An independent data monitoring committee (DMC) for Celsion’s multinational, double-blind, placebo-controlled Phase III clinical study of ThermoDox in combination with radiofrequency ablation (RFA) for primary liver cancer has completed a review of 535 randomized patients and unanimously recommended that the study continue according to protocol.
Celsion also announced that enrollment in the Heat study has reached 98% of the 600 patients necessary to ensure that its primary end point, progression free survival, can be achieved with statistical significance.
The study’s design and statistical plan incorporate a pre-planned interim efficacy analysis by the DMC—after patient enrollment is complete and 190 progression-free survival (PFS) events are realized in the study population—with the intent of evaluating safety, efficacy, and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study. Completion of the interim analysis is expected by the end of the third quarter of 2011.
“For the vast majority of patients, progression in unresectable primary liver cancer treated using conventional radiofrequency ablation therapy occurs within one year, underscoring the urgent need for more effective treatment in first-line care,” says Michael H. Tardugno, president and chief executive officer of Celsion.
“ThermoDox is designed to concentrate doxorubicin in the margins surrounding the tumor, activating only in the presence of heat. Our data strongly indicate that the result is an increase treatment area which may extend the cure rate of RFA to larger, more locally advanced tumors. The Heat study is poised to confirm this potential, with final data read out for the primary outcome measure expected in mid-2012.”
Release Date: July 11, 2011
Filed Under: Drug Discovery