Celsion has completed the enrollment and treatment of the first patient in China, as part of Phase III ThermoDox Heat trial for the treatment of hepatocellular carcinoma (HCC).
Following recent regulatory approvals in China, Malaysia and the Philippines, the study is now recruiting patients in ten of eleven planned countries, with the majority of clinical sites located in the Asia Pacific region where HCC is most prevalent.
Celsion’s clinical strategy is designed to enroll a sufficient number of patients to support regulatory filing in China, and in key Asian markets including, Japan, Taiwan, and Korea. This approach is intended to reduce the time to approval and support licensing negotiations in countries.
Celsion’s ThermoDox Phase III study for primary liver cancer is being conducted under a special protocol assessment with the FDA. The 600 patient study is designed to evaluate the efficacy of ThermoDox, in combination with RFA, when compared to patients who receive RFA alone as the control.
The primary endpoint is progression free survival (PFS) with a secondary confirmatory endpoint of overall survival. A preplanned, un-blinded interim efficacy analysis will be performed by an independent Data Management Committee when 50% of the PFS endpoint events are realised in the study population. Celsion expects the study to be completed by the middle of 2011, and pending positive data, a New Drug Application would be submitted to the FDA before the end of 2011.
Michael Tardugno, president and chief executive officer of Celsion, said: “Since regulatory approval, we have rapidly activated clinical sites and are pleased to have randomised the first patient in China with ThermoDox.
“We are on target to have over sixty clinical sites activated by the end of 2010, with 15 in China, and expect to complete enrollment in the study by the middle of 2010. With radio frequency ablation (RFA) emerging globally as a first-line treatment for early stage non-resectable HCC, ThermoDox has the potential to improve patient outcomes for this cost effective, minimally invasive procedure. Should the study achieve its primary objective, Celsion is committed to filing for marketing approval in all the countries where it is conducting the trial.”