Allogeneic stem cell therapy - Athersys

Drug Profile

Allogeneic stem cell therapy - Athersys

Alternative Names: AMI MultiStem; MultiStem; PF-05285401; PF-5285401

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Athersys
  • Developer Athersys; Case Western Reserve University; MiSOT; University of Texas Health Science Center at Houston
  • Class Antiparkinsonians; Cardiovascular therapies; Heart failure therapies; Stem cell therapies
  • Mechanism of Action Cell replacements; Immunomodulators
  • Orphan Drug Status

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

    Yes - Mucopolysaccharidosis I; Graft-versus-host disease
  • 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.

    Graft-versus-host disease
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Myocardial infarction; Respiratory distress syndrome; Stroke
  • Phase I Graft-versus-host disease; Transplant rejection
  • Preclinical Brain injuries; Diabetes mellitus; Heart failure; Mucopolysaccharidosis I; Multiple sclerosis; Parkinson's disease; Peripheral vascular disorders; Spinal cord injuries
  • Discontinued Ulcerative colitis

Most Recent Events

  • 28 Sep 2016 Atherys receives Special Protocol Assessment designation from the US FDA regarding the registration study design for phase III trial in Stroke in USA
  • 28 Sep 2016 Athersys plans a phase III MASTERS-2 trial for Stroke in USA, Canada and Europe
  • 12 Sep 2016 Additional efficacy data from a phase II trial in Stroke released by Athersys
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