Celsion Announces Data Lock for First Interim Analysis in OPTIMA Phase III Study of ThermoDox® in Primary Liver Cancer
Independent Data Monitoring Committee to Meet in October to Evaluate Interim Trial Data
The OPTIMA Study was fully enrolled in
- The OPTIMA patient demographics and risk factors are consistent with what the Company saw in the HEAT Study subgroup and all data quality metrics are meeting expectations.
- Median PFS for the OPTIMA Study had reached 21.2 months as of
October 4, 2018. These blinded, data compare favorably to 16.2 months median PFS for the 285 patients in the subgroup of patients treated with RFA > 45 minutes.
- The OPTIMA Study had lost only three patients to follow-up from the initiation of the trial in
- Blinded data from the intent-to-treat population showed that overall survival thus far is consistent with the HEAT Study subgroup on which the Study’s statistical plan was based.
“Assuming OPTIMA results are similar to the HEAT Study’s prospective subgroup, it is possible, although not probable, for the OPTIMA Study to be declared successful at the first interim analysis. Because the probability of success improves with the number of patients evaluated, a second interim analysis, if necessary, is expected to occur at a minimum of 158 events. The second analysis has a hazard ratio for success of 0.70. While we remain optimistic for a positive trial result in October, the likelihood of success is much greater at the second analysis, which is expected to occur in the first half of 2020,” added Mr. Tardugno.
About the OPTIMA Study
The Phase III OPTIMA Study enrolled 556 patients at 65 clinical sites 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 greater, 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
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials; the uncertainties of and difficulties in analyzing interim clinical data, particularly in small subgroups that are not statistically significant;
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Source: Celsion CORP