ThermoDox heat-activated liposome: Additional Phase III data

A post hoc analysis of patients whose radiofrequency ablation procedure lasted >=45 minutes in the double-blind, sham-controlled, international Phase III HEAT trial in 701 patients with intermediate, unresectable HCC showed that IV ThermoDox plus radiofrequency ablation improved OS by 53% vs. radiofrequency ablation alone (p=0.105). Median OS has not yet been reached. Celsion said that assuming its hypothesis is supported by non-clinical studies, as well as continued follow-up of patients in the HEAT trial to the OS endpoint, the company will meet with FDA to discuss the findings. ...