© Reuters. Celsion up 8% on HEAT study publication and therapeutic potential of ThermoDox + RFA
- Celsion (CLSN +8%) perks up on modestly higher volume on the heels of its announcement that a manuscript on its Phase 3 HEAT study assessing ThermoDox plus standardized radiofrequency ablation in hepatocellular carcinoma (HCC) has just been published in Clinical Cancer Research.
- The company says results from the study, data from computer simulations and a post hoc subgroup analysis suggest a clearer understanding of ThermoDox’s heat-based mechanism of action, specifically the longer the tissue is heated, the greater the doxorubicin concentration in tissue.
- The article also explores the hypothesis that ThermoDox combined with radiofrequency ablation (RFA) standardized to a minimum dwell time of 45 minutes may increase overall survival (OS) in HCC patients.
- To test the hypothesis, the company is conducting the Phase 3 OPTIMA study. The primary endpoint is OS over five years. According to ClinicalTrials.gov, the estimated primary completion date is November 2019.
- At the company’s recent R&D Day, investigators presented data that showed a 58% improvement in OS from the ThermoDox/RFA combo compared to RFA alone with 37% less risk of death (hazard ratio = 0.63).
- Now read: Celsion (CLSN) Investor Presentation – Slideshow