Ipsen and Active Biotech announced the initiation of a new phase II proof of concept clinical trial, evaluating the activity of tasquinimod in advance metastatic castrate resistant prostate cancer patients. The study aims at establishing the clinical efficacy of tasquinimod used as maintenance therapy in patients with metastatic castrate-resistant prostate cancer who have not progressed after a first line docetaxel based chemotherapy. The "switch maintenance" trial is part of the initial agreement with Active Biotech to enhance tasquinimod's data package beyond the ongoing phase III placebo-controlled study in men with bone-metastatic CRPC, which has been adequately powered to detect an OS improvement. The phase III study will include about 1,200 patients in more than 250 centers. Recruitment is proceeding according to plan with top line results expected by the end of 2013, the company said.
- Pharmaceuticals & Drug Trials