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A Phase 3 trial of isaralgagene civaparvovec(ST-920) for the treatment of Fabry disease

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A Phase 3 trial of isaralgagene civaparvovec(ST-920) for the treatment of Fabry disease

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

  • Drugs Isaralgagene civaparvovec (Primary)
  • Indications Fabry's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Sangamo Therapeutics

    • Most Recent Events

    • 08 Aug 2023 According to a Sangamo Therapeutics media release, the company has received productive written feedback from U.S. FDA on proposed Phase 3 trial strategy. The company is Requesting specific additional clarifications before submitting a proposed phase 3 protocol to the FDA, which is expected to be as early as the end of 2023.
    • 26 Apr 2023 According to a Sangamo Therapeutics media release, company plans to meet with the FDA to advance the designing of this study in the summer.
    • 22 Feb 2023 According to a Sangamo Therapeutics media release, trial start anticipated by the end of 2023, depending on regulatory interactions. Dosing of the first patient in the trial could begin as early as the first part of 2024.

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