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Array BioPharma Reports Financial Results for the Third Quarter of Fiscal 2013
Date:5/6/2013

ussion of endpoints other than overall survival that could be used as the basis for approval.  The FDA also agreed that Low / Int-1 patients who have failed a hypomethylating agent, such as Vidaza, can be considered a high unmet medical need population.  Array now has guidance on a potential path to registration and, pending additional data from the ongoing study, plans to make decisions on future study designs by the end of 2013.

ARRY-502 – CRTh2 antagonist for asthma completed recruitment in Phase 2a trial; results expected summer 2013 Array has completed recruitment of a 182-patient Phase 2a trial with ARRY-502, a CRTh2 antagonist, in mild to moderate persistent asthma.  Array expects top-line results from this trial during the summer of 2013 and intends to seek a partner for further development of ARRY-502 in this large market disease indication, which may provide Array with additional non-dilutive financing. 

MEK162 –Phase 3 pivotal trial announced and MEK162 data to be presented at ASCO Array will initiate a global Phase 3 clinical trial with MEK162 in patients with recurrent low-grade serous ovarian cancer (LGSOC) during the summer of 2013.  The study called MILO (MEK Inhibitor in Low Grade Serous Ovarian Cancer), will evaluate the efficacy and safety of MEK162 compared to standard chemotherapy treatments and is designed for worldwide regulatory submissions, including the US Food and Drug Administration and the European Medicines Agency.  Array invented MEK162 and licensed worldwide rights to develop and commercialize the drug to Novartis in April 2010.  The MILO study follows the recent announcement by Novartis to initiate Phase 3 trials of MEK162 in both NRAS- and BRAF-mutant melanoma and will be covered under the Novartis/Array co-development agreement where the costs are capped annually and in total for Array.The following scientific poster on MEK162 will be presented by Novartis at the 20
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