The three-month placebo-controlled clinical trial, which GTx initiated in May, is evaluating multiple doses of ostarine in 60 elderly men and 60 postmenopausal women. It is designed to evaluate the activity of ostarine on building muscle and promoting bone, as well as to assess safety in both elderly men and postmenopausal women.
GTx expects to report data from the phase II clinical trial in the fourth quarter of 2006. Based on ostarine’s phase II clinical data profile, GTx will select specific acute and chronic bone and/or muscle wasting diseases for further development.
“We are pleased to announce the successful enrollment of our ostarine proof of concept trial,” said Dr Mitchell Steiner, CEO of GTx. “The trial is designed to give us comprehensive clinical information on ostarine that will be critical to the design of phase IIb and phase III clinical trials.”
GTx plans to initiate a phase IIb or phase III clinical trial in the first half of 2007.