ThermoDox (Celsion) shows OS benefits in Liver Cancer trial

New overall survival (OS) data from a post-hoc analysis of results from the Phase III HEAT Study of ThermoDox (heat activated liposomal doxorubicin), from Celsion, supports continued clinical development through a prospective pivotal Phase III Study. This followed the announcement on January 31, 2013, that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the Study's primary endpoint, progression-free survival. However the data from the post-hoc analysis suggests that ThermoDox may markedly improve overall survival, when compared to the control group, in patients if their tumors undergo optimal RFA treatment.

In the patient subgroup treated in the ThermoDox arm whose RFA procedure lasted longer than 45 minutes (285 patients or 63% of single lesion patients) clinical results indicate an improvement in overall survival with a Hazard Ratio of 0.63. In contrast, the patients group whose RFA procedure lasted less than 45 minutes in duration demonstrated a Hazard Ratio of 1.14. The HEAT Study has not reached its median for overall survival analysis and Celsion continues to follow all patients to the secondary endpoint. Celsion expects to submit its proposed pivotal Phase III clinical protocol for FDA review in the fourth quarter of 2013 and anticipates initiating a multicenter global trial in the first half of 2014.