GTx starts trial for cancer drug

The phase IIb cancer cachexia trial is a randomized, double blind, placebo controlled study of muscle wasting in 150 patients with non-small cell lung cancer, colorectal cancer, non-Hodgkin’s lymphoma, or chronic lymphocytic leukemia. The study is being conducted at approximately 35 clinical sites in the US and Argentina.

Participants are being randomized to receive placebo, Ostarine 1mg, or Ostarine 3mg for four months. The primary endpoint of the trial is the change in total lean body mass (muscle) at 16 weeks. Secondary endpoints include functional performance and safety.

Memphis-based GTx said that it expects to report top line data in the summer of 2008.

“We are pleased to initiate the Ostarine phase IIb cancer cachexia clinical trial on schedule,” said Mitchell Steiner, CEO of GTx. “Cancer cachexia, as a large unmet medical need, is an important first indication for the late-stage development of Ostarine.”

Cachexia is a debilitating, progressive muscle wasting condition manifested by unintentional weight loss, muscle weakness, anemia, fatigue, and death. More than 50% of cancer patients present with or subsequently develop cachexia, which is associated with a poor prognosis and can adversely affect a patient’s quality of life. There are no drugs approved by the FDA for the treatment of cancer cachexia.