LAWRENCEVILLE, NJ, 11 July 2016 – Celsion Corporation (NASDAQ:CLSN) today announced that its ongoing Phase III OPTIMA trial evaluating ThermoDox® in primary liver cancer, also known as hepatocellular carcinoma or HCC, was featured during an oral presentation at the 7th Asia-Pacific Primary Liver Cancer Expert (APPLE) Meeting. ThermoDox® is the Company's proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of HCC.

Soo-Young Park, M.D., Associate Professor, Kyungpook National University, School of Medicine Division of Gastroenterology and Hepatology, delivered the presentation, titled, "Radiofrequency Ablation +/- Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) in Intermediate-Size Hepatocellular Carcinoma: The Ongoing Phase III OPTIMA Study." The OPTIMA Study is an ongoing global, pivotal, double-blind, placebo-controlled clinical trial evaluating ThermoDox® in combination with Radio Frequency Ablation (RFA) standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The study was developed in consultation with leading primary liver cancer, statistical and regulatory experts, and is based on extensive analysis of prior clinical and preclinical studies of ThermoDox® plus standardized RFA.

"The OPTIMA study represents an important study in the field of HCC, one of the most common and deadly cancers worldwide," said Dr. Park. "ThermoDox® plus standardized RFA has the potential to significantly improve overall survival of newly diagnosed patients, and I look forward to working with my colleagues to further advance this trial."
"Data from the earlier HEAT Study suggest that not only does this approach potentially prolong survival, but may also serve as a curative treatment for HCC," stated Won Young Tak, M.D., Professor, Kyungpook National University, School of Medicine, Division of Gastroenterology and Hepatology. "If positive, this study could potentially establish ThermoDox® plus standardized RFA as a first-line treatment for HCC."

In July 2015, Celsion reported the latest overall survival (OS) analysis of the HEAT Study post hoc subgroup. The OS analysis demonstrated that in a large, well bounded, subgroup of patients (n=285 patients, 41% of the previous 701 patient HEAT Study), treatment with a combination of ThermoDox® and standardized RFA (defined as RFA standardized to a minimum of 45 minutes or sRFA > 45 min) provided an average 58% improvement in OS compared to standardized RFA alone. The Hazard Ratio (HR) at this analysis was 0.63 (95% CI 0.43 - 0.93), with a p-value of 0.0198. In this large subgroup, median OS for the ThermoDox® plus standardized RFA group translates into a 25.4 month (more than 2.1 year) survival benefit over the standardized RFA only group - totaling approximately 80 months (6-1/2 years, which is considered a curative treatment for HCC) for the ThermoDox® plus standardized RFA group versus 53.6 months for the standardized RFA only group.

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