Celsion Announces Publication of Results of National Institutes of Health (NIH) Analysis of ThermoDox® in Journal of Vascular and Interventional Radiology
NIH’s Independent Analysis of Celsion’s Phase III HEAT Study Confirms Increasing Radiofrequency Ablation (RFA) Heating Time + ThermoDox® Improves Overall Survival with Significance in Patients with Primary Liver Cancer
NIH Analysis Supports the OPTIMA Study Design, Celsion’s Fully Enrolled Global Phase III Study of ThermoDox® to Treat Primary Liver Cancer; First Pre-Planned Efficacy Analysis of the Phase III OPTIMA Study Planned for
The article titled, “RFA Duration Per Tumor Volume May Correlate With Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated With RFA Plus Lyso-thermosensitive Liposomal Doxorubicin,” discussed the NIH analysis of results from 437 patients in the HEAT Study (all patients with a single lesion representing 62.4% of the study population). The key finding was that increased RFA heating time per tumor volume significantly improved overall survival (OS) in patients with single-lesion HCC who were treated with RFA plus ThermoDox®, compared to patients treated with RFA alone. A one-unit increase in RFA duration per tumor volume was shown to result in about a 20% improvement in OS for patients administered ThermoDox®, compared to RFA alone. The authors conclude that increasing RFA heating time in combination with ThermoDox® significantly improves OS and establishes an improvement of over two years versus the control arm when the heating time per milliliter of tumor is greater than 2.5 minutes. This finding is consistent with the Company’s own results, which defined the optimized RFA procedure as a 45-minute treatment for tumors with a diameter of 3 centimeters. Thus, the NIH analysis lends support to the hypothesis underpinning the OPTIMA Study, Celsion’s fully enrolled, on-going Phase III trial in newly diagnosed HCC patients.
“We believe the NIH analysis of Celsion’s HEAT Study validates the importance of combining the proper dose of heat with ThermoDox®,” said
“The dependency of OS on a well-executed RFA procedure was theorized in a prospective review of the data from the HEAT Study,” said
The NIH analysis utilized a specialized image and ablation parameter analysis to determine the burn time per tumor volume for each solitary tumor treated in Celsion’s HEAT Study and then statistically evaluated the relationship between tumor volumes and the RFA duration on patient survival. The results indicated a highly significant quadratic relationship between tumor volume, RFA treatment time, and overall survival. Indeed, the NIH analysis underscores the value of the HEAT Study in establishing a standard approach to planning and conducting RFA treatments based on tumor volumes.
“The findings from the NIH analysis now published in the
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 (RCW) 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 into 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 related to tumor invasion, supporting more precise drug targeting.
About the OPTIMA Study
The Phase III OPTIMA Study has enrolled 556 patients in over 60 clinical sites in
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