CELSION CORPORATION (AMEX: CLN) today announced that a ThermoDox Phase I liver cancer clinical abstract has been accepted for oral presentation at the 2008 Society of Interventional Radiology (SIR) conference. The SIR is hosting this Annual Scientific Meeting in Washington, DC from March 15th to 20th, 2008. This annual meeting provides advances in research, new devices, world-renowned presenters and training fundamentals for medical professionals in the non-surgical field of interventional radiology.
The oral abstract presentation, titled "Imaging Features in Patients Undergoing Liver RFA Plus Heat Deployed Nanoparticles," will report the unique imaging features suggesting improvement in thermal ablation volume with the addition of ThermoDox. The potential clinical significance of these findings support the randomized study in final planning by Celsion.
This Phase I study which 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, NCI and Dr. Bradford J. Wood, Chief, Interventional Radiology Research at the National Institutes of Health Clinical Center 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. 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.
"Celsion is very excited about this announcement and disclosure of imaging features," commented Michael H. Tardugno, Celsion's President and Chief Executive Officer. "While our Phase I liver cancer study was designed to determine the safety profile and dose for future studies, imaging findings arose suggesting increased ablation volume when ThermoDox was used in combination with radiofrequency ablation. This is consistent with our pre-clinical data in that the addition of ThermoDox may improve the effectiveness of RFA (radiofrequency ablation). Dr Wood's abstract is the second clinical abstract to be accepted for oral presentation at a major conference of medical professionals whose interest is in the treatment of this life threatening disease. As we reported earlier, Dr Poon's abstract was also accepted for oral presentation and will be delivered at the IHPBA conference in February 2008.
Our confidence in the promise of ThermoDox and our heat sensitive liposomal technology is reinforced by the recognition of results in line with our expectations in a phase I study. We look forward to the initiation of our pivotal trial now planned for early next year."
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.
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.
