Columbia, MD November 30, 2005: CELSION CORPORATION (AMEX: CLN) today announced that two studies involving the investigation of ThermoDox in animals will be presented at the 2005 Annual Radiological Society of North America meeting in Chicago (November 27 to December 2, 2005).
In the first study to be presented by Victor Frenkel, PhD of the National Institutes of Health (NIH), ThermoDox (heat sensitive liposomal doxorubicin) administered in combination with pulsed High Intensity Focused Ultrasound (HIFU), as an activating heat source, significantly increased doxorubicin concentrations in tumors grown in mice by comparison to the combination of HIFU with Doxil®, a non-heat sensitive liposomal formulation of doxorubicin.
In the second animal study, to be presented by Sergio Dromi M.D. of the NIH, ThermoDox combined with Radiofrequency Ablation (RFA), as an activating heat source, given to dogs increased the size and fibrin deposition in the target thermal lesions created by RFA compared to the application of RFA alone. No other important liver or systemic toxicity was observed in the animals tested with RFA and ThermoDox.
Both studies were supported, in part, under a collaborative research and development agreement between the NIH and Celsion Corporation.
Celsion is currently sponsoring a phase I dose escalation study using ThermoDox in combination with RFA to treat liver cancer. The study is presently underway at the National Cancer Institute under the supervision of principal investigators Dr. Steve Libutti and Dr. Bradford Wood. Celsion also recently announced that it is funding a phase I dose escalation study at Duke University for the treatment of local-regionally advanced breast cancer. Patient enrollment in this study is expected to start early in 2006.
Dr. Lawrence Olanoff, Celsion's President and Chief Executive Officer, commented, "These studies are very encouraging, in that they further demonstrate the unique ability of heat activated liposomal systems to effectively target high concentrations of drug to a specific organ and to enhance the action of thermoablative therapy. The results reinforce our belief that the proprietary heat activated liposome in which we have encapsulated doxorubicin to produce ThermoDox could be a platform upon which we can ultimately build a range of different oncology drugs. It remains Celsion's goal to devote our development efforts to improving the utility of cancer chemotherapeutic agents through their encapsulation in heat sensitive liposomes which can be activated at target organ sites by clinically available thermotherapy devices."
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. 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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