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Celsion Receives COMP Recommendation for Orphan Drug Designation in Europe for ThermoDox® to Treat Primary Liver Cancer
Date:11/11/2010

ctive 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® and the Phase III HEAT StudyThermoDox® 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.  In the HEAT study, ThermoDox® is administered intravenously in combination with RFA.  Localized mild hyperthermia (39.5-42 degrees Celsius) created by the RFA 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® is being evaluated in a 600 patient global Phase III study at 76 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival.  A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the trial is complete and 190 PFS events are realized in the study population.  Additional information on the Company's ThermoDox® clinical studies may be found at http://www.clinicaltrials.gov

About CelsionCelsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination wit
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1. Celsion Announces ThermoDoxs Prominence in Abstracts Presented at the 2nd International MR-Guided Ultrasound Symposium
2. Data Monitoring Committee Unanimously Recommends Continuation of Celsions Phase III ThermoDox® HEAT Study to Treat Primary Liver Cancer
3. Celsion Receives SBIR Grant To Expand Its Technology Platform
4. Celsion Receives Fast Track Designation for ThermoDox® Development Program to Treat Primary Liver Cancer
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