CELSION Provides Update on Status of Special Protocol Assessment (SPA) Submission
Celsion Corporation has received comments this morning from the FDA regarding its September request for a special clinical protocol assessment for its study, "A Phase III, Randomized, Double-Blinded, Dummy-Controlled Study of the Efficacy and Safety of ThermoDox in Combination with Radiofrequency Ablation Compared to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma." The comments from the FDA requested clarifications and recommendations to the study protocol and monitoring. On initial review, Celsion expects to satisfactorily address all of FDA comments and re-submit the protocol for formal special protocol assessment promptly.
"While we are disappointed that another review will be required", commented Michael H. Tardugno, president and chief executive officer of Celsion, "We recognize that the approval mechanism is iterative in nature. We believe the response made by FDA to our submission should not require any significant revisions to the study design. We will continue to work collaboratively with FDA with the intent of starting our study early next year."
The Company expects to discuss FDA's comments and its plans going forward during its third quarter conference call. The Company expects to announce the date and time of its conference call later today.
ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of an approved and frequently used anti-cancer drug, doxorubicin which is used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (39-42 degrees C) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
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. Additional information about Celsion Corporation can be found on the Celsion web site at 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.
Paul G. Henning, 212-554-5462;
Posted: November 2007