Data Monitoring Committee (DMC) Completes Planned Safety and Data Review of Celsion’s Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer
Blinded Progression-Free Survival (PFS) Rate in the OPTIMA Study is Consistent With the Subgroup Patient Population That Showed Benefit in the HEAT Study
ThermoDox®-Highlighted Symposium, “Emerging Horizons in HCC: From Palliation to Cure,” on
"The DMC’s latest recommendation to continue the ongoing OPTIMA Study further supports our confidence in ThermoDox® and the OPTIMA Study’s design to demonstrate the safety and effectiveness of ThermoDox® plus standardized RFA therapy in the treatment of patients with primary liver cancer,” said
The DMC consists of an independent group of medical and scientific experts 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, which is specified in the study protocol.
The OPTIMA Study's design and statistical plan incorporates two pre-planned interim efficacy analyses by the DMC 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.
“This DMC analysis was the last planned interim analysis prior to enrollment completion in the OPTIMA Study, and it represents another important milestone in our ThermoDox® development program,” said
Hepatocellular Carcinoma (HCC) Symposium at
The slides from Prof. Lencioni’s presentation, “Rethinking Our Approach to Intermediate-Size HCC,” will be available on Celsion’s corporate website at www.celsion.com following the symposium on
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
ThermoDox is a registered trademark of
Celsion Investor Contact
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 firstname.lastname@example.org
Source: Celsion Corporation