Columbia, MD January 22, 2007: CELSION CORPORATION (AMEX: CLN) today reported that Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health's National Cancer Institute presented the progress of a Phase I dose escalation study, using ThermoDox, to treat unresectable liver cancer. ThermoDox, a heat activated liposomal formulation of doxorubicin, in conjunction with Radiofrequency Ablation (RFA) was used with limited and manageable toxicity to treat 22 patients, 8 with primary hepatocellular carcinoma and 14 with metastatic liver cancer, at doses of up to 60 mg/m². The study is being performed at the National Cancer Institute (NCI) as part of a Cooperative Research and Development Agreement (CRADA), under the leadership of Dr. Wood and Dr. Steven K. Libutti, Senior Investigator, Head, Tumor Angiogenesis Section, Surgery Branch, CCR, NCI; and at Queen Mary Hospital in Hong Kong under the leadership of Dr. Ronnie T.P. Poon, MD, Professor of Surgery, Faculty of Medicine at Queen Mary Hospital, University of Hong Kong. Dr. Wood presented the abstract and poster at the ASCO-GI meeting in Orlando, Florida.
In the study, patients with up to 4 lesions ranging from 3 to 7 centimeters are eligible to receive ThermoDox at doses ranging from 20 to 70 mg/m². The effect of the treatment on the diameter of the lesions is followed using MRI, PET and contrast enhanced CT scans taken pre-treatment and at one and three months post-treatment. Lesion diameters will be compared to those of other patients treated with RFA alone. This study, being carried out by Celsion and the NCI continues to enroll patients into the 60 mg/m² treatment cohort.
Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in this Phase I clinical study of patients with recurrent chest wall breast cancer under the care of Dr. Kim Blackwell, the principal investigator.
Dr. William Hahne, Celsion's Vice President of Research and Development, commented "We are pleased that dose in this study continues to escalate safely as clinical evidence suggests that a higher dose should result in increased efficacy. We are continuing to work with the FDA to finalize endpoints for a Phase III study in primary liver cancer, to be conducted by Celsion, in which we expect to initiate enrollment in 2007. This work will be used to refine tumor targeting and ultimately to improve the efficacy of drugs using our heat activated delivery system."
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, Massachusetts Institute of Technology, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University..
Celsion has also developed a microwave based system, the Prolieve Thermodilatation® 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.
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