Celsion: intermediate review of Phase III ThermoDox HEAT study completed

theflyonthewall.com

Celsion announced that the independent Data Monitoring Committee, or DMC, for the company's HEAT Study, a fully enrolled, multinational, double-blind, placebo-controlled, pivotal Phase III trial of ThermoDox in combination with radiofrequency ablation, or RFA, for hepatocellular carcinoma, or HCC or primary liver cancer, has completed a regularly scheduled review of all 701 patients enrolled in the trial and has unanimously recommended that the HEAT Study continue according to protocol to its final data readout. The HEAT Study is being conducted under a Special Protocol Assessment, or SPA, agreed to with the U.S. FDA.

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