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Sanofi Reports Positive Topline Results from Pivotal Phase III JAKARTA Study for JAK2 Inhibitor in Myelofibrosis
Date:5/17/2013

span> study evaluated once-daily oral SAR302503 versus placebo in 289 patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. Eligible patients with platelet counts >/=50,000/µl were randomized to receive a once-daily oral dose of either 400mg of SAR302503, 500 mg of SAR302503 or placebo for twenty-four weeks (six cycles).

The primary endpoint was the proportion of patients with a reduction in spleen volume >/=35% after 24 weeks of treatment. Key secondary endpoints include the assessment of associated symptoms as measured by total symptom score using six key symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MF-SAF) diary. Sanofi is also studying the effect of the compound on reversing fibrosis in the bone marrow. After the completion of 24 weeks of treatment or disease progression, crossover from the placebo arm to SAR302503 was allowed.

The JAKARTA study was granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration, signifying that the Phase III trial design, including clinical endpoints, is acceptable to support an application for the granting of marketing authorization in the U.S. More information about the trial is available at www.clinicaltrials.gov

About JAK2 Inhibition and SAR302503The normal functioning of the JAK/STAT pathway is key to blood cell development.  Dysregulated JAK/STAT signaling is associated with the development of MF and other related myeloproliferative neoplasms (MPN), such as Polycythemia Vera (PV) and Essential Thrombocythemia (ET).  Dysregulation of the JAK/STAT pathway in these diseases occurs with mutations of the JAK2 and MPL genes (notably JAK2V617F and MPLW515L).  In addition, up to 50% of patients with MF are considered wild-type, meaning there is no det
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