GTx, Inc. (NASDAQ: GTXI) announced today there will be two scientific poster presentations on the effects of enobosarm, a selective androgen receptor modulator (SARM), on improving physical function and quality of life in middle aged and elderly cancer patients. The posters will be displayed on October 26 th and 27 th, 2012, at the 12th Meeting of the International Society of Geriatric Oncology to be held at the Manchester Central Convention Centre in Manchester, United Kingdom. Ryan P. Taylor, PhD, GTx’s Associate Director of Medical Affairs, 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 and quality of life, regardless of baseline weight loss or age.
The first poster presentation will present data exploring patient response to treatment by grouping subjects according to their baseline weight loss (less or greater than 5% in the 6 month period prior to randomization), and the age of the patient (above and below the median age of 66 years). Of the 159 subjects randomized into the study, 103 had physical function (by stair climb test) assessed at both baseline and following 16 weeks of treatment and 24% of these subjects had lost less than 5% of weight. Significant improvement in physical function was observed in enobosarm treated subjects, while placebo subjects failed to improve, regardless of baseline weight loss or age.
The second poster presentation will present data indicating that patients, who responded to treatment during the enobosarm clinical study (>10% improvement in stair climb power), significantly increased three separate measures of quality of life, regardless of age. Quality of life questionnaires from 95 of the 159 subjects randomized into the study were analyzed to determine if there was an association between improvement in stair climb power (the physical function test assessed during the clinical study) and quality of life. Generally, a 5% increase in physical function from baseline is regarded as a minimal clinically meaningful change in physical function, while a 10% increase in physical function from baseline is thought to be a substantial clinically meaningful change. Subjects who showed improvements in stair climb power also were found to have improvements in quality of life, and subjects with the greatest stair climb improvement also had the greatest measured improvements in quality of life.