DMC recommends Celsion to continue enrollment in ThermoDox clinical study for primary liver cancer

Celsion CorporationMay 14 2010

Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing data from 294 patients including data from 12 Japanese patients enrolled in the pivotal Phase III ThermoDox® clinical study (HEAT Study) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

The DMC for the HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DMC reviews study data at regular intervals with the charter to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DMC after patient enrollment is complete, with the intent to stop the study if there is overwhelming evidence of treatment benefit or a low probability of treatment success.

"We are pleased that the DMC has recommended continuation of the study based on its review of all of the available study data," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "The DMC's affirmative review of the 12 Japanese patients enrolled to date is a positive step forward, as it confirms Celsion and Yakult's decision to initiate Phase III trials in Japan.  The arrangement, to move directly into Phase III trials was based on previous evidence in primary liver cancer patients, may have shortened our timeline for approval in Japan by two years. With recent acceleration in patient recruitment, and the study now almost 60% enrolled, we are optimistic of a timely completion to enrollment."

Celsion's global Phase III ThermoDox study for primary liver cancer plans to enroll 600 patients and 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 for the study is progression-free survival.