GTx presents quality of life results from Ostarine Phase IIb study in cancer cachexia patients at ASCO 2010

Jun 8 2010

GTx, Inc. (Nasdaq: GTXI) today presented additional results from the Ostarine™ Phase IIb study demonstrating an improvement in quality of life (fatigue and anorexia) in cancer patients with muscle wasting (cancer cachexia) who demonstrated improvement in functional performance as measured by stair climb. Ostarine (GTx-024) is GTx's lead selective androgen receptor modulator (SARM) which the company is developing for the treatment of cancer cachexia. The quality of life results (abstract #9147) were presented at the 2010 American Society of Clinical Oncology Annual Meeting.

"In three clinical trials in more than 380 patients, including this Phase IIb clinical trial in patients with cancer cachexia, Ostarine has demonstrated the ability to build muscle mass and improve functional performance," said Mitchell S. Steiner, MD, CEO of GTx. "We are encouraged that Ostarine has the potential to make a difference in a cancer patient's quality of life as measured by FACIT fatigue and FAACT anorexia scales."

The 16 week study evaluated Ostarine 1 mg and 3 mg compared to placebo in 159 cancer patients with non-small cell lung cancer, colorectal cancer, breast cancer, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma with cancer cachexia. Ostarine treatment resulted in a statistically significant increase in lean body mass and improvement in physical performance as measured by stair climb time and power.

In the study, improvements in stair climb speed or power (defined as a decrease in stair climb time greater than one second or an increase in power greater than 9.8 watts) also resulted in improvements in quality of life as measured by FAACT (Functional Assessment of Anorexia/Cachexia Treatment) and FACIT-F (Functional Assessment of Chronic Illness Treatment Fatigue) scales, as well as a separate FACIT-fatigue subscale.

Ostarine treated subjects were more likely than patients receiving placebo to demonstrate an improvement in stair climb time (58% compared to 22%, p<0.001) and stair climb power (47% compared to 31%).