Celsion Reaches Major Milestone With Enrollment of 600th Patient in Its Pivotal Phase III HEAT Study of ThermoDox(R) in Primary Liver Cancer
Target Enrollment Achieved; One Trigger Remains for Interim Analysis by Independent Data Monitoring Committee
COLUMBIA, MD -- (MARKET WIRE) -- 08/03/11 --
Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, today announced that it has reached its pre-planned enrollment objective of 600 patients in the Company's pivotal, Phase III HEAT study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radio frequency ablation (RFA) for the treatment of primary liver cancer. The enrollment objective was established to ensure that the study's primary end point, progression-free survival (PFS), can be achieved with adequate statistical power and is one of two triggers for an interim efficacy analysis by the study's independent Data Monitoring Committee (DMC). The second trigger is the confirmation of 190 PFS events in the study population. 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 primary liver cancer by the National Institutes of Health.
"This milestone is a significant accomplishment for the Celsion team and our many collaborators in the global oncology community. Reaching our enrollment objective is also a critical step toward establishing ThermoDox's® potential as a new standard of care in the first line treatment of non-resectable primary liver cancer," said Michael H. Tardugno, President and Chief Executive Officer of Celsion. "As this potential becomes clearer in the coming months, Celsion will take steps toward ensuring a seamless commercialization process for ThermoDox® and the expansion of its clinical development into other indications where it may enhance the efficacy of thermal-based oncology therapies, including recurrent
chest wall breast cancer as well as metastatic liver and bone cancers. With this accomplishment, Celsion remains firmly on a path toward its evolution into a leading oncology drug development company."
"The HEAT study is the largest clinical trial ever conducted in intermediate hepatocellular carcinoma (HCC) and its outcome is greatly anticipated within the medical community. HCC is an aggressive, deadly disease, and one of a few cancers that is growing at an alarming rate throughout the world," added Nicholas Borys, MD, Celsion's Chief Medical Officer. "We believe that adding ThermoDox® to a RFA procedure will dramatically increase the hope for a cure."
The design and statistical plan of the HEAT study incorporate a pre-planned interim efficacy analysis. The HEAT study's independent Data Monitoring Committee will evaluate the unblinded data after the 600 patient target enrollment is reached and 190 PFS events are realized in the study population. The DMC is comprised of an independent group of medical and scientific experts with the responsibility for reviewing and evaluating patient safety and efficacy data from the HEAT study. The interim analysis is intended to evaluate safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study.
Consistent with the Company's global regulatory strategy, Celsion is continuing to enroll patients in the HEAT study in order to randomize at least 200 patients in China, a requirement for registrational filing in China. In addition to meeting the FDA enrollment objective, the HEAT study has also enrolled a sufficient number of patients to support, in Asia, registrational filings in S. Korea and Taiwan, two important markets for ThermoDox®. Continued enrollment will have no effect on the timing for the pre-planned interim analysis, and has the potential to improve the time to final data.
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 is approximately 20,000 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 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 600 patient global Phase III study 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, 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.
Source: Celsion Corporation
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