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Pivotal study of cobomarsen for treatment of Adult T-Cell Leukemia/Lymphoma (ATLL)

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Trial Profile

Pivotal study of cobomarsen for treatment of Adult T-Cell Leukemia/Lymphoma (ATLL)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2022

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At a glance

  • Drugs Cobomarsen (Primary)
  • Indications Adult T-cell leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors miRagen Therapeutics; Viridian Therapeutics

Most Recent Events

  • 25 Aug 2020 New trial record
  • 20 Aug 2020 According to a miRagen Therapeutics media release, the company received clear guidance from the FDA on a potential path to registration in this ultra rare indication based upon a small randomized controlled trial with a primary endpoint of progression free survival that is appropriate for a maintenance therapy.
  • 20 Aug 2020 According to a miRagen Therapeutics media release, the company held a Type C meeting with the FDA Office of Oncologic Diseases on August 11, 2020 to discuss the clinical development plans for cobomarsen for the potential treatment of Adult T-Cell Leukemia/Lymphoma (ATLL).

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