Celsion Corp. (CLSN) announced Thursday that ThermoDox in combination with radiofrequency ablation or RFA did not meet the primary endpoint of the Phase III HEAT Study in patients with hepatocellular carcinoma or HCC, also known as primary liver cancer.
The company said it 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 or FDA.
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.
HEAT or Hepatocellular Carcinoma Study of RFA and ThermoDox was an international, multi-center, randomized, placebo-controlled study that randomized 701 patients with intermediate (tumor size 3 cm to 7 cm), unresectable HCC to 50mg/m2 ThermoDox plus RFA or RFA alone. The primary endpoint of the study was progression-free survival, as defined by the Special Protocol Assessment agreed to with the U.S. FDA. Safety and tolerability were also evaluated.
The HEAT Study was conducted at 79 clinical sites around the world, including the United States, Canada, Italy, China, Taiwan, Hong Kong, Korea, Thailand, Malaysia and the Philippines.
Hepatocellular carcinoma, also known as primary liver cancer, is currently one of the most common and deadly forms of cancer worldwide. HCC is the fourth leading cause of death from cancer and the third most common in males. HCC currently is the world's fifth largest cancer and the World Health Organization estimates that HCC may become the number one cancer worldwide by 2020, surpassing lung cancer.
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