Item 8.01 Other Events
On July 13, 2020, Celsion Corporation (the "Company") issued a press release
announcing that it had received a recommendation from the independent Data
Monitoring Committee (the "DMC") to consider stopping the Phase III OPTIMA Study
of ThermoDox® in combination with radiofrequency ablation for the treatment of
hepatocellular carcinoma, or primary liver cancer (the "Study"). As further
described below and in the press release, this recommendation is based on the
July 9, 2020 pre-planned interim safety and efficacy analysis conducted by the
DMC.
The recommendation was made following the second pre-planned interim safety and
efficacy analysis by the DMC on July 9, 2020. The DMC analysis found that the
pre-specified boundary for stopping the trial for futility of 0.900 was crossed
with an actual value of 0.903. However, the 2-sided p-value of 0.524 for this
analysis provides uncertainty, subsequently, the DMC has left the final decision
of whether to stop the OPTIMA Study to Celsion. There were no safety concerns
noted during the interim analysis. A copy of the press release is attached
hereto as Exhibit 99.1, and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
99.1 Press Release, dated July 13, 2020, announcing the DMC
recommendation
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