Celsion Corporation (NASDAQ: CLSN) and Yakult Honsha Co., Ltd. (Tokyo: 2267) announced today that the first patient has been enrolled and treated in Japan as part of Celsion’s global Phase III ThermoDox HEAT trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.
Yakult is the exclusive licensee of Celsion’s ThermoDox for the Japanese territory and is responsible for funding clinical trials in Japan and obtaining regulatory and marketing approval. The clinical data from the Japanese cohort will be incorporated into Celsion’s overall ThermoDox Phase III study results and is also intended to support a potential marketing approval submission by Yakult in Japan.
“Yakult’s rapid start up of clinical sites and the enrollment of the first Japanese patient is a testament to their oncology expertise and strong commitment to commercialize ThermoDox in Japan,” stated Michael H. Tardugno, Celsion’s Chief Executive Officer. “With Yakult’s recent decision for participation to the study to include Japanese sites we expect to see an acceleration of patient enrollment and the potential to significantly decrease ThermoDox’s time to market in Japan should the data support registration.”
“ThermoDox holds the potential to become a significant drug in our pharmaceutical portfolio and an important addition to our oncology franchise,” stated Dr. Kiyoshi Terada, Head, Pharmaceutical Division/Senior Managing Director, and Member of the Board of Yakult. “Yakult’s decision to invest in ThermoDox was based on the remarkable evidence of clinical activity demonstrated in early stage clinical trials. ThermoDox holds great promise for those afflicted with HCC, as currently there is no chemotherapeutic standard of care.”