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news.Celsion has reported that two clinical sites are currently screening patients after receiving IRB approval for the Phase III study of ThermoDox in the treatment of non-resectable hepatocellular carcinoma.
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The trial is a randomized, double-blinded, dummy-controlled study designed to evaluate the efficacy and safety of ThermoDox in combination with radiofrequency ablation (RFA) compared to RFA-alone. This 40 center, 600-patient study is projected to enroll patients over approximately an 18 month period, and will conclude by fourth quarter of 2009.
In addition, the submission of Celsion’s clinical trial authorization application for the Phase III protocol has been accepted by China SFDA, with authorization to enroll patients expected in August 2008.