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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy

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Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Jun 2024

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At a glance

  • Drugs Deramiocel (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms HOPE-2
  • Sponsors Capricor Therapeutics
  • Most Recent Events

    • 11 Jun 2024 According to a Capricor Therapeutics media release, FDA has agreed to a pre-BLA meeting based on their review of clinical data from HOPE-2, HOPE-2 open label extension (OLE) and available data from HOPE-3. The company plans to initiate BLA filing with a rolling submission in the third quarter of 2024 and plans to further outline the submission schedule with the FDA in the coming months.
    • 04 Jun 2024 According to a Capricor Therapeutics media release, topline results from this trial expected in the fourth quarter of 2024.
    • 04 Jun 2024 According to a Capricor Therapeutics media release, company shared the results of this rial at Type-B meeting with the U.S. Food and Drug Administration (FDA), to support what company expect to see in the HOPE-3 pivotal study to continue to work on strategies for the most expeditious pathway to potential BLA approval and commercialization.
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