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news.Celsion has secured approval via Europe's centralized Voluntary Harmonization Procedure (VHP) to conduct the Phase III OPTIMA trial of ThermoDox in primary liver cancer, also known as hepatocellular carcinoma (HCC), in Europe.
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The trial is designed to assess ThermoDox in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat patients with non-resectable HCC lesions.
ThermoDox is the company’s proprietary heat-activated liposomal encapsulation of doxorubicin.
Around 550 patients globally are expected to be enrolled in the Phase III trial, in about 100 clinical sites in the US, Europe, China and Asia Pacific.
Apart from Italy, the global pivotal, double-blind, placebo-controlled Phase III OPTIMA trial will now include sites in Spain and Germany.
The OPTIMA trial is recruiting and enrolling patients at sites in the US, Hong Kong, South Korea, Malaysia and Thailand.
The company intends to start patient enrollment at additional clinical sites in Canada, Taiwan and the Philippines before the end of this year, while the regulatory approval from the China FDA (CFDA) is expected to follow in early 2015.
Celsion chairman, president and chief executive officer Michael Tardugno said: "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.
"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."
The primary endpoint is overall survival (OS), which is supported by post-hoc analysis of data from the company’s 701 patient HEAT Study, where optimized RFA has showed potential to significantly improve survival when combined with ThermoDox.