LAWRENCEVILLE, NJ, 21 June 2016 – Celsion Corporation (NASDAQ:CLSN) today announced publication of the article, "RFA plus lyso-thermosensitive liposomal doxorubicin: In search of the optimal approach to cure intermediate-size hepatocellular carcinoma," in Hepatic Oncology, a peer-reviewed medical journal. The article provides a comprehensive overview of the clinical evaluation conducted to date of lyso-thermosensitive liposomal doxorubicin (LTLD), Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of primary liver cancer, also known as hepatocellular carcinoma or HCC. The article details learnings from the Company's 701 patient HEAT Study, a computational modeling study, an experimental animal study and the HEAT Study post hoc subgroup analysis, all of which are consistent with each other and which -- when examined together -- suggest a clearer understanding of a key LTLD heat-based mechanism of action: the longer the target tissue is heated, the greater the doxorubicin tissue concentration. Additionally, the article explores a new hypothesis prompted by these findings: LTLD, when used in combination with Radio Frequency Ablation (RFA) standardized to a minimum dwell time of 45 minutes (sRFA > 45 min), may increase the overall survival (OS) of patients with HCC. Written by Riccardo Lencioni, MD and Dania Cioni, MD of the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine in Miami, Florida, the article is published in the June 10, 2016 issue of the journal, Hepatic Oncology.
"There is an urgent need for new and better treatment options for HCC, the sixth most common cancer in the world, and the third most common cause of death from malignant disease," noted Michael H. Tardugno, Celsion's chairman, president and chief executive officer, in response to the article's publication. "We believe strongly that ThermoDox® may be an important new approach to the treatment of HCC. We are also now committed to learning more about how an LTLD regimen may prolong the survival of patients suffering from this extremely deadly cancer," Mr. Tardugno added.
Interest in ThermoDox® as a potential treatment option for HCC increased markedly among liver cancer experts worldwide following the announcement by Celsion in July 2015 of the latest OS analysis of the HEAT Study post hoc subgroup. According to this announcement, this most current 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 Radio Frequency Ablation 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 is 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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