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Invimestrocel - Athersys

Drug Profile

Invimestrocel - Athersys

Alternative Names: Allogeneic stem cell therapy - Athersys; AMI MultiStem; HLCM 051; MultiStem; PF-05285401; PF-5285401

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Athersys
  • Developer Armed Forces Radiobiology Research Institute; Athersys; Case Western Reserve University; Healios; University of Texas Health Science Center at Houston
  • Class Stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease; Adult respiratory distress syndrome
  • New Molecular Entity No
  • Available For Licensing Yes - SARS-CoV-2 acute respiratory disease

Highest Development Phases

  • Phase III Stroke
  • Phase II/III SARS-CoV-2 acute respiratory disease
  • Phase II Adult respiratory distress syndrome; Graft-versus-host disease; Multiple organ failure; Myocardial infarction
  • Preclinical Acute radiation syndrome; Heart failure; Peripheral arterial disorders
  • No development reported Brain injuries; Multiple sclerosis; Spinal cord injuries; Transplant rejection
  • Discontinued Diabetes mellitus; Mucopolysaccharidosis I; Parkinson's disease; Ulcerative colitis

Most Recent Events

  • 10 Oct 2023 Athersys suspends a phase III MASTERS-2 trial in Stroke in the USA and Taiwan (IV, Infusion) due to company intends to conduct additional data analysis with independent statisticians (NCT03545607)
  • 10 Oct 2023 Invimestrocel licensed to Healios worldwide for the treatment of Adult respiratory distress syndrome
  • 18 May 2023 Athersys plans clinical trials with Multistem for Adult-respiratory-distress-syndrome and COVID-2019-infections
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