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A Phase III, open label, multi-centered, intra-patient controlled trial of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Trial Profile

A Phase III, open label, multi-centered, intra-patient controlled trial of FCX-007 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2019

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At a glance

  • Drugs FCX 007 (Primary)
  • Indications Epidermolysis bullosa
  • Focus Registrational; Therapeutic Use
  • Acronyms DEFI-RDEB
  • Sponsors Fibrocell Science
  • Most Recent Events

    • 20 Aug 2019 According to a Fibrocell Science media release, Based on guidance from a Type C meeting and a Type B end-of-Phase 2 meeting with the FDA on the design of this trial, the company has updated he Chemistry, Manufacturing and Controls (CMC) information filed to the Investigational New Drug (IND) application for FCX-007 in early July 2019.
    • 31 Jul 2019 Status changed from planning to recruiting , according to a Fibrocell Science media release.
    • 15 May 2019 According to a Fibrocell Science media release, the company projects enrollment and dosing of Phase 3 patients will be completed in the third quarter of 2020 and data collection for the primary endpoint will be completed in the fourth quarter of 2020. If the Phase 3 clinical trial is successful and completed within the projected timeframe, Fibrocell expects to file a BLA for FCX-007 in 2021.
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