Celsion Corporation has received official approval from China's State Food and Drug Administration (SFDA) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its phase-III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).
Celsion's global phase-III ThermoDox clinical trial is evaluating the efficacy and safety of ThermoDox in combination with radiofrequency ablation (RFA) when compared to RFA alone. The trial will enrol up to six hundred patients and is currently being conducted in Japan, Hong Kong, Korea, Taiwan, Italy, the United States and Canada. In addition to China, Celsion expects to receive CTA acceptance in Thailand, Malaysia, and the Philippines during the fourth quarter of 2009 and will have up to sixty sites activated by the end of the year. Completion of patient enrolment is expected to occur in the first half of 2010.
"Acceptance of our CTA in China is an important milestone for Celsion because China represents a significant market opportunity for ThermoDox", stated Michael H Tardugno, Celsion's president and chief executive officer. "The incidence of HCC in China is growing faster than any other country at over 350,000 patients per year (55 per cent of world's total incidence) and the use of RFA is becoming the standard of care for the treatment of early-stage HCC. Concurrent with sFDA's review of our application, we have identified and qualified rapid start-up sites in China which should enable patient enrolment to commence in the near-term. The expansion of the trial to China not only accelerates patient enrolment, but builds on our global strategy to conduct our phase-III trial in regions where the incidence of HCC is significant. Our goal is to enrol patients in key markets outside of the United States to facilitate regulatory approval in multiple countries, mainly East Asia, where the incidence is among the highest in the world."
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life.
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumour-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems.