Celsion, Yakult Honsha To Extend Phase III ThermoDox Trial To Japan

Celsion’s global phase III ThermoDox trial for the treatment of primary liver cancer will be extended to Japan by Yakult Honsha’s expertise. The latter is the exclusive licensor of Celsion’s ThermoDox in Japan.

Reportedly, under the license agreement between Celsion and Yakult, the latter is financially responsible for the patients enrolled in clinical trials in the Japanese sites. All the data generated in Japan will be jointly owned by both the companies and can be used by Celsion to support regulatory filings in territories outside of Japan.

Michael Tardugno, president and CEO, Celsion, said: “We are proud to announce that Yakult will initiate trial sites and begin patient enrollment in Japan for our Phase III liver cancer trial, and we look forward to working with Yakult. The extension of our PIII study to Japan will enable us to accelerate patient enrollment in the trial and has the potential to decrease the time to market in Japan.”

Dr. Kiyoshi Terada, head, Pharmaceutical Division/senior managing director, Yakult Honsha, said: “Japan has the highest rate of liver cancer in industrialized countries. Given there are limited effective treatment options for these patients, we are pleased to have the opportunity to provide ThermoDox to them in the clinical trial setting.”