ThermoDox heat-activated liposome: Phase III started

Celsion began the double-blind, placebo-controlled, international Phase III OPTIMA trial to compare ThermoDox in combination with optimized radiofrequency ablation (RFA) vs. RFA alone in about 550 HCC patients. In January 2013, Celsion reported that ThermoDox plus RFA missed the primary endpoint of improving PFS vs. RFA alone in the Phase III HEAT trial to treat non-resectable HCC (see BioCentury, Feb. 4, 2013). ThermoDox is also in the Phase I/II DIGNITY trial to treat recurrent chest wall breast cancer. The product has Orphan Drug designation for HCC in the EU and U.S., where it also has Fast Track designation. ...