Celsion Reports that Sufficient Events Have Been Reached for the Second Interim Analysis of the Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer
Celsion Corporation (CLSN)
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Source: GlobeNewswire
Independent Data Monitoring Committee is Expected to Meet in July 2020 to Evaluate Overall Survival Data LAWRENCEVILLE, N.J., April 15, 2020 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), an oncology drug-development company, announces that the prescribed minimum number of events of 158 patient deaths has been reached for the second pre-specified interim analysis of the OPTIMA Phase III Study with ThermoDox® plus RFA (radiofrequency ablation) in patients with hepatocellular carcinoma (HCC), or primary liver cancer. Following preparation of the data, the Independent Data Monitoring Committee (iDMC) is expected to meet in July to conduct the second interim analysis. Celsion expects to announce iDMC recommendations as soon as possible after the meeting. The hazard ratio for success at 158 deaths is 0.70, which represents a 30% reduction in the risk of death compared with RFA alone. This compares favorably with the hazard ratio of 0.65 observed in the prospective HEAT
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