GTx Inc. announced that FDA regulators will allow it to restart the clinical trials of its investigational prostate cancer drug Capesaris for men with castrate resistant advanced prostate cancer.
They anticipate that the trials of Capesaris will begin during the third quarter of 2012. The trial is designed to evaluate Capesaris as a secondary treatment for advanced prostate cancer that no longer responds to hormone treatment, a condition known as being castrate resistant.
The trial protocol will test three different doses of Capesaris on 75 men.
In February the he FDA ordered GTx to stop the clinical trials of Capesaris when GTx told the FDA that men who took the drug had an increased risk of developing blood clots. The company then stopped enrolling and treating men, and said it would test lower doses of Capesaris as a second treatment for prostate cancer.
So, look forward to these new trials for men who are castrate resistant.
Joel T Nowak, M.A., M.S.W.