FDA Places Clinical Hold on GTx (GTXI) Capesaris Trials
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GTx, Inc. (Nasdaq: GTXI) said the FDA notified the Company in a telephone call on Friday, February 17, 2012, that the agency has placed a clinical hold on the Company’s clinical trials evaluating Capesaris® (GTx-758) for primary (first line) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal treatment. A clinical hold is a notification issued by the FDA to the trial sponsor to delay a clinical trial or suspend an ongoing clinical trial.
The clinical hold affects GTx’s Phase II loading dose finding clinical trial and its Phase IIb maintenance dose finding clinical trial, as well as its Phase II clinical trial in men with castration resistant prostate cancer. The clinical hold, which is effective immediately, follows the Company’s reports to the FDA of an increased risk of venous thromboembolic events, or blood clots, in subjects treated with Capesaris at the doses studied (1000 mg and higher) and the Company’s request to discuss changes in its clinical development program. GTx has suspended further enrollment into these studies and has notified clinical sites to discontinue treatment of subjects.
The Company believes there may be a path forward to develop Capesaris at lower doses to treat men with metastatic hormone sensitive prostate cancer or castration resistant prostate cancer. The Company will work with the FDA to determine the appropriate course of action to evaluate Capesaris in these patient populations.
The clinical hold affects GTx’s Phase II loading dose finding clinical trial and its Phase IIb maintenance dose finding clinical trial, as well as its Phase II clinical trial in men with castration resistant prostate cancer. The clinical hold, which is effective immediately, follows the Company’s reports to the FDA of an increased risk of venous thromboembolic events, or blood clots, in subjects treated with Capesaris at the doses studied (1000 mg and higher) and the Company’s request to discuss changes in its clinical development program. GTx has suspended further enrollment into these studies and has notified clinical sites to discontinue treatment of subjects.
The Company believes there may be a path forward to develop Capesaris at lower doses to treat men with metastatic hormone sensitive prostate cancer or castration resistant prostate cancer. The Company will work with the FDA to determine the appropriate course of action to evaluate Capesaris in these patient populations.
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