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FDA lifts clinical hold on GTx's trials of Capesaris in advanced prostate cancer

Tuesday, May 08 2012 | Comments
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The Food and Drug Administration removed its full clinical hold on GTx Inc.'s Investigational New Drug (IND) application for Capesaris, a selective estrogen receptor alpha agonist that GTx is developing as a treatment for advanced prostate cancer. The FDA issued the hold on clinical trials of the drug in February after GTx reported an increased risk of venous thromboembolic events in study participants who were treated with Capesaris at the doses studied (1,000 mg or higher) and after the...

The Food and Drug Administration removed its full clinical hold on GTx Inc.'s Investigational New Drug (IND) application for Capesaris, a selective estrogen receptor alpha agonist that GTx is developing as a treatment for advanced prostate cancer.

The FDA issued the hold on clinical trials of the drug in February after GTx reported an increased risk of venous thromboembolic events in study participants who were treated with Capesaris at the doses studied (1,000 mg or higher) and after the company requested a discussion about changes in its clinical development program for the drug. Before the hold was issued, GTx had been evaluating Capesaris as a first-line androgen-deprivation therapy for advanced prostate cancer and as second-line hormonal treatment.

After the regulatory agency issued the hold, GTx suspended further enrollment in the trials and discontinued treatment. At the time, the company said it believed there could be "a path forward" to develop Capesaris at lower doses as a treatment for men with metastatic hormone-sensitive prostate cancer or castration-resistant prostate cancer, adding that it would work with the FDA to determine the appropriate course of action to evaluate the drug in those patient populations.

In April, GTx submitted a complete response to the FDA, which the firm said addressed the safety issue observed in clinical trials and included development plans for Capesaris as a second-line hormonal therapy for advanced prostate cancer at lower doses than those previously tested.

The FDA removed the clinical hold on the company's IND after reviewing the firm's complete response and the new Phase II protocol.

The Phase II trial outlined in the protocol is expected to begin later this year. It will include 75 men with metastatic, castration-resistant prostate cancer and will test three lower doses of the drug (125 mg, 250 mg and 500 mg) sequentially in cohorts of 25 patients each.

The trial will assess the safety and efficacy of Capesaris as secondary hormonal therapy in men who are receiving maintenance treatment with primary androgen-deprivation therapy. The assessment of safety will include an evaluation of venous thromboembolic events, the firm noted.

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