Celsion Resubmits Protocol for SPA

Celsion has refiled for a special protocol assessment (SPA) with the FDA for the design of its Phase III trial of ThermoDox in combination with radio frequency ablation (RFA) to treat patients with nonresectable hepatocellular carcinoma.

ThermoDox is the company’s heat-sensitive liposomal encapsulation of doxorubicin, an approved anticancer drug used to treat various cancers.

The randomized, double-blind trial will enroll approximately 600 patients and examine the efficacy and safety of ThermoDox plus RFA versus RFA alone, Celsion said.