of GTx, will present data indicating that enobosarm may positively impact the management of cancer-related muscle wasting. In GTx’s Phase IIb enobosarm clinical study, lower baseline testosterone levels correlated with greater baseline weight loss;.hypogonadal male subjects had greater weight loss than eugonadal males. Baseline physical function (stair climb power) of subjects in the study was higher among eugonadal versus hypogonadal males. After 16 weeks of treatment, enobosarm significantly improved physical function in both hypogonadal and eugonadal subjects compared to placebo. Enobosarm is a SARM which binds to the androgen receptor and is designed to deliver the beneficial effects of androgens while minimizing unwanted clinical side effects. GTx conducted its Phase IIb clinical study of enobosarm in 159 cancer patients (average age of 66 years) in 35 sites in the United States and Argentina. Participants were randomized to receive placebo, 1 mg or 3 mg oral tablet of enobosarm once daily for 16 weeks. Average reported weight loss prior to entry among all subjects was 8.8%, and subjects were allowed to have standard chemotherapy during the trial. The drop-out rate during the trial was 33%. The study met its primary endpoint of absolute change in total lean body mass (muscle) compared to placebo after 16 weeks of treatment.