Array BioPharma announced that it will initiate a global Phase 3 clinical trial in patients with recurrent low-grade serous ovarian cancer during the summer of 2013. The study, called MILO, 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.
- Pharmaceuticals & Drug Trials
- European Medicines Agency