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Celsion (CLSN) Says ThermoDox Missed Primary Endpoint in Phase III HEAT

January 31, 2013 7:03 AM EST Send to a Friend
Celsion Corporation (NASDAQ: CLSN) announced that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.

Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study. The HEAT Study was designed to show a 33% improvement in PFS with 80% power and a p-value = 0.05. In the trial, ThermoDox® was well-tolerated with no unexpected serious adverse events. The HEAT Study was conducted under a Special Protocol Assessment agreed to with the U.S. Food and Drug Administration (FDA).

Celsion ended 2012 with a strong balance sheet that provides the Company the opportunity to evaluate its future development plans. The Company projects its unaudited cash and investment balance to be approximately $23 million as of December 31, 2012 and approximately $27 million as of January 31, 2013.




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