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May 21, 2014
08:03 EDTCLSNCelsion announces regulatory cleraance to initiate Phase III study of Thermodox
Celsion announced it has received regulatory clearance to initiate its Phase III OPTIMA Study at clinical trial sites in Taiwan, Hong Kong, South Korea and Canada. The OPTIMA Study is the company's planned global pivotal, double-blind, placebo-controlled study evaluating ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation, in primary liver cancer, also known as hepatocellular carcinoma. In addition, the company continues to advance its global regulatory strategy and has filed Clinical Trial Applications in the Philippines and Thailand, as well as a request for a Voluntary Harmonization Procedure in Europe, which provides for the assessment of multinational clinical trial applications across several European countries, including Germany, France and Spain. As previously reported, the company has submitted an Application for Accelerated Trial Approval to the China Food and Drug Administration. The Company also plans to expand its clinical site footprint in Europe and will meet with the European Medicines Agency during 2014 to discuss ThermoDox trial design and registrational strategy.
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