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A Phase 1/2a Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis

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Trial Profile

A Phase 1/2a Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Postpolycythemia Vera or Post-essential Thrombocythemia Myelofibrosis

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs PXS 5505A (Primary) ; Ruxolitinib (Primary) ; Janus kinase inhibitors
  • Indications Essential thrombocythaemia; Myelofibrosis; Polycythaemia vera
  • Focus Adverse reactions; Proof of concept
  • Sponsors Syntara Limited

    • Most Recent Events

    • 10 Dec 2024 According to a Syntara media release, After receiving data from a subset of patients reaching 52 weeks of treatment by March 2025, the company intends to discuss with the FDA the trial design for a pivotal Phase 2c/3 study.
    • 10 Dec 2024 According to a Syntara media release, Further interim data will be released in 1H 2025 and final data in 2H 2025.
    • 10 Dec 2024 According to a Syntara media release, Interim data from the study were presented today at the 66th American Society of Hematology annual meeting (ASH)

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