Celsion Reports Unanimous Independent Data Monitoring Committee Recommendation to Continue the Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer
- The Data Monitoring Committee Signals that Patient Safety Data and
Data Quality Meets Expectations and Companyis to Proceed to Next Interim Analysis.
- The Pooled Progression-Free Survival (PFS) Data is Consistent with What Was Observed in the Pooled HEAT Study Subgroup Data. The Pooled HEAT Study Data Demonstrated a Median PFS of 16.8 months While the Latest Pooled OPTIMA Study Data Demonstrates Medium PFS of 17.3 months.
- The Median Follow-Up for Overall Survival is only 25 months at this
Time Pointwhich is Too Early for Estimates.
- A 2nd Pre-Planned Interim Efficacy Analysis is Projected for the 2nd Quarter of 2020 Following 158 Patient Deaths
The iDMC pre-planned interim efficacy review followed 128 patient events, or deaths, which occurred in
The data review demonstrated the following:
- The OPTIMA Study patient demographics and risk factors are consistent with what the Company observed in the HEAT Study subgroup with all data quality metrics meeting expectations.
- Median PFS for the OPTIMA Study reached 17.3 months as of
August 2019. These blinded data compare favorably with 16.8 months median PFS for the 285 patients in the HEAT Study subgroup of patients treated with RFA > 45 minutes and followed prospectively for overall survival.
- At this time point, combined Overall Survival (OS) for both treatment arms is consistent with that observed in the 285 patient prospective HEAT Study subgroup.
- The OPTIMA Study has lost only 4 patients to follow-up from the initiation of the trial in
September 2014through August 2019; the trial design allows for 3% loss per year.
“The hazard ratio for success at 158 events is 0.70. This is below the hazard ratio of 0.65 observed for the 285 patients in the HEAT Study subgroup of patients treated with RFA > 45 minutes,” Mr. Tardugno added.
The iDMC reviews study data at regular intervals, with the primary responsibilities of ensuring the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design.
About the OPTIMA STUDY
The OPTIMA Study was fully enrolled in
Celsion’s most advanced program is a heat-mediated drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox® is positioned for use with multiple heating technologies and has the potential to treat of a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers.
Celsion’s LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. In the first mechanism, rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, ThermoDox® is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. In the second mechanism, when an external heating device heats tumor tissue to a temperature of 40°C or higher, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that can release a chemotherapeutic agent directly into the tumor and the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area subject to tumor invasion, supporting more precise drug targeting.
About Celsion Corporation
Celsion Investor Contact
Executive Vice President and CFO
LHA Investor Relations
Source: Celsion CORP