DMC Unanimously Recommends Continuation of Celsion's Phase III ThermoDox® HEAT Study to Treat Primary Liver Cancer
Product News Feb 14, 2011
Celsion Corporation has announced that after reviewing data from 482 randomized patients in its multinational, randomized, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radio frequency ablation for primary liver cancer (the HEAT study), the study's Data Monitoring Committee (DMC) has unanimously recommended that the trial continue enrollment. The HEAT study has enrolled over 86% of the 600 patients necessary to ensure that its primary end point, progression free survival, can be achieved with statistical significance.
"The DMC's recommendation to continue enrollment in the HEAT study marks an important milestone for Celsion and ThermoDox®, as it is its final scheduled evaluation ahead of enrollment completion," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We remain optimistic and encouraged by this progress and by the potential for ThermoDox® to establish an effective standard of care for the enduring unmet need of patients with primary liver cancer."
The Company further announced that the DMC has maintained its recommendation to continue withholding enrollment of additional patients in Japan pending certain guidance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The recommendation follows a review of safety data from 18 Japanese patients enrolled in the study, when compared to patient data from the rest of the Phase III trial.
As a part of its commitment to Japan's PMDA, the DMC independently assesses patients randomized at Japanese sites. As previously noted, overall toxicities for patients in the HEAT study are consistent with doxorubicin's labeled safety profile. Doxorubicin, the active therapeutic in ThermoDox®, is a widely used chemotherapeutic with a well known safety profile and approved globally for use, including Japan, in many cancer indications.
Regarding enrollment in Japan, Mr. Tardugno added: "We will continue working with our Japanese development partner and the DMC toward a timely resolution and the resumption of patient enrollment in Japan. While this process is ongoing, current enrollment in the HEAT study is continuing at 66 sites in ten other countries. We intend to move forward toward enrollment and study completion."
The DMC for the HEAT study is comprised of an independent group of medical and scientific experts with the responsibility for reviewing and evaluating patient safety and efficacy data from the Company's Phase III HEAT study. The DMC reviews study data at regular intervals with their primary responsibilities to ensure the safety of all patients enrolled in the trial, the quality of the data collected, and the continued scientific validity of the trial design.
The trial design and statistical plan for the HEAT study also incorporates a pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete and 190 progression-free survival events are realized in the study population) with the intent of evaluating safety and efficacy results to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success (a futility analysis) to continue, modify or terminate the trial.