US-based Pharmaceutical firm Celsion has received regulatory clearance to start its global pivotal, double-blind, placebo-controlled Phase III OPTIMA Study at clinical trial sites in Taiwan, Hong Kong, South Korea and Canada.
The trial is designed to evaluate ThermoDox, the company’s proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA), in patients with primary liver cancer, also known as hepatocellular carcinoma (HCC).
In addition, the company continues to advance its global regulatory strategy and has filed clinical trial applications in the Philippines and Thailand, as well as a request for a voluntary harmonisation procedure (VHP) in Europe.
VHP facilitates the assessment of multinational clinical trial applications across several European countries including Germany, France and Spain.
Celsion has already submitted an application for accelerated trial approval to the China Food and Drug Administration (CFDA).
The company also intends to expand its clinical site footprint in Europe and will meet with the European Medicines Agency (EMA) this year to discuss ThermoDox trial design and registrational strategy.
Celsion president and chief executive officer Michael Tardugno said the company is building momentum with its global regulatory efforts and establishing paths to approval in critical liver cancer markets worldwide.
"Following US FDA-clearance for the OPTIMA Study earlier this year and with the strong support of the HCC research community, we have been accelerating our efforts in support of clinical trial sites in the other major markets, including China, Asia Pacific and the European Union, and are well-positioned to enroll our first patient mid-year 2014," Tardugno said.
Around 550 patients are expected to be enrolled in the trial, with up to 100 sites in the US, Europe, China and Asia Pacific.
The Phase III trial is designed to evaluate ThermoDox in combination with optimised RFA, which will be standardised to a minimum of 45 minutes across all investigators and sites for treating lesions 3cm to 7cm, versus standardised RFA alone.
Primary endpoint for the trial is overall survival (OS), which is supported by post-hoc analysis of data from Celsion’s 701 patient HEAT Study, where optimised RFA has showed potential to significantly improve survival combined with ThermoDox.