Celsion Completes Consultative Review Process With EMA for Phase III HEAT Study of ThermoDox in Primary Liver Cancer

Celsion Corporation

announced today that it has received written, scientific advice from the European Medicines Agency confirming that the Company's Phase III HEAT Study, a multinational, double-blind, placebo controlled pivotal study of ThermoDox® in combination with radio frequency ablation for the treatment of hepatocellular carcinoma, or primary liver cancer, is acceptable as a basis for submission of a marketing authorization application. Based on feedback and guidance received from the EMA, the Company expects that future results demonstrating a convincing magnitude of improvement in progression-free survival, the study's primary endpoint, along with a favorable benefit-risk ratio in the HEAT Study, would be sufficient as the primary basis for registration of ThermoDox® in Europe. The EMA also supported the Company's manufacturing strategy and technology transfer protocols, which will allow the Company to establish multiple manufacturing sites to support commercialization of ThermoDox® outside the United States.