LAWRENCEVILLE, N.J., Sept. 2, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that the first patient has been enrolled in its pivotal Phase III OPTIMA Study of ThermoDox® in combination with optimized radiofrequency ablation (RFA) in patients with primary liver cancer, also known as hepatocellular carcinoma (HCC). ThermoDox® is Celsion's proprietary, heat-activated, liposomal encapsulation of doxorubicin.
"There is an urgent need for new treatment options that address primary liver cancer, a rapidly progressing disease with a poor prognosis whose worldwide incidence is growing at an alarming rate," stated Won-Young Tak, M.D., Ph.D. at the Kyungpook National University Hospital in South Korea and Asia Pacific Principal Investigator for the OPTIMA Study. "The OPTIMA Study builds on extensive clinical and preclinical data that point to the potential of ThermoDox®, when combined with an optimized RFA regimen, to significantly improve patient outcomes. I look forward to working with my colleagues to further explore the clinical utility of ThermoDox® in this setting."
The Phase III OPTIMA Study is a global, pivotal, double-blind, placebo-controlled clinical trial that is expected to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific. The study is evaluating ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The primary endpoint for the trial is Overall Survival. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).
As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve Overall Survival compared to a 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. For this group, clinical results indicate a 57% improvement in Overall Survival, a Hazard Ratio of 0.639 (95% CI 0.419 0.974), and a p-value of 0.037.
"Enrollment of the first patient in our pivotal Phase III OPTIMA Study marks a significant milestone in our effort to deliver ThermoDox® as a novel, first-line treatment for patients with primary liver cancer," stated Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The trial 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 optimized RFA. We are now focused on successfully executing the trial, which is designed to establish a clear path to approval in major liver cancer markets worldwide."
About Celsion Corporation
Celsion is a fully-integrated oncology company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies. The Company's lead program is ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in Phase III development for the treatment of primary liver cancer. The pipeline also includes EGEN-001, a DNA-based immunotherapy for the localized treatment of ovarian and brain cancers. Celsion has three platform technologies for the development of novel nucleic acid-based immunotherapies and other anti-cancer DNA or RNA therapies, including TheraPlas, TheraSilence and RAST. 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 uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant; FDA and regulatory uncertainties and risks; the significant expense, time, and risk of failure of conducting clinical trials; the need for Celsion to evaluate its future development plans; 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.
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