May 16, 2014
Celsion Corporation Announces ThermoDox® Abstract Accepted at the 2014 American Society of Clinical Oncology 50th Annual Meeting
Abstract Presents a Retrospective Analysis of the Company's 701 Patient HEAT Study and Compelling Data Showing Enhanced Efficacy When Radiofrequency Ablation is Combined with ThermoDox and When Heating Time of the RFA Procedure is Greater Than 45 Minutes
LAWRENCEVILLE, N.J., May 16, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that an abstract on its Phase III HEAT Study of ThermoDox, the Company's proprietary heat-activated liposomal encapsulation of doxorubicin, plus radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC) or primary liver cancer has been accepted for publication at the 2014 ASCO (American Society of Clinical Oncology) meeting in Chicago being held on May 30 - June 3, 2014. The abstract presents a retrospective analysis of the 701 patient HEAT Study and strong, consistent survival data supporting the continued development of ThermoDox in HCC. Celsion will have an exhibit booth (24105) at the ASCO conference.
The abstract, titled "Standardized radiofrequency ablation (sRFA) > 45 minutes plus lyso-thermosensitive liposomal doxorubicin (LTLD) for solitary hepatocellular carcinoma (HCC) lesions 3-7 cm: A retrospective analysis of Phase III HEAT Study," is authored by many of the leading international research and clinical experts in primary liver cancer.
Dr. Nicholas Borys, Celsion's Chief Medical Officer commented, "The HEAT Study abstract selected for publication at ASCO 2014 serves as the basis for our upcoming 550 patient global Phase III OPTIMA Study in hepatocellular carcinoma. This abstract summarizes what we see as compelling data developed from post hoc, multivariate Cox regression analysis. Both unvariate and multivariate analyses suggest that efficacy is considerably enhanced when radiofrequency ablation is combined with ThermoDox and when heating or dwell time of the RFA procedure is greater than 45 minutes. We have worked closely with statisticians, regulators and leading experts in liver cancer to design our global Phase III OPTIMA Study, which we believe establishes a clear path to approval. We are very proud of the strong participation and support of the authors in this study which include many leading international experts in liver cancer. "
In April 2014, Professor Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of Diagnostic Imaging and Intervention at the Pisa University School of Medicine, presented the latest overall survival data from the HEAT Study at the 5th European Conference on Interventional Oncology. As of March 31, 2014, data from the latest HEAT Study post-hoc analysis 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 large subgroup of patients, 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. The survival data emerging from our HEAT Study underscore the potential of ThermoDox in combination with an optimized radiofrequency ablation procedure.
In February 2014, Celsion announced that the U.S. Food and Drug Administration (FDA), following its customary 30 day review, allowed the Company's planned pivotal, double-blind, placebo-controlled Phase III OPTIMA Study. The OPTIMA Study is expected to enroll 550 patients, with up to 100 sites in the United States, Europe, China and Asia Pacific and will evaluate ThermoDox in combination with 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 (OS). The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).
ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. ThermoDox® is being evaluated in a Phase III clinical trial for primary liver cancer and a Phase II clinical trial for recurrent chest wall breast cancer. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by radiofrequency ablation (RFA) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
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 changes in cost and timing of development and testing, capital structure, financial condition, working capital needs and other financial items; 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 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.
Jeffrey W. Church
Senior Vice President and
Chief Financial Officer
SOURCE Celsion Corporation