Enrollment starts in OPTIMA global study of ThermoDox as HCC therapy

The first patient enrolled in the OPTIMA study for primary liver cancer will be studied at the Kyungpook National University Hospital in South Korea, according to a news release.

The OPTIMA study is a double blind, placebo-controlled phase 3 clinical trial where liposomal encapsulated doxorubicin (ThermoDox, Celsion) and optimized radiofrequency ablation (RFA) will be used to treat patients with hepatocellular carcinoma (HCC) and be compared against controls treated with RFA alone.

“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,” Won-Young Tak, MD, PhD, of Kyungpook National University Hospital and Asia Pacific principal investigator for the OPTIMA study, said in the release. “The OPTIMA study builds on extensive clinical and preclinical data that point to the potential of ThermoDox, when combined with an optimized RFA regimen, to significantly improve patient outcomes.”

“Enrollment … marks a significant milestone in our effort to deliver ThermoDox as a novel, first-line treatment for patients with primary liver cancer,” Michael H. Tardugno, president and chief executive officer at Celsion, said in the release. “We are now focused on successfully executing the trial, which is designed to establish a clear path to approval in major liver cancer markets worldwide.”

Clinical results from the latest HEAT study showed ThermoDox improved overall survival by 57% in patients with HCC compared with RFA controls (HR=0.639; 95% CI, 0.419-0.974).