FCX 007

Drug Profile

FCX 007

Alternative Names: FCX-007; Fibroblast epidermolysis bullosa cell therapy -Fibrocell/Intrexon; Fibroblast epidermolysis bullosa gene therapy -Fibrocell/Intrexon; Fibroblast recessive dystrophic epidermolysis bullosa cell therapy - Fibrocell/Intrexon; Fibroblast recessive dystrophic epidermolysis bullosa gene thearpy - Fibrocell/Intrexon; Genetically modified human dermal fibroblast-collagen VII; GM-HDF-COL7

Latest Information Update: 09 Jan 2017

Price : $50

At a glance

  • Originator Fibrocell Science
  • Developer Fibrocell Science; Intrexon Corporation
  • Class Cell therapies; Fibroblast cell therapies; Gene therapies; Skin disorder therapies
  • Mechanism of Action Cell replacements; Gene expression modulators; Tissue replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Epidermolysis bullosa
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Epidermolysis bullosa
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Epidermolysis bullosa

Most Recent Events

  • 05 Jan 2017 FCX 007 receives Fast Track designation for Epidermolysis bullosa [Intradermal,Injection] in USA
  • 19 Sep 2016 Fibrocell completes enrolment in the NC1+ cohort of a phase I/II trial for Epidermolysis bullosa in USA
  • 13 Jun 2016 Phase-I/II clinical trials in Epidermolysis bullosa in USA (Intradermal)
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