Study shows ThermoDox improves OS in Liver Cancer patients - Celsion

Celsion has announced that updated results from the 701 patient HEAT Study post-hoc analysis, as well as a review of the final study design of the Phase III OPTIMA Study, which both explore ThermoDox (heat activated liposomal encapsulation of doxorubicin) in combination with radiofrequency ablation (RFA) for the treatment of primary Liver Cancer. Data from the latest HEAT Study post-hoc analysis as of March 31, 2014 suggest that ThermoDox may markedly improve overall survival, compared to RFA control, in patients whose lesions undergo 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 (41% of the patients in the HEAT Study).

For this subgroup, clinical results indicate a 50% improvement in overall survival. The median overall survival for this subgroup has not yet been reached. In addition to the US, Celsion is planning to conduct the OPTIMA Study in up to 100 centers in 14 countries in Asia, Europe and North America, and anticipates patient enrollment in this multicenter global trial to begin in mid-2014.