COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX:CLN) today announced it has filed for a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of ThermoDox™ (Thermally Sensitive Liposomal Doxorubicin) in combination with radiofrequency ablation (RFA) to treat patients with non-resectable Hepatocellular Carcinoma (HCC). The Phase III trial, a randomized, double-blinded study, will examine the efficacy and safety of ThermoDox plus RFA versus RFA-alone. As proposed, the global trial is expected to enroll and randomize approximately 600 patients.
