LAWRENCEVILLE, NJ--(Marketwire - April 23, 2012) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today that the independent Data Monitoring Committee (DMC) for the Company's multinational, double-blind, placebo-controlled, pivotal Phase III HEAT Study of ThermoDox® in combination with radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC or primary liver cancer), has completed a review of 652 patients and unanimously recommended that the study continue according to protocol. The DMC reviews study data at regular intervals, with the primary responsibilities of ensuring the safety of all patients enrolled in the study, the quality of the data collected, and the continued scientific validity of the study design.
Celsion also announced today that the HEAT Study achieved its enrollment target in the People's Republic of China (PRC), a key milestone for the Company's global regulatory strategy. The PRC's State Food and Drug Administration (sFDA) requires a minimum of 200 patients for registrational filing in that country.
The HEAT Study remains on track to complete enrollment in the second quarter of 2012. 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 reconfirms that 380 PFS events are projected to occur in late 2012, with top line results announced following DMC review.
"The achievement of our HEAT Study enrollment objective in China is an important milestone for Celsion, as it allows for regulatory filing in a market which accounts for over 50 percent of the 700,000 annual incidences of liver cancer worldwide," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The HEAT Study, the largest company-sponsored study ever conducted in intermediate hepatocellular carcinoma, is rapidly approaching its conclusion. Results from the study remain greatly anticipated within the medical community, and the team at Celsion is working diligently to progress ThermoDox®'s regulatory, commercial, clinical and manufacturing strategies in preparation for potential success."
In the U.S., the HEAT Study is being conducted under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA), has received FDA Fast Track Designation, and has been designated as a Priority Trial for liver cancer by the National Institutes of Health. The European Medicines Agency (EMA) has confirmed the HEAT Study is acceptable as a basis for submission of a marketing authorization application (MAA). ThermoDox® has been granted orphan drug designation in both the U.S. and Europe. 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 South Korea and Taiwan, two 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 700,000 cases per year, 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 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 700 patient global Phase III 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 (PFS) 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, Kyungpook National University Hospital and the Beijing Cancer Hospital. For more information on Celsion, visit our website: http://www.celsion.com.