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.