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Array Announces Global Phase 3 Trial Evaluating MEK162 In Patients With Low-Grade Serous Ovarian Cancer
Date:5/6/2013

BOULDER, Colo., May 6, 2013 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) today announced that it will initiate a global Phase 3 clinical trial 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 with the U.S. 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 a recent announcement by Novartis detailing plans to initiate Phase 3 trials of MEK162 in both NRAS- and BRAF-mutant melanoma and will be covered as part of the Novartis/Array co-development agreement under which costs are capped annually and in total for Array.  

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"We have seen encouraging early clinical results using a MEK inhibitor in patients with recurrent low-grade serous cancer when compared to the historic data of cytotoxic chemotherapy, the current standard of care," said Bradley J. Monk , MD, Director of the Division of Gynecologic Oncology at the University of Arizona Cancer Center at St. Joseph's Hospital in Phoenix and at the Creighton University School of Medicine. "There remains a significant unmet medical need for effective treatment in low-grade serous ovarian cancer and I look forward to investigating MEK162 in this Phase 3 study."

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