Array BioPharma Issues Update on ARRY-614 for Myelodysplastic Syndromes at '13 ASHM

Earlier today, Array BioPharma Inc.

announced updated clinical safety and efficacy data on ARRY‑614 in patients with myelodysplastic syndromes (MDS) at the 2013 Annual Meeting of the American Society of Hematology. (Logo: http://photos.prnewswire.com/prnh/20121029/LA02195LOGO) ARRY-614 is a potent inhibitor of p38/Tie2 with a mechanism of action distinct from drugs currently available to treat MDS.  It is being studied in an ongoing dose-escalation trial in IPSS low/intermediate-1 risk MDS patients, representing a population of more than 100,000 patients in developed countries.  The dose-escalation portion of the trial established the maximum tolerated dose, and subsequent expansion cohorts have been fully enrolled. Of patients currently evaluable for efficacy, 21% achieved a Hematologic Improvement, as defined by International Working Group 2006 (IWG). Of particular interest, 44% of platelet-transfusion dependent patients achieved Transfusion Reduction, and 31% achieved Transfusion Independence. Lower risk MDS patients with severe low platelet counts have a particularly poor prognosis. The most common treatment-related adverse events across all doses were rash (39%), nausea (17%), and atrial fibrillation (13%).  The majority of these events were mild or moderate in severity. "The emerging results from this study with ARRY-614 are very promising," said Guillermo Garcia-Manero, M.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.  "ARRY-614 was generally well tolerated in these lower-risk MDS patients and I am particularly encouraged with the platelet effects observed in patients with thrombocytopenia, including platelet transfusion independence.  Responses were seen in patients for whom hypomethylating agents had failed, a group with no available treatment options." "Significant unmet needs remain in the treatment of MDS," said Michael Needle, M.D., Chief Medical Officer, Array BioPharma.  "ARRY-614 is thought to operate at the progenitor cell level, distinct from currently available therapies, offering a unique mechanism of action for treatment of the cytopenias associated with MDS." A PDF of the slides are available on Array's website at www.arraybiopharma.com.