LAWRENCEVILLE, NJ--(Marketwire - September 14, 2012) - Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that the independent Data Monitoring Committee (DMC) for the Company's HEAT Study, a fully enrolled, multinational, double-blind, placebo-controlled, pivotal Phase III trial of ThermoDox® in combination with radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC or primary liver cancer), has completed a regularly scheduled review of all 701 patients enrolled in the trial and has unanimously recommended that the HEAT Study continue according to protocol to its final data readout. The HEAT Study is being conducted under a Special Protocol Assessment (SPA) agreed to with the U.S. Food and Drug Administration (FDA).
The primary endpoint for the HEAT Study, progression-free survival (PFS), is defined in the SPA. A total of 380 PFS events are required to reach the unblinding and planned final analysis of the study. Celsion reconfirmed that 380 PFS events are projected to occur in the fourth quarter of 2012, with top line results announced following DMC review and confirmation.
The DMC has reviewed 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. As part of its review of all 701 patients, the DMC monitored a quality matrix relating to the total clinical data set, confirming the timely collection of data, that all data are current as well as other data collection and quality criteria.
"We sincerely thank the DMC for their diligent work in ensuring the quality and consistency of data from all 701 patients in the HEAT Study, as we approach the announcement of top line results," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The HEAT Study is the single largest study ever conducted in intermediate-stage primary liver cancer, the largest unaddressed cancer in oncology today. Celsion is well prepared for the outcome of the HEAT Study, with the regulatory, manufacturing, financial and commercial plans and resources in place to ensure success. We look forward to the next steps for ThermoDox® and remain confident in its potential to provide a new and important therapeutic option for patients with this disease."
The HEAT Study, in addition to being conducted under an 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 provides an acceptable basis for submission of a marketing authorization application (MAA) for centralized review and approval. 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.
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, 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 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.