Columbia, MD - January 18, 2008: CELSION CORPORATION (AMEX: CLN) today announced that its application for a Special Protocol Assessment (SPA) for its Pivotal Phase III Primary Liver Cancer trial has been agreed to by the US Food and Drug Administration. With this agreement, Celsion will begin immediate implementation of the study which has been planned in detail during the course of FDA's review. The study is designed to demonstrate the efficacy of Celsion's proprietary chemotherapeutic, ThermoDox, in combination with radiofrequency ablation as a first line treatment of primary liver cancer, the fifth largest cancer globally with an incidence of over 650,000 cases annually. The study will incorporate about 40 clinical sites in North America, Italy, China, Taiwan, Hong Kong, and Korea, and is planned to enroll 600 patients and specifies the primary end point as Progression Free Survival.
Mr. Michael H. Tardugno, Celsion's President and Chief Executive Officer, commented, "FDA's approval of our study allows Celsion to take a very important step forward in our goal to bring ThermoDox to market for the benefit of patients with this devastating and life threatening disease. Our work thus far has been very encouraging. Strong evidence of clinical activity gives us every reason to believe that our proprietary heat sensitive tumor targeting technology will provide an important treatment option for primary liver cancer"
Mr. Tardugno further commented, "I would like to acknowledge the positive collaboration we've had with the FDA during this process. Our SPA has resulted in a design and structure of an excellent quality phase III program. Celsion's commitment to the rapid start up of a high quality study is uncompromised. During FDA's review of our SPA application, our clinical team and CRO partners have planned a detailed phase III launch and execution. We are well positioned and believe that we will enroll our first patient in the study during the 1st Quarter of 2008."
"With affirmation from the Agency that our planned open label Phase II Pivotal Study for Recurrent Chest Wall (RCW) cancer would support an NDA application, Celsion now has agreement for two registrational studies, concluded Mr. Tardugno. "Having either would be a transformational event for the Company; having both indications given the go-ahead by the FDA speaks to the promise and potential of ThermoDox and the solid work and commitment of our management and scientific team."
ThermoDox 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 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.
For Further Information Contact:
Paul G. Henning