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VOL. 127 | NO. 36 | Wednesday, February 22, 2012

FDA Places Hold on GTx Study as Company Reports Earnings Drop

By Aisling Maki

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Memphis-based pharmaceutical company GTx Inc. on Tuesday, Feb. 21, announced that the U.S. Food and Drug Administration had placed a clinical hold on the company’s Phase II clinical studies for Capesaris.

The drug was being evaluated as a primary androgen-deprivation therapy for advanced prostate cancer and secondary hormonal treatment.

The hold came after the company updated the FDA about blood clots that had been reported over the prior several weeks in patients who had received high doses of Capesaris in one of the clinical trials.

“And after looking at the data, they requested that we suspend the studies,” said McDavid Stilwell, GTx director of corporate communications. “So right now we’re waiting to get a written communication from them regarding what steps we need to take in order to restart clinical development.”

The company believes there may still be a path forward to develop Capesaris at lower doses to treat men with metastatic hormone-sensitive prostate cancer or castration-resistant prostate cancer, who want to select a secondary hormonal therapy before moving to chemotherapy.

GTx CEO Dr. Mitchell S. Steiner says the company plans to work with the FDA to design appropriate studies for those patient populations.

The announcement came on the same day GTx reported its earnings for the fourth quarter, which ended Dec. 31. The company’s net loss was $10.7 million compared to a net loss of $7.5 million for the same period in 2010, reflecting increased research and development costs in connection with the company’s clinical development programs for Capesaris and another drug called Ostarine (enobosarm).

“When you look at our income statements, you’ve got to remember that our business is investing in research and development.”

 –McDavid Stilwell

GTx director of corporate communications


The company’s net loss for the full-year 2011 was $33.3 million compared to net income of $15.3 million for the full-year 2010.

Revenue for Q4 totaled $1.8 million and consisted of net sales of Fareston 60 mg, approved for the treatment of metastatic breast cancer in postmenopausal women.

Full-year 2011 revenue was $14.7 million compared to full-year 2010 revenue of $60.6 million, which, in addition to Fareston net sales, included collaboration revenue from a company called Ipsen after the termination of that agreement.

Research and development expenses for the quarter and year ended Dec. 31 were $8.9 million and $31.9 million, respectively, compared to $5.8 million and $28.5 million for the same periods in 2010.

“When you look at our income statements, you’ve got to remember that our business is investing in research and development,” Stilwell said. “The R&D expenses ticked up some in the more recent quarter, both compared to a year ago and compared to the prior quarter, and that was simply a function of running more clinical trials and more patients initiating clinical trials.”

General and administrative expenses for the quarter and 2011 were $3.4 million and $15.4 million, respectively, compared to $4.5 million and $17.4 million for the same periods in 2010.

As of Dec. 31, GTx had cash, cash equivalents and short-term investments of $74.4 million.

The company is now enrolling for two pivotal Phase III clinical trials of Ostarine – generic name enobosarm – a drug for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

GTx recently commenced the trials, called POWER1 and POWER2, in patients with advanced non-small cell lung cancer. The studies are being conducted at clinical sites in the United States, Europe and South America.

“Those two studies, POWER1 and POWER2, are in the process of enrolling,” Stilwell said. “We’re going to have 600 patients combined, and we expect to have the studies enrolled this summer. Then we would have data back from those studies in the first quarter of 2013.”

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