FDA withdraws hold on GTx’s prostate cancer drug

Posted under Blog, Cancer Drugs, Clinical Trials, Companies, Diagnostics, FDA, Funding, GTx, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Prostate Cancer, Regulatory, Startups, Universities, Videos by rmcbride

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

Related Article:
GTx shares tumble after clot threat forces hold on prostate cancer drug

GTx shares tumble after clot threat forces hold on prostate cancer drug

Posted under Blog, blood clots, Companies, Diagnostics, Funding, GTx, Medical Devices, Medical Supply, non-small cell lung cancer, Pharmaceuticals, Prostate Cancer, Startups, Universities, Videos by John Carroll

Shares of GTx tumbled early today after the biotech revealed that it had been forced to shutter a trio of clinical trials for its prostate cancer drug hopeful Capesaris after investigators spotted an elevated risk for blood clots among the patients taking the drug. GTx stock ($GTXI) plunged 31% as investors fled on hearing that the FDA had put a clinical hold on its mid-stage studies, throwing up a critical roadblock to its plan to pursue an approval as a frontline treatment.

Memphis-based GTx says its next step will be to sound out the FDA on a change in clinical direction for the treatment, and management raised the possibility of pursuing a lower-dose approach to metastatic hormone sensitive prostate cancer or castration-resistant prostate cancer. In the meantime, GTx CEO Mitchell Steiner resorted to a familiar tactic in the face of clinical adversity: He highlighted the potential of another development program.

"We are pleased with the progress of our clinical development program of enobosarm (the late-stage GTx-024), formerly known as Ostarine," Dr. Steiner said. "Our discussions with lung cancer thought leaders and patient advocates confirm the need for a drug to prevent and treat muscle wasting in patients with advanced non-small cell lung cancer."

GTx--which had benefited from a 73% spike since the beginning of 2012--also reported this morning that the company had lost 17 cents a share in the fourth quarter, in line with Wall Street estimates, according to Dow Jones.

- here's the press release
- get the story from Dow Jones