Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Celsion CorporationOct 19 2009

Celsion Corporation (NASDAQ: CLSN) announced today that it has received approval from the regulatory agencis in the Philippines and Malaysia for its Pivotal Phase III primary liver cancer Clinical Trial Application.

Celsion’s global Phase III trial is evaluating the efficacy and safety of ThermoDox in combination with radiofrequency ablation (RFA) when compared to RFA alone. The trial will enroll up to six hundred patients and is currently being conducted in China, Japan, Hong Kong, Korea, Taiwan, Italy, the United States and Canada. Expansion of the trial to the Philippines and Malaysia provides assurance that the trial will be enrolled in an efficient and timely manner. With recently announced CTA approval by the Chinese sFDA and imminent agreement by the Thai FDA, Celsion expects to have sixty sites activated by the end of the year. Completion of patient enrollment is expected to occur in the first half of 2010.

"Acceptance of our CTA by the Philippine and Malaysian regulatory authorities provides Celsion with trial agreements in key countries where primary liver cancer is most prevalent. We have again posted a significant milestone and are executing against our strategy to conduct our Phase III HCC study in a manner that will provide basis for NDA submissions in regions where liver cancer is endemic,” stated Michael H. Tardugno, Celsion’s President and Chief Executive Officer. “We now successfully secured regulatory authorization in 10 of 11 targeted countries covering approximately 80% of the world’s HCC population. With the incidence of HCC growing at a reported 5% annually, the World Health Organization projects it to be the world’s #1 cancer by 2020.”

Mr. Tardugno concluded, “With RFA emerging as the global first line treatment for early stage HCC; ThermoDox’s potential to improve the efficacy of this cost effective procedure provides Celsion with a significant ready made market. Our goal is to provide the promise of our tumor targeting anti-cancer technology to HCC patients with few options as rapidly as possible.”