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An Actimab-MDS Pivotal Trial Enabling Study for Targeted Conditioning in All High-Risk Myelodysplastic Syndrome (MDS) with Poor or Very Poor and Complex Cytogenetics

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Trial Profile

An Actimab-MDS Pivotal Trial Enabling Study for Targeted Conditioning in All High-Risk Myelodysplastic Syndrome (MDS) with Poor or Very Poor and Complex Cytogenetics

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2019

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At a glance

  • Drugs Lintuzumab Ac-225 (Primary) ; Fludarabine; Melphalan
  • Indications Myelodysplastic syndromes
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Actinium Pharmaceuticals

    • Most Recent Events

    • 15 Mar 2019 According to an Actinium Pharmaceuticals media release, the company expects to initiate this study in 2019
    • 15 Mar 2019 According to an Actinium Pharmaceuticals media release, the companys recent patent filings pertain to this planned pivotal Actimab-MDS targeted conditioning trial, ARC combination trials of Actimab-A with venetoclax (CT profiles 304368 and 305494) and CLAG-M (292912), as well as its next-generation ARCs resulting from its AWE or Antibody Warhead Enabling Technology Platform.
    • 30 Oct 2018 According to an Actinium Pharmaceuticals media release, initial proposal to the FDA was to conduct a larger Phase 2 trial prior to a pivotal trial in patients with a TP53 mutation, however, the company was encouraged by the FDA to expand the trial to include all high-risk patients with poor or very poor and complex cytogenetics.

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