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news.Celsion has reported that its application for a special protocol assessment of the pivotal Phase III primary liver cancer trial has been agreed to by the FDA.
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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 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.
Michael Tardugno, president and CEO of Celsion, said: “We believe that we will enroll our first patient in the study during the first 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 registration studies.”