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Clinical Trials

Date: 2014-12-01

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in San Francisco, California from December 6-9, 2014.

Company: Cell Therapeutics, now CTI Biopharma (USA - WA) Cancer Research UK (UK) Cardiff University (UK)

Product: pacritinib

Action mechanism:

tyrosine kinase inhibitor. Pacritinib is an oral JAK2/FLT3 inhibitor that has demonstrated encouraging activity in preclinical models of AML with mutated FLT3 gene, including additional FLT3 mutations that confer resistance to other targeted FLT3 agents.

Disease: relapsed acute myeloid leukemia (AML) with mutations of the FLT3 gene

Therapeutic area: Cancer - Oncology

Country: UK

Trial details:

The trial is being conducted by the AML Working Group of the National Cancer Research Institute Haematological Oncology Study Group in Acute Myeloid Leukemia (AML) and high risk Myelodysplastic Syndrome (MDS) under the sponsorship of Cardiff University and supported by Cancer Research UK. The trial management group is lead by Professor Alan K. Burnett, Head of Haematology in the Department of Medical Genetics, Haematology and Pathology at the School of Medicine at Cardiff University.
This Phase 2 trial is part of a larger ongoing study in AML, referred to as the AML17 trial, which includes multiple arms evaluating first line regimens for AML. Patients with the FLT3 mutation, who are enrolled in this study and relapse following standard therapy, will be offered therapy with pacritinib. Approximately 80 patients at sites in England and Wales will be enrolled and, if an encouraging response rate is observed, a pacritinib arm may be adopted in the first line therapy study.

Latest news:

  • • On December 1, 2014, CTI BioPharma announced the upcoming presentations of data highlighting pacritinib, an oral multikinase inhibitor with dual activity against JAK2 and FLT3, at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6-9 in San Francisco, CA. The presentations include data on the activity of pacritinib in stroma adherent acute myeloid leukemia (AML) cells, a profile of kinase inhibition across several cell signaling pathways with pacritinib treatment. Pacritinib Suppresses Leukemic Outgrowth from FLT3-ITD Positive Stroma-Adherent Primary AML Cells. First Author: Ceri Marrin, MBBCh, Department of Haematology, Institute of Cancer & Genetics, Cardiff University, Cardiff, United Kingdom (Abstract #270)
  • • On January 30, 2014, Cell Therapeutics has announced the initiation of an international cooperative group Phase 2 clinical trial of pacritinib in adult patients with relapsed acute myeloid leukemia (AML) with mutations of the FLT3 gene. Mutation of the FLT3 gene is found in approximately one-third of AML patients and is an independent risk factor for poor prognosis. In November 2013, CTI and Baxter International entered into a worldwide license agreement to develop and commercialize pacritinib in which CTI and Baxter will jointly commercialize pacritinib in the United States and Baxter has exclusive commercialization rights for all indications outside the United States. As part of the new collaboration with Baxter, CTI is pursuing a broad approach to advancing pacritinib for patients with myelofibrosis by conducting two Phase 3 clinical trials: one in a broad set of patients without limitations on blood platelet counts, the PERSIST-1 trial; and the other will be in patients with low platelet counts, the PERSIST-2 trial, which is expected to begin in early 2014. In October 2013, CTI reached agreement with the FDA on a Special Protocol Assessment, for the PERSIST-2 pivotal trial.

Is general: Yes