Celsion (CLSN) Announces Substantial Data from Independent NIH Analysis of HEAT Study

September 12, 2016 8:07 AM EDT

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Celsion Corporation (Nasdaq: CLSN) announced that the National Institutes of Health (NIH) has conducted an independent retrospective analysis of data from the intent-to-treat population of the Company’s HEAT Study, a 701-patient study investigating 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 will be presented during an oral session on Monday, November 28, 2016 at 1:50 pm CT during the 102nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) to be held on November 26 – December 2, 2016 in Chicago, IL. Celsion is currently studying the use of RFA as a heat source both for tumor ablation and to activate ThermoDox® as a means of treating the area surrounding the tumor, where untreated tumor may be present.

The NIH analysis, which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome in patients treated with ThermoDox, concluded that increased burn time per tumor volume substantially improved survival in patients with solitary lesions treated with RFA + ThermoDox® compared to patients treated with RFA alone. These findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox resulted in a statistically significant improvement in overall survival (OS) compared to standardized RFA alone.

“The NIH’s independent analysis provides new confirmatory support indicating that the use of RFA for more than 45 minutes in patients treated with ThermoDox can have a correlative impact on reductions in tumor size and overall survival in patients with primary liver cancer,” said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. “We are encouraged that the NIH findings are consistent with Celsion’s analysis of the HEAT Study data showing that in patients treated with RFA for more than 45 minutes, standardized RFA plus ThermoDox demonstrated a statistically significant improvement in overall survival compared to standardized RFA alone.”

Mr. Tardugno added, “We also think it is noteworthy that Celsion’s latest 285 patient subgroup OS readout from the HEAT Study reported that over a 3.5 year period, there was a consistent two-year survival benefit for patients with primary liver cancer – one of the most prevalent and most deadly types of cancer in the world – who were treated with ThermoDox plus optimized RFA over the optimized RFA-only group.”

“We are pleased that the NIH findings will be presented to the scientific community at the 2016 RSNA Annual Meeting. We firmly believe that this event will advance the understanding of new and potentially curative approaches to the treatment of primary liver cancer, and that it will also provide strengthened validation for our ongoing global Phase III OPTIMA study, which is evaluating ThermoDox in combination with optimized RFA standardized to a minimum of 45 minutes versus standardized RFA alone in the treatment of primary liver cancer,” Mr. Tardugno said.

Presentation Details

Abstract Number: 16013790

Title: RFA Plus Lyso Thermosensitive Liposomal Doxorubicin Improves Survival Using Metric of RFA Duration per Tumor Volume: Retrospective Analysis of Prospective Randomized Controlled Trial

Session: Interventional Oncology Series: Hepatocellular Carcinoma and Cholangiocarcinoma (VSI021)

Date and Time: Monday, November 28, 2016, 1:00 pm to 6:00 pm



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