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Celsion Corporation Reports Second Quarter 2014 Financial Results
Date:8/7/2014

ry of DNA and mRNA and TheraSilence™ for delivery of RNA.

Advanced Global Regulatory Efforts in Support of the OPTIMA Study.  During the second quarter, Celsion received regulatory clearance to initiate its Phase III OPTIMA Study evaluating ThermoDox® in combination with optimized radiofrequency ablation (RFA) in patients with primary liver cancer at clinical trial sites in Taiwan, Hong Kong, South Korea, Malaysia and Canada.  Celsion also announced that it has filed Clinical Trial Applications in the Philippines and Thailand, as well as a request for a Voluntary Harmonization Procedure (VHP) in Europe, which provides for the assessment of multinational clinical trial applications across several European countries, including Germany, France and Spain.   The OPTIMA trial is designed to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific and support registration in key liver cancer markets worldwide.

Reported Positive Updated Survival Data from the HEAT Study. In July, Celsion announced updated results from its retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox® in combination with RFA in primary liver cancer. As of June 30, 2014, the latest quarterly Overall Survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the study patients), the combination of ThermoDox® and optimized RFA provided a 57% improvement in OS compared to optimized RFA alone. The Hazard Ratio at this analysis is 0.639 (95% CI  0.419 - 0.974) with a p-value of 0.037. This data provides a strong rationale for the Company's ongoing Phase III OPTIMA Study.

Announced Positive Interim Data from Phase 2 DIGNITY Study. In July, Celsion reported remarkable interim data from its ongoing open-label Phase 2 DIGNITY Trial of ThermoDox® in combination with mild hyperthermiain refractory pat
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