Data Monitoring Committee Completes Planned Safety and Data Review of Celsion’s Phase III OPTIMA Study

Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that the independent Data Monitoring Committee (DMC) for the Company’s 550-patient, multinational, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radiofrequency ablation (RFA) for primary liver cancer (the OPTIMA Study), 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.

As quoted in the press release:

“The DMC’s latest recommendation to continue the ongoing OPTIMA Study further supports our confidence in ThermoDox® and the OPTIMA Study’s design to demonstrate the safety and effectiveness of ThermoDox® plus standardized RFA therapy in the treatment of patients with primary liver cancer,” said Nicholas Borys, M.D., Celsion’s senior vice president and chief medical officer. “An important feature of the OPTIMA Study protocol is investigators’ adherence to RFA heating time of greater than 45 minutes for tumors greater than three centimeters – a key determination from the in-depth analyses of our previously completed HEAT Study. Based on the DMC’s review of the 411 patients enrolled in the OPTIMA Study as of February 5, 2018, it concluded that the integrity of the study is intact and that ThermoDox® is safe for continued enrollment of newly diagnosed, intermediate-stage patients. We note also that in the analysis of blinded data from the intent-to-treat population, consolidated for both arms, median progression free survival (PFS) was 20.8 months. This compares favorably to the HEAT Study median PFS of 13.8 months and is consistent with the hypothesis-generating estimates from the HEAT Study manuscript published in the October 2017 issue of the peer-reviewed medical journal, ‘Clinical Cancer Research.’”

Click here to read the full press release.