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Celsion Updates Status of SPA Submission

November 6, 2007

The FDA wants Celsion to clarify its comments regarding the company’s request for a special protocol assessment (SPA) for a Phase III study of ThermoDox in combination with radiofrequency ablation (RFA) compared with RFA alone in the treatment of nonresectable hepatocellular carcinoma.

The FDA requested clarifications to the study protocol and monitoring. Celsion will address all of the FDA’s comments and resubmit the protocol.

Michael Tardugno, Celsion’s president and CEO, said he does not expect to make significant changes to the trial design and hopes to begin the study early next year.