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A randomized, double-blind, placebo-controlled Phase III study to assess the efficacy and safety of oral arsenic trioxide (OATO) as first-line treatment for cGvHD

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A randomized, double-blind, placebo-controlled Phase III study to assess the efficacy and safety of oral arsenic trioxide (OATO) as first-line treatment for cGvHD

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 07 Oct 2024

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At a glance

  • Drugs Arsenic trioxide (Primary)
  • Indications Graft-versus-host disease
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 30 Sep 2024 According to a BioSenic media release, a phase III study with oral arsenic trioxide in the first-line treatment of cGvHD, for which Medsenic received positive pre-IND response from the FDA, is currently anticipated to start in 2024.
    • 21 Jun 2024 According to BioSenic Media Release, first patient expected to enroll in this study in Q1 2025.
    • 12 Mar 2024 According to BioSenic Media Release, company announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic's forthcoming pivotal Phase 3 clinical trial.

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