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Celsion Corporation Reports Second Quarter 2013 Financial Results and Provides HEAT Study Update
Date:8/8/2013

LAWRENCEVILLE, N.J., Aug. 8, 2013 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced financial results for the second quarter ended June 30, 2013 and an update from its retrospective analysis of the clinical trial results for ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin.  ThermoDox® is being evaluated in a global, multi-center Phase III clinical trial (the HEAT Study) in patients with non-resectable hepatocellular carcinoma (HCC), also known as primary liver cancer.  ThermoDox® is also being evaluated in a Phase II trial for patients with recurrent chest wall breast cancer (the DIGNITY Study).

Following the announcement on January 31, 2013, that ThermoDox® in combination with radiofrequency ablation (RFA) did not meet the HEAT Study's primary endpoint, the Company has conducted a comprehensive analysis of the data from the Study supported by its key principal investigators as well as liver cancer and clinical data experts. The Company continues to follow patients enrolled in the HEAT Study to the secondary endpoint, Overall Survival (OS). 

As of the June 30, 2013 cut off, the date of the latest OS patient follow-up,  Celsion reports the following:

  • Overall Survival has not yet reached the median for the full HEAT Study population.  A total of 226 deaths have been recorded through June 30, 2013.
  • Subgroup analysis based on RFA heating duration continues to suggest that ThermoDox® markedly improves Overall Survival, when compared to the control group, in patients if their lesions undergo RFA for 45 minutes or more.  These findings apply to single HCC lesions (63% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent approximately 300 patients. '/>"/>

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