Celsion Says Recent Analysis Indicates ThermoDox Could Significantly Improve Overall Survival

Celsion Corporation

announced today that Professor Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Diagnostic Imaging and Intervention at the Pisa University School of Medicine in Italy, former ECIO President, current Chairman of the World Conference on Interventional Oncology (WCIO) and Lead European Principal Investigator for Celsion's clinical studies of ThermoDox® plus radiofrequency ablation for the treatment of hepatocellular carcinoma (HCC) or primary liver cancer will, in conjunction with his Honorary Lecture presentation, review the final clinical trial results from the 701 patient HEAT Study post hoc analysis and the rationale for the final study design of the Phase III OPTIMA Study at the 5^th European Conference on Interventional Oncology, which is being held April 23-26, 2014 in Berlin, Germany.  Professor Lencioni is a recognized leader in the use of radiofrequency ablation for HCC which led to the recognition of image-guided ablation as the standard of care for non-surgical patients with early stage HCC in international guidelines.  Most recently, Professor Lencioni has focused on the investigation of the potential synergies between novel therapeutic options and interventional techniques through his participation as a principal investigator in two of the largest global, multi-center trials ever conducted in the field of interventional oncology.  His Honorary Presentation, entitled "20 Years of Interventional Oncology and the Future Trends for 2020", will focus on the lessons learned from past clinical studies and related advances in interventional management.  "I am pleased to present the latest data emerging from the updated analysis from Celsion's Phase III HEAT Study to the European and international interventional oncology community which is suggesting a meaningful clinical benefit in overall survival (OS) in patients who received an optimized RFA procedure," said Professor Lencioni.  "It is important to note that the duration of heat from the RFA procedure appears to be a key factor in a successful clinical outcome when combined with ThermoDox® as suggested by this analysis.  An optimized RFA procedure in combination with ThermoDox® can potentially offer an important new treatment for this underserved patient population." Data from the latest HEAT Study analysis as of December 31, 2013 suggests that ThermoDox® may significantly improve overall survival, compared to control, in patients whose lesions undergo RFA treatment for 45 minutes or more.  These findings apply to patients with single HCC lesions and represent a subgroup of 285 patients (41% of the patients in the HEAT Study).  Updated OS data as of December 31, 2013 from this subgroup of patients is summarized below: o In the patient subgroup treated in the ThermoDox® arm, whose RFA procedure lasted longer than 45 minutes (285 patients or 63% of single lesion patients) clinical results indicate a 55% improvement in overall survival, a Hazard Ratio of 0.64 (95% CI 0.41 - 1.00) and a P-value = 0.0495. Median overall survival for this subgroup has not yet been reached. o In contrast, the patient subgroup treated with ThermoDox® whose RFA procedure lasted less than 45 minutes in duration (167 patients or 37% of single lesion patients) indicated a Hazard Ratio of 1.12 (95% CI 0.68 - 1.86) and a P-value = 0.66.  Median overall survival for this subgroup has not yet been reached. o Multi-variate analysis appears to strongly support the significance of optimized RFA as the leading factor in subjects with improved overall survival.  "The combination of ThermoDox® and an optimized RFA treatment appears to have a significant improvement in overall survival in HCC patients," stated Dr. Nicholas Borys, Celsion's Chief Medical Officer.  "Celsion has been consulting with its key clinical investigators including Professor Lencioni and regulatory and expert statistician consultants regarding the design and clinical protocol for its pivotal Phase III OPTIMA Study."  In addition to the US, Celsion is planning to conduct the OPTIMA Study in up to 100 centers in 14 countries in Asia, Europe and North America, and anticipates patient enrollment in this multicenter global trial to begin in mid-2014.   The Company also notes that, while the data and supporting analysis from the HEAT Study warrant additional clinical development, they should be viewed with caution since they are based on a retrospective analysis and the HEAT Study has not reached its median point for overall survival analysis.  Celsion will continue to follow patients in the HEAT Study to the secondary endpoint, overall survival, and will update the subgroup analysis based on RFA heating duration.