Celsion Completes Enrollment in Phase I Liver Cancer Study.COLUMBIA, Md. -- CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN) today announced the completion of its Phase I dose escalation study, using ThermoDox([R]), to treat non-resectable liver cancer. The study which was conducted under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) was performed at the National Cancer Institute (NCI See Liberate. ) of the National Institutes of Health, under the leadership of Dr. Steven K. Libutti, Senior Investigator, Head, Tumor Angiogenesis Section, Surgery Branch, Center for Cancer Research, NCI and Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health Clinical Center and at Queen Mary Hospital There are several Queen Mary Hospitals in the world:
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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . 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 liposome (lī`pəsōm', lĭp`ə–), microscopic, fluid-filled pouch whose walls are made of layers of phospholipids identical to the phospholipids that make up cell membranes. technology from Duke University where ThermoDox is also being used in a Phase I clinical study 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 benign prostatic hyperplasia n. Abbr. BPH A nonmalignant enlargement of the prostate gland commonly occurring in men after the age of 50, and sometimes leading to compression of the urethra and obstruction of the flow of urine. 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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