Celsion Corporation (CLSN) announced that after reviewing data from 401 patients enrolled in its pivotal Phase III ThermoDox ® clinical study for primary liver cancer, the Data Monitoring Committee (DMC) has unanimously recommended that the trial continue to enroll patients with the goal of reaching the 600 patients required to complete the study.
The Company previously announced that the U.S. Food and Drug Administration designated the HEAT study of its investigational drug, ThermoDox®, in combination with radiofrequency ablation, as a Fast Track Development Program.
“We are very pleased that the DMC has unanimously recommended continuation of the HEAT study based on its review of all available clinical data, both safety and efficacy, in over 400 patients,” Michael H. Tardugno, Celsion’s President and CEO said in a statement. “The DMC’s affirmative review is further evidence of ThermoDox’s potential to provide a first line of chemotherapy for the treatment of primary liver cancer.”
Shares of Columbia, Maryland – based Celsion were up by 3.36% to $3.08 Thursday morning. The stock has traded as high as $5.63 this year.