Oncology drug developer Celsion has won clinical trial approval from the China Food and Drug Administration to conduct an ongoing phase III study evaluating ThermoDox at clinical sites in China.
ThermoDox is a heat-activated liposomal encapsulation of doxorubicin. The OPTIMA study is assessing ThermoDox's performance in combination with radiofrequency ablation standardized to 45 minutes versus radiofrequency ablation alone for treating patients with primary liver cancer.
The study is expected to enroll up to 550 patients around the world, and it currently includes patients at 50 clinical sites in 12 different countries in North America, Europe, and Asia Pacific. The China Food and Drug Administration approval will allow Celsion to enroll patients at up to 25 additional clinical sites in China, which will allow the firm to complete enrollment in the study by the end of 2017.
