COLUMBIA, MD--(Marketwire - June 07, 2011) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that 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 pivotal, Phase III HEAT study of ThermoDox® in primary liver cancer, will discuss advancements in thermal-based treatments in cancer, including the use of ThermoDox® in combination with radiofrequency ablation (RFA), at the 7th Annual Meeting of the World Conference on Interventional Oncology, which is being held June 9 - 12, 2011 in New York City. Dr. Poon's presentation, titled "Enhancing Ablation: Synergies with Thermal Therapy for Intermediate-Size Tumors," will be held Saturday, June 11th at 4:30 p.m. EDT in Concurrent Session I: Synergies, which will be chaired by HEAT study investigator Riccardo Lencioni, MD, Celsion's Lead Principal Investigator for Europe.
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. The HEAT study, Celsion's most advanced trial, is a multi-national, randomized, double-blind, pivotal trial of ThermoDox® in combination with RFA in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. Patient enrollment in the trial has now reached 95%. The study has been designated as a Priority Trial for liver cancer by the National Institutes of Health, received Fast Track Designation from the FDA and holds Orphan Drug Designation in both the U.S. and Europe. ThermoDox® has also demonstrated efficacy potential in other cancers when used in combination with thermal-based treatment, including recurrent chest wall breast cancer, where it is the subject of an ongoing Phase I/II trial.
"RFA is very effective in small HCC tumors; however in intermediate to large tumors the high local recurrence rate makes RFA less effective," said Dr. Poon. "ThermoDox® has demonstrated the ability to enhance RFA treatment in early studies by expanding its treatment area in a highly targeted manner. This combination holds the potential to confer greater cure rates to larger tumors. I look forward to results of the HEAT study and to evaluating ThermoDox® in other cancers where thermal-based treatment has demonstrated efficacy."
About ThermoDox® and the Phase III HEAT Study
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. In the HEAT Study, ThermoDox® is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5 - 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 76 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with Radio Frequency Ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival (PFS) with a secondary confirmatory endpoint of overall survival. A pre-planned, unblinded interim efficacy analysis will be performed by the independent Data Monitoring Committee when enrollment in the HEAT Study is complete and 190 PFS events are realized in the study population. Additional information on the Company's ThermoDox® clinical studies may be found at www.clinicaltrials.gov.
About Celsion Corporation
Celsion is a leading oncology company dedicated to the development and commercialization of innovative cancer drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Mayo Clinic, the University of Pisa, and the North Shore Long Island Jewish Health System.
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 by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
