The Data Monitoring Committee (DMC) has advised Celsion Corporation to continue enrolling patients for its liver cancer drug candidate, ThermoDox.
The recommendation follows the DMC's review of data from 294 patients in the pivotal Phase III study, including 12 Japanese patients.
Celsion's global Phase III study plans to enrol 600 patients and is being conducted under a US FDA Special Protocol Assessment (SPA).
The Phase III study is designed to evaluate the efficacy of the drug in combination with radiofrequency ablation (RFA) compared with patients receiving RFA alone as the control. The endpoint of the study is progression-free survival.
Celsion expects to complete the study by mid-2011, while a new drug application should be submitted before the end of 2011.
There are an estimated 20,000 primary liver cancer cases every year in the US and one million cases annually worldwide, due to the high prevalence of Hepatitis B and C in developing countries.