Celsion Completes Consultative Review Process With EMA for Phase III HEAT Study of ThermoDox in Primary Liver Cancer
Celsion Corporation (NASDAQ: CLSN) 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.
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