PharmaMar (MSE:PHM) announced today that the Independent Data Monitoring Committee (IDMC) has notified the Company of its recommendation that the Phase III (CORAIL) trial currently under way with PM1183 in platinum-resistant ovarian cancer patients should continue without any changes.
The IDMC's recommendation came after an analysis of the safety data obtained with the first 80 patients treated in the trial. This pivotal randomised Phase III trial assesses the efficacy of PM1183 compared with the standard treatment for this indication -- topotecan or pegylated liposomal doxorubicin -- in a total of 420 patients.
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