Updated results for study of ThermoDox in Liver Cancer-Celsion Corp

Celsion Corporation has announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox (heat-activated liposomal doxorubicin), in combination with radiofrequency ablation (RFA) in primary liver cancer. As of 15 January 2015, the latest quarterly overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox and optimized RFA provided a 59% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.628 with a p-value of 0.02. The data from the most recent quarterly HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox may significantly improve OS compared to a RFA control in patients whose lesions undergo optimized RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients.

The Phase III OPTIMA Study is expected to enrol up to 550 patients globally in up to 100 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The primary endpoint for the trial is overall survival, which is supported by post-hoc analysis of data from the Company's 701 patient HEAT Study.