COLUMBIA, Md., Dec 10, 2007 (BUSINESS WIRE) -- CLN charts news PowerRating -- CELSION CORPORATION (AMEX: CLN charts news PowerRating) today announced it has re-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 submission maintains the previously proposed global trial design, with clarifications requested by the FDA. The Phase III trial will continue to be a randomized, double-blinded trial, and 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.
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Monday, December 10, 2007
Celsion Re-Submits Protocol for Special Protocol Assessment (SPA) for Pivotal Phase III Liver Cancer Trial
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