FDA approves new Phase III trial for Celesion's ThermoDox

The FDA has cleared Celesion's (CLSN +6.35%) Optima Phase III trial of its ThermoDox therapy for treating hepatocellular carcinoma (HCC), the most common type of liver cancer.

In a previous late-stage study, called Heat, ThermoDox failed in its primary goal of progression-free survival. However, ThermoDox did improve overall survival rates by 55% in a substantial number of HCC patients.

Celsion expects to launch the new study in the first half of 2014; the primary endpoint is overall survival. (PR)

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