Celsion has announced that the Data Safety Monitoring Board (DSMB) has reviewed the safety data from the first group of patients enrolled in its pivotal ThermoDox phase III clinical trial for primary liver cancer (HEAT study) and has recommended that Celsion continue to enroll patients in the trial.
The DSMB for the ThermoDox 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 DSMB reviews safety data at regular intervals and its charter is to ensure patient safety and monitor the quality and overall conduct of the study.
Michael Tardugno, president and CEO of Celsion, said: “We are pleased that the DSMB has recommended continuing the study based on its review of the safety data. We expect patient enrollment to continue to accelerate, as the trial was recently expanded to Japan in coordination with our exclusive Japanese license partner Yakult.
“We note that under our partnership, Yakult will bear all costs associated with the Japanese cohort. Additionally, Celsion anticipates that regulatory approval for new clinical sites in China is imminent. Together with the expected activation of sites in Malaysia, the Philippines, and Thailand, the Company projects 60 sites by year end. We expect to complete enrollment in the spring of 2010.”
The company said that 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 RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.