Celsion (CLSN) Offers Updated ThermoDox HEAT Study Data; Notes Robust OS Results

August 15, 2016 8:10 AM EDT

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Celsion Corporation (Nasdaq: CLSN) announced updated results from its final retrospective analysis of the Company's 701-patient HEAT Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC). The overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n= 285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox® and optimized RFA provided an average 54% risk improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 - 0.94) with a p-value of 0.02. Median overall survival for the ThermoDox® group has been reached which translates into a two year survival benefit over the optimized RFA only group (projected to be greater than 80 months for the ThermoDox® plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group).

Additional findings from this most recent analysis specific to the Chinese patient cohort of 223 patients are summarized below:

  • In the population of 154 patients with single lesions (70% of the HEAT Study Chinese patient cohort) who received optimized RFA treatment for 45 minutes or more showed a 53% risk improvement in OS (HR = 0.66) when treated with ThermoDox® plus optimized RFA.
  • These data continue to support and further strengthen ThermoDox®'s potential to significantly improve OS compared to an RFA control in patients with lesions that undergo optimized RFA treatment for 45 minutes or more. The clinical benefit seen in the ITT Chinese patient cohort further confirms the importance of RFA heating time as 72% of patients in this large patient cohort in China received an optimized RFA treatment.

“Data from the HEAT Study have consistently been a foundation and provides additional evidence for our thesis that ThermoDox®, when combined with RFA standardized to a minimum of 45 minutes for intermediate size lesions has the potential to significantly improve survival in primary liver cancer, where the current overall survival rate is far too short,” stated Nicholas Borys, M.D., Celsion's senior vice president and chief medical officer. “These findings, if borne out in our ongoing OPTIMA trial, will position ThermoDox® as a potentially curative treatment in primary liver cancer.”

“We are delighted to present our investors and the medical community with the findings from the final data sweep from the HEAT Study which reinforces the substantial and mounting support for our ongoing global Phase III OPTIMA Study,” said Michael H. Tardugno, Celsion's chairman, president and chief executive officer. “Particularly, with the growing incidence of primary liver cancer in China representing approximately 50% of the 850,000 cases diagnosed annually, the data generated from the Chinese subgroup underscore the importance of ThermoDox® and the role that it will play as a first line therapy for this, the largest unmet medical need in oncology. Along with our China focused manufacturing strategy, the results from the HEAT Study will support our regulatory and long-term commercialization strategy for ThermoDox® in this important region.”

The OPTIMA Study is a pivotal, double-blind, placebo-controlled Phase III clinical trial, and is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of July 31, 2016, the study has been successfully enrolling patients at more than 57 clinical sites in 13 different countries. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 15 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.

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