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Celsion Receives Fast Track Designation for ThermoDox® Development Program to Treat Primary Liver Cancer
Date:8/24/2010

ry review for new drugs that treat serious or life threatening diseases which are not satisfactorily treated by existing therapies, or for drugs that provide a significant advantage over existing therapies for serious diseases.  Under the Fast Track Designation, Celsion is now eligible to submit a U.S. New Drug Application (NDA) on a rolling basis.  This permits the FDA to review sections of the NDA in advance of receiving the complete submission.

About Primary Liver CancerPrimary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer.   The incidence of primary liver cancer is approximately 20,000 cases per year in the United States and is rapidly growing worldwide at approximately 1,000,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries.  The standard first line treatment for liver cancer is surgical resection of the tumor; however 80% to 90% of patients are ineligible for surgery.  Radio frequency ablation (RFA) has increasing become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.

About ThermoDox®ThermoDox® in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

For primary liver cancer, ThermoDox
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SOURCE Celsion Corporation
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