Celsion Announces Highlights from Three Presentations Given at the International Liver Cancer Association 2014 Annual Conference

LAWRENCEVILLE, N.J., Sept. 8, 2014 /PRNewswire/ -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced highlights from three presentations by three of the world's leading liver cancer experts and principal investigators for the Company's pivotal Phase III OPTIMA Study of ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with standardized radiofrequency ablation (sRFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC).  The symposium, highly attended by physicians committed to HCC research, was conducted at the International Liver Cancer Association (ILCA) 7^th Annual Conference from September 5 - 7, 2014 in Kyoto, Japan.

The presentations, covering new paradigms in staging HCC patients, Phase III studies in HCC, and advances in image guided radiofrequency ablation, were made on September 6, 2014, during Celsion's symposium on current concepts for treating intermediate HCC. The symposium was moderated by Professor Riccardo Lencioni, MD, FSIR, EBIR, Executive Committee member of the ILCA Governing Board. 

The presentations were made by:

• Ronnie T.P. Poon, MD, MS, PhD, FRCS (Edin), FACS, Professor of Surgery at the University of Hong Kong Queen Mary Hospital, Lead Asia Pacific Principal Investigator for Celsion's Phase III OPTIMA Study and member of the ILCA Governing Board.

Professor Poon's presentation, titled "New Paradigms in Staging HCC: BCLC vs. Hong Kong Liver Cancer Staging System (HKLS)," covered a more aggressive strategy for treating different stages of HCC. Intermediate stage HCC may be curable with RFA and combining sRFA with ThermoDox® may enhance the cure rate.

• Richard S. Finn, MD, faculty at the Division of Hermatology and Oncology and Director of the Translational Oncology Research Laboratory at UCLA, North American Principal Investigator for Celsion's Phase III OPTIMA Study and member of the ILCA Governing Board.

Dr. Finn's presentation, titled "Phase III Studies in Intermediate Stage HCC: What Have We Learned From Recent Failures?" reviewed results from recent Phase III clinical studies in intermediate stage HCC patients including recent overall survival data from Celsion's Phase III HEAT Study post-hoc analysis, noting a subgroup of significant size, strongly suggests positive Overall Survival (OS) in ThermoDox® treated patients when heating cycles from the radiofrequency ablation (RFA) procedure were optimized.

As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to show 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.

• Riccardo Lencioni, MD, FSIR, EBIR, Professor and Director of the Division of Diagnostic Imaging and Intervention at Pisa University School of Medicine in Pisa, Italy and Lead European Principal Investigator for Celsion's Phase III OPTIMA Study.

Dr. Lencioni's presentation, titled "Image Guided Ablations: Current Status and Future Prospects," reviewed findings from the HEAT Study post-hoc analysis which strongly support the rationale for a minimum 45 minute ablation time when using ThermoDox®.  The findings from the HEAT study suggest that there could be an important curative role for RFA and ThermoDox® in intermediate HCC if a 45 minute heating time is applied.

"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 underscores the need to standardize RFA with ThermoDox®," said Professor Lencioni.  "The HEAT Study clearly demonstrated that there is a place for RFA in treating intermediate HCC and standardizing RFA with ThermoDox®, as in Celsion's OPTIMA Study, may be the key to a curative treatment for this deadly cancer."

The three presentations are available on Celsion's website at http://investor.celsion.com/events.cfm. 

About The International Liver Cancer Association

The International Liver Cancer Association is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines – medical, interventional and surgical oncology as well as hepatology.  ILCA's Executive Committee consists of Dr. Peter R. Galle, Professor Riccardo Lencioni and Dr. Morris Sherman. Celsion noted that Professor Lencioni and Poon and Dr. Sherman and Finn are participating in the Company's Phase III OPTIMA Study.

About Celsion's Phase III OPTIMA Study

Celsion's Phase III OPTIMA Study is a global pivotal, double-blind, placebo-controlled study evaluating ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation (RFA) in HCC. The study is expected to enroll 550 patients globally, with up to 100 sites in the United States, Europe, China and Asia Pacific.

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.

Celsion Investor Contact

Jeffrey W. Church
Sr. Vice President and CFO
609-482-2455
[email protected]

SOURCE Celsion Corporation