Active Biotech and Ipsen have announced the recruitment of 600 patients in randomized, placebo-controlled Phase III study of tasquinimod in metastatic castrate-resistant prostate cancer patients.
The recruitment of half of target patient population triggered a €10m milestone payment from Ipsen to Active Biotech.
Ipsen chairman and chief executive officer Marc de Garidel said that Ipsen is now in the final stage of designing the randomized supportive study to be initiated before year-end and is getting ready to investigate tasquinimod in additional indications.
The study is designed to confirm tasquinimod’s efficacy on metastatic CRPC in the prechemotherapy setting, with radiological progression free survival as the primary endpoint and overall survival as secondary endpoint. The companies expect to report top line results by the end of 2013.