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A Phase III, Randomized, Sham-Controlled Study to Evaluate AXO-Lenti-PD in Parkinson's Disease

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Trial Profile

A Phase III, Randomized, Sham-Controlled Study to Evaluate AXO-Lenti-PD in Parkinson's Disease

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2021

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At a glance

  • Drugs AXO Lenti PD (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Oxford BioMedica; Sio Gene Therapies [CEASED]

    • Most Recent Events

    • 29 Oct 2020 According to an Axovant Gene Therapies media release, manufacturing of several GMP batches is now underway and planned at Oxford Biomedica with a goal of generating material for use in future clinical trials as soon as possible and the company expects to provide an update on program timelines in the first quarter of 2021 or as program timelines are clarified.
    • 29 Oct 2020 According to an Axovant Gene Therapies media release, based on new information received from manufacturing partner Oxford Biomedica in mid-October regarding delays in CMC data and third-party fill/finish issues, the development of a suspension-based manufacturing process for AXO-Lenti-PD will take longer than expected. The company believes that it is unlikely hat the trial will enroll patients by the end of calendar year 2021.
    • 08 Apr 2020 According to an Axovant Gene Therapies media release, enrollment of the first randomized subject is expected in 2021.

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