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A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy

Trial Profile

A Phase IIa, Open-label, Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of BP1001 (a Liposomal Grb2 Antisense Oligonucleotide) in Combination With Venetoclax Plus Decitabine in Patients With AML Who Are Ineligible for Intensive Induction Therapy

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 04 Aug 2023

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At a glance

  • Drugs Decitabine (Primary) ; Prexigebersen (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors Bio-Path Holdings
  • Most Recent Events

    • 01 Aug 2023 According to a Bio-Path Holdings media release, Operations in the United States are expected to remain unchanged with an expected six to ten treatment sites. The company is evaluating whether to seek to expand Stage 2 of the Phase 2 clinical trial by pursuing operations in Europe, as it believes there are more potential patients for Stage 2 of the Phase 2 clinical trial there, which could meaningfully enhance enrollment and accelerate completion of clinical trial milestones.
    • 01 Aug 2023 According to a Bio-Path Holdings media release, the company will conduct an administrative review to affirm the cohorts that will continue with enrollment. Nineteen patients had been chosen as an initial sample size for a cohort to provide interim efficacy data; however, the protocol for the Phase 2 allows Bio-Path to conduct interim efficacy analysis sooner at its discretion.
    • 01 Aug 2023 According to a Bio-Path Holdings media release, based on results from this trial, the company plan to file for regulatory designations that could accelerate our ability to bring this potentially lifesaving therapeutic to patients with the greatest of unmet medical needs.
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