OPTIMA study approved in Europe for potential liver cancer drug

Initiation of the phase 3 OPTIMA study has been approved in Europe via its centralized Voluntary Harmonization Procedure, or VHP, to test the safety and efficacy of a potential primary liver cancer drug, according to a press 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.

According to the VHP, Celsion Corporation will be able to conduct the OPTIMA study, its phase 3 clinical trial of ThermoDox for the treatment of HCC across Europe, including clinical sites in Italy, Spain and Germany.

“This approval allows us to expand our clinical program into key European countries, a critical element of our strategy to ensure study participation and thought leader support in major liver cancer markets worldwide,” Michael H. Tardugno, president and chief executive officer of Celsion, said in the release. “We are aggressively recruiting patients at sites in North America and the Asia Pacific region, and continue to pursue additional clinical trial application approvals in other key markets to further support this global trial.”

In September, the first patient was enrolled in the OPTIMA study and will be studied at the Kyungpook National University Hospital in South Korea. The study is still recruiting and enrolling patients at clinical sites across the United States, Hong Kong, South Korea, Malaysia and Thailand. Additional clinical sites in Canada, Taiwan, and the Philippines are expected to begin recruitment before the end of the year with China FDA regulatory approval to follow in early 2015, according to the release.

The Phase III OPTIMA Study is expected to enroll up to 550 patients globally, according to the release.

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).