Celsion Announces ThermoDox® HEAT Study Findings to be Reviewed at the 9th Annual World Conference on Interventional Oncology (WCIO) in New York City on May 16, 2013
LAWRENCEVILLE, N.J., May 1, 2013 /PRNewswire/ — Celsion Corporation (NASDAQ: CLSN) announced today that Professor Riccardo Lencioni, MD, FSIR, EBIR, 2013 WCIO Program Chairman and the Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Italy and Lead European Principal Investigator for Celsion’s Phase III HEAT Study and Ronnie T.P. Poon, MD, MS, PhD, FRCS(Edin), FACS, Professor of Surgery at the University of Hong Kong and Lead Asia Pacific Principal Investigator for Celsion’s Phase III HEAT Study will, in conjunction with their scientific presentations, review the clinical trial results including new emerging findings from the HEAT Study post hoc analysis at the 9(th) Annual Meeting of the World Conference on Interventional Oncology, which is being held May 16 – 20, 2013 in New York City. The Company recently reported, based on the post hoc analysis, that ThermoDox® in combination with radiofrequency ablation (RFA) markedly improved progression free survival (PFS) and overall survival (OS) in patients who had optimal RFA. Dr. Lencioni’s presentation, titled “Advances in Image-Guided Ablation” will be held Thursday, May 16, 2013 at 11:00 a.m. EDT in Plenary Session: Multidisciplinary State-of-the Art: HCC and Professor Poon’s presentation, titled “Thermally Sensitive Drug Carriers” will be held Thursday, May 16, 2013 at 4:30 p.m. EDT in Concurrent Session: New Drugs/New Carriers/New Devices.
Celsion has conducted a comprehensive analysis of the data from the Phase III HEAT Study of ThermoDox® in hepatocellular carcinoma (HCC) with key principal investigators, data experts and liver cancer experts including Professors Lencioni and Poon. This analysis followed the announcement on January 31, 2013, that ThermoDox® in combination with RFA did not meet the Study’s primary endpoint. Emerging data from the HEAT Study post hoc analysis demonstrates that ThermoDox® markedly improves progression free survival (PFS) and overall survival (OS) in patients if their lesions undergo RFA for 45 minutes or more. These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of patients.
“The HEAT Study is the largest clinical trial ever conducted in the field of image-guided ablation of HCC; as such, there is a trove of important data emerging from this study regarding the use of ThermoDox® in conjunction with RFA to treat this serious, deadly cancer,” said Professor Lencioni. “I am pleased to introduce this analysis of a large subgroup which may be indicating a meaningful clinical benefit in both PFS and overall survival at WCIO. The details of the data will be presented for peer review at upcoming scientific meetings. It is important to note that the duration of heat from the RFA procedure appears to be a key factor in a successful clinical outcome when combined with ThermoDox® as suggested by this analysis. These findings are consistent with our understanding of how RFA plus ThermoDox® can potentially offer an important new treatment for this underserved patient population.”
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.
Jeffrey W. Church
Sr. Vice President – Corporate
Strategy and Investor Relations
SOURCE Celsion Corporation