The Independent Data Monitoring Committee completed a planned analysis of the first half of Celsion's phase III study of ThermoDox, its liver cancer drug.
Here's what you should know:
1. Celsion is studying how ThermoDox when used with radiofrequency ablation can treat liver cancer.
2. The committee found the study is safe for "newly diagnosed, intermediate stage patients," and that researchers are conducting the study safely. The committee recommended the study continue as planned with no modification.
3. ThermoDox has FDA fast track designation. The National Institutes of Health awarded the study priority trial designation.
4. Celsion Chairman, President and CEO Michael Tardugno said in a release, "We are very pleased that the DMC has unanimously recommended continuation of the OPTIMA study based on their review of all available clinical data, both safety and efficacy, in over 275 patients. The DMC's affirmative review is further evidence of ThermoDox's potential to provide a new and important first line therapeutic option for patients with primary liver cancer."