ARRY-614

Target: p38 / Tie2 | Indication: Myelodysplastic Syndromes (MDS)

Introduction / Brief Description

ARRY-614, a potent, small-molecule dual p38/Tie2 inhibitor, is being studied in patients with International Prognostic Scoring System (IPSS) low and intermediate-1 risk MDS.  In an initial dose-escalation study, using a powder-in-capsule formulation of ARRY-614, multi-lineage activity was observed. The most promising effects were seen in patients with thrombocytopenia and neutropenia, with transfusion independence frequently observed in platelet transfusion-dependent patients.  As presented at the American Society for Hematology (ASH) meeting in December 2013, multi-lineage responses as well as platelet transfusion independence have again been observed in this study.  Array has no plans to invest internally at this time in ARRY-614.

MDS

According to an article published in the Journal of Clinical Oncology in 2010, there were 45,000 newly diagnosed cases of MDS in the U.S. Medicare population (≥65 years) in 2003.  Currently approved therapies provide improvement of MDS-related symptoms, but many patients fail to respond to or are intolerant to therapy or progress after experiencing an initial response. As a result, there remains an unmet need for new agents in the treatment of patients with MDS.

Publications

ARRY-614 / MDS

12/08/2014

American Society of Hematology Annual Meeting

Efficacy of Dual Inhibition of p38 Mitogen Activated Protein Kinase (MAPK) and Tie-2 Kinase in Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)

L.S. Bachegowda MD MRCP, et al.

ARRY-614 / MDS

12/05/2014

Clinical Cancer Research

A Phase I Study of Oral ARRY-614, a p38 MAPK/Tie2 Dual Inhibitor, in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes

G. Garcia-Manero, et al.

ARRY-614 / MDS

12/09/2013

American Society of Hematology Annual Meeting

Phase 1 Dose-Escalation/Expansion Study of ARRY-614 in Patients with IPSS Low/Int-1 Risk Myelodysplastic Syndromes

G. Garcia-Manero, et al.

ARRY-614 / MDS

04/06/2013

American Association for Cancer Research Annual Meeting

The Design and Early Development of the P38/Tie-2 inhibitor, ARRY-614 in Hematologic Cancers

K. Koch Ph.D.

ARRY-614 / MDS

12/09/2012

American Society of Hematology Annual Meeting

Role of p38 MAPK and Tie2 in the Pathogenesis of MDS and Their Inhibition by Dual Inhibitor ARRY-614

S. L. Winski, et al.