GTx's Phase-II Cancer Cachexia Trial Meets Primary Endpoint

Published: 11-Jun-2009

Ostarine enhanced lean body mass and muscle performance

GTx has declared results of a Phase II clinical trial evaluating Ostarine, an investigational selective androgen receptor modulator (SARM), in patients with cancer induced muscle loss, also known as cancer cachexia.

In the study, Ostarine led to significant increase in lean body mass (LBM) and improvement in muscle performance measured by stair climb in patients with cancer cachexia, as compared to baseline in both the Ostarine 1mg and 3mg treatment cohorts.

Ostarine met the primary endpoint of LBM, demonstrating statistically significant increases in LBM compared to baseline in both the Ostarine 1mg and 3mg treatment cohorts. Specifically, the change from baseline in LBM for the placebo, 1mg and 3mg treatment groups was 0.1 kg (p=0.874 compared to baseline), 1.5 kg (p=0.001) and 1.3 kg (p=0.045), respectively, at the end of the 16-week trial.

Mitchell Steiner, CEO of GTx, said: “We are encouraged by results of this Phase II trial in patients with cancer cachexia, where Ostarine showed significant improvements in lean body mass in both treatment cohorts.”

“We look forward to our continued partnership with Merck on the SARM program, and to evaluating the full potential of our lead product candidate Ostarine in conditions such as cancer cachexia, sarcopenia, and other muscle wasting conditions,” he added.

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