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OPTIC- first patient treated in Ariad's Phase 2 dose ranging study of iclusig for CML

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The first patient has been dosed in a Phase 2 clinical trial, called OPTIC, evaluating three doses of ARIAD Pharmaceuticals' Iclusig (ponatinib) in patients with refractory, chronic-phase chronic myeloid leukemia (CP-CML). About 450 subjects will be randomized to receive once-daily administration of 45 mg, 30 mg or 15 mg of ponatinib. Patients in the 45 mg and 30 mg cohorts will have their daily dose reduced to 15 mg upon achievement of major cytogenetic response (MCyR*). *MCyR means that 35% or less (but not 0%) of the cells in the bone marrow test positive for the Philadelphia chromosome, an abnormality of chromosome 22 that is associated with CML. The primary endpoint is MCyR by 12 months. Secondary endpoints include the rate of vascular occlusive events, rates of adverse and serious adverse events, disease control rate, progression-free survival and overall survival. Preliminary data are expected by late 2016. The estimated study completion date is December 2018. http://seekingalpha.com/news/2712856-first-patient-treated-in-ariad-phar... https://clinicaltrials.gov/ct2/show/record/NCT02467270?term=PONATINIB&ra...