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A Phase 1, Open-label, Safety, Tolerability, and Efficacy Study of FLT201 in Adult Patients With Gaucher Disease Type 1 (GALILEO-1)

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Trial Profile

A Phase 1, Open-label, Safety, Tolerability, and Efficacy Study of FLT201 in Adult Patients With Gaucher Disease Type 1 (GALILEO-1)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Oct 2024

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At a glance

  • Drugs FLT 201 (Primary)
  • Indications Gaucher's disease type I
  • Focus Adverse reactions; First in man
  • Acronyms GALILEO-1
  • Sponsors Spur Therapeutics

    • Most Recent Events

    • 03 Oct 2024 According to a Spur Therapeutics media release, the company will present data from this study at the European Society of Gene & Cell Therapy (ESGCT) 31st Annual Congress being held October 22-25, 2024, in Rome, Italy. The presentation will be delivered by Francesca Ferrante, MD, Spur therapeutics, on Wednesday, October 23 from 08:30-10:30 a.m. CEST (02:30-04:30 a.m. ET)
    • 07 Aug 2024 Planned primary completion date changed from 30 Nov 2024 to 4 Dec 2024.
    • 08 Jul 2024 According to a Spur Therapeutics media release, based on efficacy and safety data company has selected a single infusion of FLT201 at a low dose of 4.5e11 vg/kg for further development in a Phase 3 trial expected to begin next year.

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