Memphis, Tennessee-based biopharmaceutical company GTx Inc. (GTXI) said Tuesday that the U.S. FDA has placed a clinical hold on its phase II trials evaluating Capesaris for first line treatment of advanced prostate cancer and secondary hormonal therapy. The company also reported a wider loss for the last quarter of the year, hurt by higher R&D costs relating to its enobosarm and Capesaris clinical development programs. In the pre-market hours, shares are down more than 30%, trading at $3.98.
The regulatory agency notified GTx about the clinical hold in a telephonic call on February 17, following the company's request to discuss changes in its clinical development program because of dose related safety involving venous thromboembolic events at the doses studied 1000 mg and higher.
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 company said it will work with the FDA to determine the path forward for evaluating Capesaris in men with metastatic hormone sensitive prostate cancer or castration resistant prostate cancer.
The company posted fourth-quarter net loss of $10.7 million, wider than last year's $7.5 million. While revenues stood at $1.8 million, Research and development costs rose to $8.9 million from $5.8 million.
GTx generated revenues of $1.5 million from sales of FARESTON 60 mg, approved for the treatment of metastatic breast cancer in postmenopausal women, and $336 thousand from former collaboration with Ipsen Biopharm Limited.
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