Celsion Corporation (NASDAQ: CLSN) today announced that updated results from the 701 patient HEAT Study post-hoc analysis, as well as a review of the final study design of the Phase III OPTIMA Study, which both explore ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), or primary liver cancer, were presented at the 5th European Conference on Interventional Oncology (ECIO) on April 24, 2014 in Berlin, Germany. 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 RFA, presented the results and review as part of his Honorary Lecture presentation. The slide presentation will be on the Events and Presentations page on the Celsion website when available.
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Data from the latest HEAT Study post-hoc analysis as of March 31, 2014 suggest that ThermoDox® may markedly improve overall survival, compared to RFA control, in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients (41% of the patients in the HEAT Study). For this subgroup, clinical results indicate a 50% improvement in overall survival, a Hazard Ratio of 0.666 (95% CI 0.434 - 1.022), and a p-Value of 0.06. It is important to note that the median overall survival for this subgroup has not yet been reached.
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"Results from the HEAT Study, among the largest clinical trials conducted in primary liver cancer, highlight the important potential of ThermoDox® in this indication and underscore the need to optimize RFA to achieve a meaningful clinical benefit in overall survival," said Professor Lencioni. "The duration of heat from the RFA procedure appears to be a key factor in successful clinical outcomes when combined with ThermoDox®, as suggested by this large subgroup analysis. To that end, my colleagues in the oncology community and I look forward to exploring an optimized RFA procedure with ThermoDox® in the Phase III OPTIMA Study, with the goal of bringing new treatment options to a rapidly progressing disease whose worldwide incidence is growing at an alarming rate."
"The combination of ThermoDox® and an optimized RFA treatment continues to demonstrate a consistent and impressive improvement in overall survival in HCC patients, as suggested by this and previous data sweeps," stated Dr. Nicholas Borys, Celsion's Chief Medical Officer. "The most recent data, along with supporting multi-variate analyses, point to the importance of optimized RFA as the leading factor in patients with improved overall survival. We look forward to working with the many leading researchers participating in the OPTIMA Study to efficiently enroll the study, and to the potential of providing new treatment options to this underserved patient population."
In addition to the U.S., 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 maintains a strong cash position supporting the OPTIMA Study, last reported at $57 million.
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.
About Celsion Corporation
Celsion is dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license or commercialization agreements with leading institutions, including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford. For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the significant expense, time, and risk of failure of conducting clinical trials; HEAT Study data is subject to further verification and review by the HEAT Study Data Management Committee; the need for Celsion to evaluate its future development plans; termination of the Technology Development Contract or collaboration between Celsion and HISUN at any time; possible acquisitions or licenses of other technologies, assets or businesses or the possible failure to make such acquisitions or licenses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Celsion 's periodic reports and prospectuses filed with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
Investor Contact: Jeffrey W. Church Senior Vice President & Chief Financial Officer609-482-2455 [email protected]
SOURCE Celsion Corporation
