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A pivotal Phase III trial of GALE-401 in patients with essential thrombocythemia

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Trial Profile

A pivotal Phase III trial of GALE-401 in patients with essential thrombocythemia

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2018

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At a glance

  • Drugs Anagrelide (Primary)
  • Indications Essential thrombocythaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Galena Biopharma; Sellas Life Sciences Group

    • Most Recent Events

    • 29 Dec 2017 According to a Sellas Life Sciences Group media release, SELLAS Life Science Group acquired Galena Biopharma, and subsequently Galena Biopharma changed its name to SELLAS Life Science Group.
    • 11 Sep 2017 According to a Galena Biopharma and BioVascular media release, both Galena Biopharma and BioVascular are responsible for the further development of GALE-401 (Phase 3-ready asset) drug for essential thrombocythemia.
    • 15 Mar 2017 According to a Galena Biopharma media release, after the meeting US FDA confirmed that the GALE-401 development program is appropriate for a NDA filing using the 505(b)(2) regulatory pathway in patients with essential thrombocythemia who are intolerant or resistant to hydroxyurea.
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