LAWRENCEVILLE, N.J., Nov. 29, 2016 -- Celsion Corporation (NASDAQ:CLSN) today announced the presentation of results from an independent retrospective analysis conducted by the National Institutes of Health (NIH) on the intent-to-treat population of the Company’s HEAT Study, a 701-patient study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). The findings of the NIH study were presented during The Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma at the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) on Monday, November 28, 2016 from 1:00 pm to 6:00 pm CT and was moderated by Professor Riccardo Lencioni, lead European Investigator on Celsion’s HEAT Study. Celsion is currently studying the use of RFA as a heat source both for tumor ablation and to activate ThermoDox® as a means of affecting the area surrounding the tumor, where later recurrence most often takes place.

The NIH analysis was conducted under the direction of Dr. Bradford Wood, MD, Director, NIH Center for Interventional Oncology and Chief, NIH Clinical Center Interventional Radiology. The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome, concluded that increased burn time per tumor volume significantly improved overall survival (OS) in patients with solitary lesions treated with RFA + ThermoDox® compared to patients treated with RFA alone. More specifically, the analysis showed that a one unit increase in RFA duration per tumor volume improved OS by 20% in patients treated with optimized RFA + ThermoDox® compared to RFA alone.

This novel way of assessing the impact of the drug takes into account both the size of the tumor and the time of ablation, both of which appear to be important factors. The NIH analysis included 437 patients with a single lesion from the Company’s HEAT Study, the same patient population being treated in the Company’s ongoing Phase III OPTIMA Study. These findings are consistent with Celsion’s own analysis of the HEAT Study data, which demonstrated that over a 3.5 year period, there was a statistically significant two (2) year survival benefit for patients treated with ThermoDox® plus optimized RFA over the optimized RFA only group.

"There is clear evidence that the duration of the RFA regimen used in combination with ThermoDox® is critical, as was demonstrated in the NIH’s independent analysis," said Riccardo Lencioni, MD, FSIR, EBIR, Professor of Interventional Radiology, Vice Chair, Clinical and Translational Research, Department of Interventional Radiology, University of Miami School of Medicine. "Findings from this analysis provide additional confirmation that increased RFA burn time improves OS in patients administered ThermoDox®. For patients with intermediate HCC who are not optimal candidates for surgery, there exists a dire unmet need, and being able to offer these patients optimized RFA + ThermoDox® has the potential to be a meaningful paradigm shift in the current management of this deadly disease.”

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