Celsion completes enrollment in phase I liver cancer study

The study, which was conducted under a cooperative R&D agreement, was performed at the National Cancer Institute (NCI) of the National Institutes of Health.

In the study, a total of 24 primary and metastatic liver cancer patients, with up to four lesions ranging from three to seven centimeters, were treated with ThermoDox in combination with radiofrequency ablation at doses ranging from 20 to 60mg/m2.

Enrollment in the study has been completed, and clinical data is currently being assembled for analysis and eventual submission for the FDA. While the phase I study was designed to determine the maximum safe dose and safety profile of ThermoDox, additional analyses will be undertaken to evaluate any clinical effects achieved during the study, Celsion said.

Michael Tardugno, Celsion’s president and CEO, commented: “Completion of the liver cancer phase I dosing escalation study represents another milestone in our ThermoDox development program and is consistent with our timelines to initiate our phase III registrational study for primary liver cancer later this year.”

Celsion has licensed the global rights to the temperature-sensitive liposome technology from Duke University where ThermoDox is also being used in a phase I clinical study of patients with recurrent breast cancer on the chest wall under the care of Dr Kim Blackwell, the principal investigator.