Data Monitoring Committee Unanimously Recommends Continuation of Celsion Corporation (CLN)''s Phase III ThermoDox(R) HEAT Study to Treat Primary Liver Cancer
COLUMBIA, MD--(Marketwire - 02/11/11) - Celsion Corporation (NASDAQ:CLSN - News), a leading oncology drug development company, today announced that after reviewing data from 482 randomized patients in its multinational, randomized, double-blind, placebo-controlled, pivotal Phase III clinical study of ThermoDox® in combination with radio frequency ablation for primary liver cancer (the HEAT study), the study's Data Monitoring Committee (DMC) has unanimously recommended that the trial continue enrollment. The HEAT study has enrolled over 86% of the 600 patients necessary to ensure that its primary end point, progression free survival, can be achieved with statistical significance.
"The DMC's recommendation to continue enrollment in the HEAT study marks an important milestone for Celsion and ThermoDox®, as it is its final scheduled evaluation ahead of enrollment completion," said Michael H. Tardugno, Celsion's President and Chief Executive Officer. "We remain optimistic and encouraged by this progress and by the potential for ThermoDox® to establish an effective standard of care for the enduring unmet need of patients with primary liver cancer."
The Company further announced that the DMC has maintained its recommendation to continue withholding enrollment of additional patients in Japan pending certain guidance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The recommendation follows a review of safety data from 18 Japanese patients enrolled in the study, when compared to patient data from the rest of the Phase III trial. As a part of its commitment to Japan's PMDA, the DMC independently assesses patients randomized at Japanese sites. As previously noted, overall toxicities for patients in the HEAT study are consistent with doxorubicin's labeled safety profile. Doxorubicin, the active therapeutic in ThermoDox®, is a widely used chemotherapeutic with a well known safety profile and approved globally for use, including Japan, in many cancer indications.
Regarding enrollment in Japan, Mr. Tardugno added: "We will continue working with our Japanese development partner and the DMC toward a timely resolution and the resumption of patient enrollment in Japan. While this process is ongoing, current enrollment in the HEAT study is continuing at 66 sites in ten other countries. We intend to move forward toward enrollment and study completion."
The DMC for the HEAT study 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 Company's Phase III HEAT study. The DMC reviews study data at regular intervals with their primary responsibilities to ensure the safety of all patients enrolled in the trial, the quality of the data collected, and the continued scientific validity of the trial design. The trial design and statistical plan for the HEAT study also incorporates a pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete and 190 progression-free survival events are realized in the study population) with the intent of evaluating safety and efficacy results to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success (a futility analysis) to continue, modify or terminate the trial.
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 750,000 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 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 http://www.clinicaltrials.gov.
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. Contact:
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