GTx StartsTrial for Cancer Drug

[Christine]

http://www.pharmaceutical-business-revi ... 6564ED6DED

GTx Inc has initiated a phase IIb trial evaluating Ostarine for the treatment of cancer cachexia, a muscle wasting condition.

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.

[RandyW]

there are several trials that are recruiting right now and one that has not yet started to recruit. Cachexia is of course the part of this disease that we all deal with when we can not get weiight up and getting people to eat properly. This is what we fight against by getting people to eat and when they do not, this is the result CACHEXIA!!!!!!! For a list of other trials on cachexia click below to be redirected;

http://clinicaltrials.gov/ct/search;jse ... exia+trial