LAWRENCEVILLE, NJ--(Marketwire - May 30, 2012) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it has reached its enrollment objective of 700 patients in the Company's pivotal, Phase III HEAT Study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of hepatocellular carcinoma (HCC), also known as primary liver cancer. The primary endpoint for the study is progression-free survival (PFS), and a total of 380 events of progression are required to reach the planned final analysis of the study. Celsion notes that 380 PFS events are projected to occur in late 2012. Top line results will be announced following review by the Company's independent Data Monitoring Committee.
"Completion of enrollment in the HEAT Study is yet another important milestone for Celsion; marking the conclusion of the execution phase in this multi-year study," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "ThermoDox®, we believe, has enormous potential as an adjunct to heat-based treatment modalities that are an increasingly important subject of research for controlling disease in oncology. This potential is what makes ThermoDox® among the most promising new therapeutic candidates in oncology today. The HEAT Study, as the largest study ever conducted in intermediate hepatocellular carcinoma, is a critical point of validation for our drug technology and our company. We look forward to the study's outcome, and to continuing our efforts -- in anticipation of potential success -- to advance our regulatory, commercial, clinical and manufacturing strategies."
"With enrollment now complete, Celsion expects development costs to begin decreasing over the next several quarters ahead of unblinding of the HEAT Study," noted Gregory Weaver, Celsion's Chief Financial Officer. "The Company continues to project that reduction in expenses will allow sufficient cash to fund operations through to the third quarter of 2013, providing Celsion with capital through key data milestones."
The HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, has received FDA Fast Track Designation and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. ThermoDox® has been granted orphan drug designation in both the U.S. and Europe. The European Medicines Agency (EMA) has confirmed the HEAT Study is acceptable as a basis for submission of a marketing authorization application (MAA). In addition to meeting the U.S. FDA and European EMA enrollment objectives, the HEAT Study has also enrolled a sufficient number of patients to support registrational filings in China, South Korea and Taiwan, three other large and important markets for ThermoDox®.
About Primary Liver Cancer
Primary liver cancer is one of the most deadly forms of cancer and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer today is approximately 26,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 750,000 cases per year, 55 percent of which are in China, due to the high prevalence of Hepatitis B and C in developing countries. The World Health Organization estimates that primary liver cancer may become the number one cancer worldwide, surpassing lung cancer, by 2020.
The standard first-line treatment for liver cancer is surgical resection of the tumor; however, 90% of patients are ineligible for surgery. Radio frequency ablation (RFA) has increasingly become the standard of care for non-resectable liver tumors, but the treatment becomes less effective for larger tumors. There are few non-surgical therapeutic treatment options available, as radiation therapy and chemotherapy are largely ineffective in the treatment of primary liver cancer.
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 Radio Frequency Ablation (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 global, multi-center, randomized, pivotal Phase III HEAT Study at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival with a secondary confirmatory endpoint of overall survival. 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 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 and the Beijing Cancer Hospital.
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.