GTx's Phase III clinical studies of enobosarm to carry on as planned

GTx’s Phase III clinical studies of Enobosarm are to continue as planned following a recent safety review.

The company is to carry on with its two pivotal Phase III clinical trials of enobosarm, which aims to treat and prevent muscle wasting in patients with advanced non-small cell lung cancer.

An independent Data Safety Monitoring Board (DSMB) met every six months to analyse data from the two trials, and will meet again when the information is locked and unblinded for a final assessment.

GTx has carried out enrollment of around 650 subjects with advanced non-small cell lung cancer in the POWER 1 and POWER 2 trials.

These studies are carried out in clinical sites in the United States, Europe, Russia and South America, with around 325 patients with Stage III or IV non-small cell lung cancer have been randomised to oral daily doses of placebo or enobosarm 3mg when they begin first line standard chemotherapy.

Research is being evaluated at co-primary endpoints at three months of treatment, looking at the response rates of enobosarm versus placebo when it comes to maintaining or improving total lean body mass, which is being assessed by dual X-ray absorptiometry.

Mitchell Steiner, chief executive officer of GTx, said: “We are pleased that the DSMB has recommended that GTx continue as planned with our clinical studies of enobosarm under the existing protocols.

“The extensive safety database GTx is compiling from the numerous clinical studies of enobosarm will be a critical component of GTx’s application for marketing approval which we hope to submit following receipt of topline data from our Phase III clinical trials in the 3rd quarter of 2013.”

The drug’s durability is being analysed as a secondary endpoint at five months of treatment, with topline data expected to be released during 2013’s third quarter.

Posted by Fiona Griffiths