FDA withdraws hold on GTx's prostate cancer drug

GTx ($GTXI) is back on track to begin a mid-stage study of its drug Capesaris. The FDA lifted a clinical hold on the experimental cancer drug after reviewing the company's response and plans for a Phase II study involving patients with castration-resistant prostate cancer.  

Memphis-based GTx now aims to launch the mid-stage trial in the third quarter, testing the drug in 75 men at three lower doses, the company said today. The study aims to measure safety and efficacy of the hormone therapy in men with aggressive prostate cancers.

U.S. regulators placed the program on hold in February after GTx revealed to the agency an increased risk of clotting. The safety risk was seen in patients treated with higher doses of the drug than the company plans to test in the revamped Phase II trial. The upbeat development pushed the company's stock price up nearly 20% to $3.72 this morning, helping the price regain some lost ground since the clinical hold made news.

GTx also said today in a corporate update that the company is enrolling patients for two late-stage studies of Ostarine for combating muscle wasting in patients with advanced non-small cell lung cancer. The update included results for the first quarter, which said that the company had $64 million in cash equivalents and other short-term investments as of March 31.

- here's the release on Capesaris
- see Reuters' update