COLUMBIA, Md., Sept. 30 /PRNewswire-FirstCall/ -- Celsion Corporation (Nasdaq: CLSN), a leading oncology drug development company, announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study (the HEAT study) for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study. The Company previously announced that the U.S. Food and Drug Administration (FDA) designated the HEAT study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation (RFA), as a Fast Track Development Program. ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, is currently being evaluated under a Special Protocol Assessment (SPA) agreement with the FDA in this global Phase III trial in patients with non-resectable hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. With nearly 75% of patients enrolled in the trial, Celsion is targeting to complete patient enrollment over the next 4 months. As a part of its commitment to Japan's PMDA, the DMC will continue to independently assess safety in patients randomized at Japanese sites. The goal is to provide data from this cohort sufficient to support immediate registration in Japan following a successful study.
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 ThermoDox 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.
"We are very pleased that the DMC has unanimously recommended continuation of the HEAT study based on its review of all available clinical data, both safety and efficacy, in over 400 patients," stated Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer. "The DMC's affirmative review is further evidence of ThermoDox's potential to provide a first line of chemotherapy for the treatment of primary liver cancer."
The National Institutes of Health and regulatory agencies around the world as well as the liver cancer medical community have all recognized the potential of ThermoDox for the treatment of this unmet medical need as evidenced by the following:
- HEAT study is being conducted under a Special Protocol Assessment with the FDA;
- HEAT study has been granted a Fast Track Designation by the FDA; and
- The National Cancer Institute's recent designation of the HEAT study as a Priority Clinical Trial at its recent Clinical Trial Planning Meeting for HCC.
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 and has a worldwide incidence of approximately 650,000 cases, 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 80% to 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. A thermal zone created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially at the targeted tumor.
For primary liver cancer, ThermoDox® is being evaluated in a 600 patient global Phase III study at 75 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. A pre-planned, interim efficacy analysis will be performed by an independent Data Monitoring Committee when enrollment in the trial is complete and 50 percent of the 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, Cleveland Clinic, 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.
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