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Celsion Announces Results Of Phase III HEAT Study Of ThermoDox® In Primary Liver Cancer

About the HEAT Study

HEAT ( He patocellular Carcinoma Study of RF A and T hermoDox®) 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/m 2 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, the largest clinical trial to date in patients with intermediate HCC, 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.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC), also known as primary liver cancer, is currently one of the most common and deadly forms of cancer worldwide. With few approved treatment options, it is estimated that up to 90 percent of unresectable (inoperable) liver cancer patients will die within five years of diagnosis. HCC is the fourth leading cause of death from cancer and the third most common in males. There are approximately 26,000 new cases per year in the US and approximately 40,000 cases per year in Europe. However, HCC is rapidly growing worldwide at approximately 750,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries - more than 50 percent of these new cases will be in China. 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.

About ThermoDox®

ThermoDox® is an investigational, proprietary heat-activated formulation of liposomal doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers, and is currently being investigated in clinical trials for its potential to treat patients with intermediate (tumor size 3 to 7 cm), unresectable (inoperable) HCC.  ThermoDox® is an investigational treatment and is not approved by the FDA, EMA or other health authorities.  

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