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February 24, 2014
08:07 EDTCLSNCelsion announces FDA clearance of the OPTIMA study
Celsion announced that the FDA has reviewed and provided clearance for the company's planned pivotal, double-blind, placebo-controlled Phase III trial of ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radio frequency ablation in primary liver cancer, also known as hepatocellular carcinoma. 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% 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.
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