Celsion completes patient enrollment in its global Phase III ThermoDox trial

Oct 21 2009

Celsion Corporation (NASDAQ: CLSN) announced today that it has completed a critical regulatory step in the countries of China and Japan to rapidly enroll patients in its global Phase III ThermoDox trial for the treatment of Hepatocellular Carcinoma (HCC), also known as primary liver cancer. The two instructional and educational meetings with principal investigators and institutional staffs were conducted in Tokyo and Beijing over the past ten days and were attended by over 60 physicians and surgeons who specialize in treating nonresectable liver cancer patients with radiofrequency ablation.

Celsion’s global Phase III HEAT trial is evaluating the efficacy and safety of ThermoDox in combination with RFA when compared to RFA alone. The trial will enroll up to six hundred patients and is currently being conducted in the United States, Canada, China, Japan, Hong Kong, Korea, Taiwan and Italy. Celsion has recently announced that its clinical trial applications (CTA) have been agreed to by regulatory authorities in the Philippines and Malaysia and will be initiating its trial in Southeast Asia shortly. Celsion expects to have more than sixty sites fully activated and enrolling patients by the end of the year. Completion of patient enrollment is expected to occur in the first half of 2010.

"Getting these new sites initiated, trained and ready to enroll patients in both Japan and China is representative of the importance of these two major markets and is consistent with Celsion’s objective to bringing the promise of ThermoDox to a needy global patient population as soon as possible,” stated Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “The incidence of HCC is growing at a reported 5% annually and is projected by the World Health Organization to be the world’s number one cancer by 2020. As RFA emerges globally as the first-line treatment for early stage HCC, ThermoDox is being evaluated for its potential to improve the efficacy of this cost effective procedure. The US FDA agreed to a Special Protocol Assessment (SPA) for this study with progression free survival as the primary and accelerated endpoint. Should the study hit the primary end point, Celsion is committed to filing for marketing approval in those countries where it is conducting the trial.”