X-ray Images from Liver Phase I Trial Presented at Society for Interventional Radiology 33rd Annual Scientific MeetingCOLUMBIA, Md.--(BUSINESS WIRE)--Mar 19, 2008 - CELSION CORPORATION (NASDAQ: CLN) announced today that X-ray (CT) images of liver lesions from its Phase I liver cancer study of ThermoDox in combination with RadioFrequency Ablation treating patients with primary and metastatic liver cancer were presented in an oral paper at the Society for Interventional Radiology 33rd annual scientific meeting in Washington DC. The presentation, entitled "Imaging Features in Patients undergoing Liver RFA plus Heat Deployed Nanoparticles" was delivered by Julia Locklin. The presented images showed differences in the X-ray appearance and size of tumors following treatment with ThermoDox in combination with RadioFrequency Ablation when compared to tumors of other patients treated with RadioFrequency Ablation alone. While this very preliminary finding is promising, these differences will be further assessed in the Company's planned Phase III randomized study comparing Radiofrequency Ablation with Thermodox to Radiofrequency Ablation alone. The Phase III study anticipates imminent enrollment of its first patient.
This Phase I study was carried out under a Cooperative Research and Development Agreement (CRADA) at the National Cancer Institute (NCI) 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, National Cancer Institute (NCI) and Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health (NIH) Clinical Center, and separately 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. 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.
Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "This visual data from our Phase I study may be indicative of ThermoDox clinical activity and this should be conclusively determined in the upcoming Phase III randomized controlled study. We congratulate the ThermoDox investigators from the National Cancer Institute and Queen Mary Hospital for their hard work and dedication."
About ThermoDox(R): ThermoDox(R) is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
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.
For more information on Celsion, visit our website: http://www.celsion.com
THE USE OF THE NAME "NATIONAL CANCER INSTITUTE," "NCI," "NATIONAL INSTITUTES OF HEALTH" OR "NIH" DOES NOT CONSTITUTE DIRECT OR INDIRECT ENDORSEMENT BY THE U.S. GOVERNMENT, OR OF ANY OF ITS ORGANIZATIONAL UNITS OR EMPLOYEES, OF ANY CELSION CORPORATION PRODUCT OR SERVICE.
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.
Paul G. Henning, 212-554-5462
Posted: March 2008