In the study, a total of 24 primary and metastatic liver cancer patients, with up to 4 lesions ranging from 3 to 7 centimeters, were treated with ThermoDox in combination with radiofrequency ablation at doses ranging from 20 to 60 mg/m2. Enrollment in the study has been completed, and clinical data is currently being assembled for analysis and eventual submission for the FDA. While the Phase I study was designed to determine the maximum safe dose and safety profile of ThermoDox, additional analyses will be undertaken to evaluate any clinical effects achieved during the study.
Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented "Completion of the liver cancer Phase I dosing escalation study represents another milestone in our ThermoDox development program and is consistent with our timelines to initiate our Phase III registrational study for Primary Liver Cancer later this year."
Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in a Phase I clinical stu dy of patients with recurrent breast cancer on the chest wall under the care of Dr. Kim Blackwell, the principal investigator.
About Celsion: Celsion is dedicated to the development and commercialization of oncology 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, North Shore Long Island Jewish Health System.
Celsion has also developed a microwave based system, the Prolieve Thermodilatation(R) system, for the treatment of benign prostatic hyperplasia which is marketed in the United States under an exclusive distribution agreement with Boston Scientific Corporation. 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.
NO ENDORSEMENT OF CELSION CORPORATION OR ANY OF ITS PRODUCTS OR SERVICES BY THE NATIONAL INSTITUTES OF HEALTH OR THE CLINICAL CENTER IS INTENDED OR SHOULD BE INFERRED.
Tony Deasey, 410-290-5390
Financial Relations Board
Marilynn Meek, 212-827-3773
Susan Garland, 212-827-3775