Monday, November 20, 2017

© Reuters.  Celsion up 8% on HEAT study publication and therapeutic potential of ThermoDox + RFA© 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

Original article

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