Celsion Corporation has announced that the first patient has been enrolled in its pivotal phase III OPTIMA study of ThermoDox in combination with optimised radiofrequency ablation in patients with hepatocellular carcinoma. The first patient was treated at Kyungpook National University Hospital in South Korea.
ThermoDox is the company’s proprietary, heat-activated, liposomal encapsulation of doxorubicin.
The phase III OPTIMA study is a global, pivotal, double-blind, placebo-controlled clinical trial that is expected to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific. The study is evaluating ThermoDox in combination with optimised radiofrequency ablation, which will be standardised to a minimum of 45 minutes across all investigators and sites for treating lesions 3–7cm vs. standardised radiofrequency ablation alone. The primary endpoint for the trial is overall survival. The statistical plan calls for two interim efficacy analyses by an independent data monitoring committee.
“There is an urgent need for new treatment options that address primary liver cancer, a rapidly progressing disease with a poor prognosis whose worldwide incidence is growing at an alarming rate,” stated Won-Young Tak, Kyungpook National University Hospital, South Korea, and Asia Pacific principal investigator for the OPTIMA Study. “The OPTIMA Study builds on extensive clinical and preclinical data that point to the potential of ThermoDox, when combined with an optimised radiofrequency ablation regimen, to significantly improve patient outcomes. I look forward to working with my colleagues to further explore the clinical utility of ThermoDox in this setting.”
As of June 30, 2014, data from the latest HEAT study post-hoc analysis continued to strongly suggest that ThermoDox may significantly improve overall survival compared to a radiofrequency ablation control in patients whose lesions undergo ablation treatment for 45 minutes or more. These findings apply to patients with single hepatocellular carcinoma lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3–5 cm and 5–7cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in overall survival, a hazard ratio of 0.639 (95% CI 0.419–0.974), and a p-value of 0.037.