Celsion announced updated results from its HEAT Study post-hoc analysis which examined the use of ThermoDox, a heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer. Celsion also released a review of the final study design of the Phase 3 OPTIMA study which will investigate the use of ThermoDox for the same indication.
As of March 31, 2014, data from the HEAT Study post-hoc analysis demonstrated that ThermoDox may 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 the 3–5cm and 5–7cm cohorts of the HEAT study and represent a subgroup of 285 patients (41%). For this subgroup, clinical results indicate a 50% improvement in overall survival (HR: 0.666; 95% CI 0.434–1.022; p-Value=0.06). The median overall survival for this subgroup has not been met yet.
Celsion anticipates patient enrollment in the OPTIMA Study to begin in mid-2014.
For more information call (609) 896-9100 or visit Celsion.com.