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Array BioPharma Reports Financial Results For The First Quarter Of Fiscal 2014 And Announces ARRY-520 Development Strategy
Date:10/31/2013

ive results will support future regulatory submissions and also help validate the use of AAG. In addition, published results from this trial should support Phase 3 enrollment.  Array is planning to initiate the Phase 3 trial prior to completing this study. 

The second study will evaluate ARRY-520 as a single agent in a robust global Phase 2 trial in patients with RRMM including both low- and high-AAG patients.  Trial initiation is planned for mid-2014.  The primary endpoint will be ORR in patients with low levels of AAG.  This trial is also designed to support future regulatory submissions, will include important safety and pharmacology data, and will also validate the use of AAG. 

Four abstracts on ARRY-520 have been submitted for presentation at the 2013 American Society of Hematology (ASH) Annual Meeting in December 2013. These include data from the following studies:  ARRY-520 plus dexamethasone, ARRY-520 plus Kyprolis, ARRY-520 plus Velcade and preclinical data regarding ARRY-520 plus Pomalyst.  ASH is the world's largest professional society concerned with the causes and treatments of blood disorders.

ARRY-614 – Patient enrollment complete in myelodysplastic syndromes (MDS) clinical trial
ARRY-614 is being studied in Low/Intermediate-1 MDS, a population of more than 100,000 patients in developed countries.  In a previous study of ARRY-614, multi-lineage activity was observed with the most promising effects seen in patients with thrombocytopenia, with several platelet transfusion-dependent patients becoming tranfusion-independent.  Array is evaluating a new formulation of ARRY-614 in an ongoing dose-escalation clinical trial. The maximum tolerated dose has been established and expansion cohorts have been fully enrolled and are ongoing.  Pharmacokinetic and pharmacodynamics assays performed as part of the trial have demonstrated improved bioavailability and target coverage rel
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