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Celsion Says FDA Clears Planned OPTIMA Study

Celsion Corp. (CLSN) Monday said the U.S. Food and Drug Administration has reviewed and provided clearance for the company's planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox in combination with radio frequency ablation or RFA in primary liver cancer, also known as hepatocellular carcinoma or HCC.

The trial design is based on a comprehensive analysis of data from the company's Phase III HEAT Study, which demonstrated that treatment with ThermoDox resulted in a 55 percent improvement in overall survival in a substantial number of HCC patients that received an optimized RFA treatment. Celsion expects to launch the study in the first half of 2014.

The Phase III trial, known as the OPTIMA Study, is expected to enroll 550 patients globally, with up to 100 sites in the U.S., Europe, China and Asia Pacific.

It will evaluate ThermoDox in combination with RFA, which will be standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival.

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