Celsion is down 4% after the company provided an update to its Phase III OPTIMA program for ThermoDox, also known as hepatocellular carcinoma (HCC).
The Phase III OPTIMA study is expected to enroll up to 550 patients at up to 75 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone
It said it recently met with the China Food and Drug Administration (CFDA) to discuss the ongoing Phase 3 OPTIMA program and regulatory pathway for ThermoDox in China. The CFDA informed Celsion that if the ongoing Phase 3 OPTIMA trial is successful, the trial could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or European Union which is currently required for foreign company application. This would allow the company to accelerate its plans for a regulatory filing in China and, if approved, provide for a significantly earlier launch date in China than originally expected, it said.