Celsion Reaches Major Milestone With Enrollment of 600th Patient in Its Pivotal Phase III HEAT Study of ThermoDox in Primary Liver Cancer

Celsion Corporation CLSN today announced that it has reached its pre-planned enrollment objective of 600 patients in the Company's pivotal, Phase III HEAT study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radio frequency ablation for the treatment of primary liver cancer. The enrollment objective was established to ensure that the study's primary end point, progression-free survival, can be achieved with adequate statistical power and is one of two triggers for an interim efficacy analysis by the study's independent Data Monitoring Committee. The second trigger is the confirmation of 190 PFS events in the study population. The HEAT study is being conducted under a U.S. Food and Drug Administration Special Protocol Assessment, has received FDA Fast Track Designation, and has been designated as a Priority Trial for primary liver cancer by the National Institutes of Health.