Celsion plummets on Phase III miss
Celsion Corp. (NASDAQ:CLSN) fell $6.51 (81%) to $1.51 on Thursday after reporting that IV ThermoDox plus radiofrequency ablation missed the primary endpoint of improving progression-free survival (PFS) vs. radiofrequency ablation alone in the Phase III HEAT trial to treat non-resectable hepatocellular carcinoma (HCC). The double-blind, sham-controlled trial was designed to show a 33% improvement in PFS with 80% power and a p-value of 0.05. Celsion, which has an SPA from FDA for the trial, said it will consider following the 701 patients enrolled in the trial to evaluate the secondary endpoint of overall survival (OS). The company declined to provide details, but said it is also conducting additional analysis of the data to assess the "future strategic value" of ThermoDox. ...