Celsion Corporation announced that after reviewing safety data from 120 patients enrolled in the pivotal phase-III ThermoDox clinical trial (HEAT trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enrol 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 safety data at regular intervals with the mandate 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 enrolment is complete, with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.
"We are pleased that the DMC has recommended continuation of the study based on its review of the safety data," stated Michael H Tardugno, president and chief executive officer of Celsion. "We currently have 60 sites enrolling patients in 11 countries and plan to have 70 sites with patients by the end of February. With recent acceleration in patient recruitment, and the study now nearly 50% enrolled, we project that the trial will be fully enrolled within the next two quarters."
Celsion's global phase-III ThermoDox study for primary liver cancer is enrolling 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.
ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumour-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems.