Celsion Provides Update on Progress of ThermoDox® Phase III Study for Primary Liver Cancer
News Dec 04, 2009
Celsion Corporation has provided an update on the progress of its pivotal ThermoDox® Phase III “HEAT” trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
Following recent regulatory approvals in China, Malaysia, Thailand and the Philippines, the study is now enrolling patients in eleven countries, with the majority of clinical sites located in the Asia Pacific region where HCC is most prevalent.
Enrollment in this 600 patient study continues to accelerate and Celsion expects to meet its objective of completing enrollment by the middle of 2010. A pre-planned, un-blinded interim efficacy analysis will be performed by an independent Data Management Committee when 50% of the endpoint events, tumor recurrence, are realized in the study population. Based on an historical review of RFA cases, Celsion expects the study could be completed by the middle of 2011, and pending positive data, a NDA would be submitted to the FDA before the end of 2011.
Michael H. Tardugno, President and Chief Executive Officer of Celsion stated, “We are pleased with the progress of patient enrollment and expect this trend to continue, based on the rapid start-up of additional clinical sites in China and other Asia Pacific countries.
By year end, we expect to have sixty sites enrolling patients, with the majority of patients in countries such as China, Korea, Taiwan and Japan, where HCC is endemic. We have capital sufficient to complete enrollment and should the study show a benefit consistent with its primary endpoint, we would expedite filing for regulatory approvals in the U.S. and other countries where the trial is being conducted.”
Celsion’s global ThermoDox Phase III study for primary liver cancer is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint is progression free survival with a secondary confirmatory endpoint of overall survival.