GTx stock takes a pounding as FDA puts clinical hold on Capesaris trial

Tennessee, USA-based  GTx (Nasdaq: GTXI) saw its shares plunge 30% to $3.98 earlier this week, after the company revealed that US Food and Drug Administration had notified it via a telephone call on Friday (February 17), that the agency has placed a clinical hold on the firm’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’ 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.

GTx 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, saying it will work with the FDA to determine the appropriate course of action to evaluate Capesaris in these patient populations.