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news.Celsion Corporation has re-filed for a special protocol assessment with the FDA for the design of its Phase III trial of ThermoDox in combination with radiofrequency ablation to treat patients with non-resectable hepatocellular carcinoma.
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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 (thermally sensitive liposomal doxorubicin) plus radiofrequency ablation (RFA) versus RFA-alone. As proposed, the global trial is expected to enroll and randomize approximately 600 patients.
Michael Tardugno, Celsion’s president and CEO, said: “These clarifications on the Phase III protocol have improved the design efficiency of the trial. Celsion appreciates the collaborative manner in which the FDA is working with Celsion in an effort to reach complete agreement. We are confident with this submission and anticipate commencing the trial in the first quarter of 2008 upon special protocol assessment (SPA) approval. As reported previously, Celsion has been aggressively working in parallel to plan startup operational activities with the intention that overall global timelines are not delayed.”