GTx (Nasdaq: GTXI) takes hit with delay of Capesaris trials, greater net loss

Tallahassee, FL 2/21/12 (StreetBeat) -- Shortly after receiving news from the U.S. Food and Drug Administration that clinical trials for its Capesaris drug would be put on hold, Memphis-based pharmaceutical company GTx Inc. (Nasdaq: GTXI) reported a net loss of $10.7 million for the fourth quarter of 2011, compared to a loss of $7.5 million in the fourth quarter of 2010.

Capesaris, which is used to treat prostate cancer, was in its Phase II clinical trial, was put on hold after the company reported an increase in blood clots in subjects participating in the trial. The FDA announced the hold on Feb. 17, according to a GTx statement.

GTx reported revenue of $14.7 million for year end 2011, a 75 percent decline from $60.6 million the company reported at the end of 2010. However, the company’s revenue was $1.8 million in the fourth quarters of 2011 and 2010, based on sales of the company’s breast cancer drug Fareston.

Annual revenue included $6.7 million in sales for Fareston and collaboration revenue from the company’s previous partnership with French drug company Ipsen, which brought in revenue of $8.1 million.

GTx continues to develop Ostarine, a drug that is used to treat non-small cell lung cancer. The company changed the drug’s name to Enobosarm as it continues Phase III trials. GTx has received encouraging news from early results from the trials, but doesn’t expect to report full results until early 2013.

In late January, Citigroup Inc. (NYSE: C) reported the early results, which caused the company’s stock price to increase nearly 50 percent to $5.88. Shares of the company’s stock are trading down about 35 percent to $3.78 Tuesday morning.

In a statement, Mitchell Steiner, CEO of GTx, said the company is still exploring “a path forward” to continue to develop Capesaris at lower doses.”

“We plan to work with the agency to design appropriate studies for these patient populations,” Steiner said.

“We are pleased with the progress of our clinical development program of Enobosarm, formerly known as Ostarine,” 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.”

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