Celsion says DMC recommends continuation of OPTIMA study of ThermoDox
Celsion Corporation announced that the independent Data Monitoring Committee for the company's 550-patient, multinational, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox in combination with radiofrequency ablation for primary liver cancer, has unanimously recommended that the study continue according to protocol to its data readout. The DMC's recommendation was based on the committee's assessment of safety and data integrity of the first 75% of patients randomized in the trial as of February 5, 2018. The DMC consists of an independent group of medical and scientific experts responsible for reviewing and evaluating patient safety and efficacy data for the company's Phase III OPTIMA Study. The DMC reviews study data at regular intervals in order to ensure the safety of all patients enrolled in the trial and to monitor the quality and overall conduct of the trial, including each site's compliance with the minimum RFA heating time of 45 minutes, which is specified in the study protocol. The OPTIMA Study's design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC 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.