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VITAL: A Pivotal Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) (GENE TRANSFER)

Trial Profile

VITAL: A Pivotal Phase 3 Study of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) (GENE TRANSFER)

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs EB 101 (Primary)
  • Indications Epidermolysis bullosa
  • Focus Registrational; Therapeutic Use
  • Acronyms VIITAL; VITAL
  • Sponsors Abeona therapeutics
  • Most Recent Events

    • 12 Nov 2019 According to an Abeona Therapeutics media release, the company has submitted additional transport stability data as well as clinical trial protocol with updated PRO assessments and the retrovirus comparability protocol of this study to FDA in response to clinical hold letter.
    • 23 Sep 2019 According to an Abeona Therapeutics media release, the company has been working closely with the FDA to gather supplemental data points on transport stability of EB-101 and they are confident that the requested additional data will be submitted to the FDA promptly. The completion of CMC work coupled with the durable safety and efficacy data will ultimately be critical to support a future Biologics License Application.
    • 23 Sep 2019 Status changed from not yet recruiting to suspended, according to an Abeona Therapeutics media release.
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