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Liver Cancer | Celsion Announces Updated Overall Survival Data From HEAT Study Of ThermoDox In Primary Liver Cancer

LAWRENCEVILLE, N.J., July 28, 2014 /PRNewswire/ –Celsion Corporation ( CLSN ) today announced

“As the data from the HEAT Study matures, it increasingly underscores the significant potential of ThermoDox plus optimized RFA to markedly improve Overall Survival in primary liver cancer patients,” stated Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy. “There is a pressing need for new treatment options to address HCC, which is a highly prevalent and deadly cancer. The consistency and strength of the HEAT Study data over each of the last five quarterly data analyses provide a strong rationale and clear roadmap for further development of ThermoDox in this indication.”

As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox may significantly improve OS compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI 0.419 ” 0.974), and a p-value of 0.037.



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“The post-hoc HEAT Study data is striking in that it has consistently shown a marked OS benefit for ThermoDox plus optimized RFA versus RFA alone in each of the quarterly data sweeps, with this 5th, and final data set demonstrating that this survival benefit is statistically significant,” stated Michael Tardugno, Celsion’s President and Chief Executive Officer. “This impressive clinical data set, together with prospective supportive preclinical study results and multivariate Cox Regression Analyses, reinforces our confidence in the protocol for our Phase III OPTIMA Study in primary liver cancer, which is evaluating ThermoDox in combination with a standardized RFA protocol in primary liver cancer.”

The HEAT Study and prior post-hoc analyses were presented at multiple medical conferences over the past year, including: the 2014 American Society of Clinical Oncology 50th Annual Meeting in June 2014; the 5th European Conference on Interventional Oncology in April 2014; the International Liver Cancer Association Annual Conference in September 2013; the European Conference on Interventional Oncology in June 2013; and the World Conference on Interventional Oncology in May 2013. Presentations were made by some of the most highly recognized liver cancer researchers and key HEAT Study investigators. Quarterly overall survival data analyses have been conducted with the full support of these researchers and clinical investigators.

The Company notes that,


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