Data Monitoring Committee Completes Mid-Study Review of Celsion's Phase III ThermoDox® OPTIMA Study in Primary Liver Cancer
OPTIMA Study at Over 60% Patient Enrollment, DMC Provides Unanimous Recommendation to Continue
Celsion Summarizes Regulatory Strategy for ThermoDox®
The DMC is comprised of an independent group of medical and scientific experts and is responsible for reviewing and evaluating patient safety and efficacy data for the Company's Phase III OPTIMA Study. The DMC reviews study data at regular intervals in order to ensure the safety of all patients enrolled in the trial and to monitor the quality and overall conduct of the trial including each site's compliance with the minimum RFA heating time of 45 minutes specified in the study protocol. The Company also announced that enrollment in the OPTIMA Study is now over 60% of the 550 patients necessary to ensure that its primary end point, overall survival, can be achieved with statistical significance.
"Following independent confirmation of our hypothesis by the
"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," stated Mr.
Regulatory Strategy for ThermoDox®. ThermoDox® has received FDA Fast Track Designation and in the prior HEAT Study had been designated as a Priority Trial for primary liver cancer by the
The OPTIMA study's design and statistical plan incorporates two pre-planned interim efficacy analysis by the DMC (after patient enrollment is complete) with the intent of evaluating safety, efficacy and futility to determine if there is overwhelming evidence of clinical benefit or a low probability of treatment success to continue, modify or terminate the study. The results from the first interim efficacy analysis are expected to be made public following DMC review in Q1 of 2019.
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 70 clinical sites in
About Celsion Corporation
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Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 firstname.lastname@example.org
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