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Data Monitoring Committee Unanimously Recommends Continuation of Celsion's Phase III ThermoDox® HEAT Study to Treat Primary Liver Cancer
Date:9/30/2010

COLUMBIA, Md., Sept. 30 /PRNewswire-FirstCall/ -- Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study (the HEAT study) for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study.  The Company previously announced that the U.S. Food and Drug Administration (FDA) designated the HEAT study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program.  ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in this global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer.  With nearly 75% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment over the next 4 months.  As a part of its commitment to Japan's PMDA, the DMC will continue to independently assess safety in patients randomized at Japanese sites.  The goal is to provide data from this cohort sufficient to support immediate registration in Japan following a successful study.

The DMC for the HEAT study is comprised of an independent group of medical and scientific experts with the responsibility for reviewing and evaluating patient safety and efficacy data from the Company's Phase III ThermoDox HEAT study.  The DMC reviews study data at regular intervals with their primary responsibilities to ensure the safety of all patients enrolled in the trial, the quality of the data collected, and the continued scientific
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