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

ectable JAK2 or MPL mutations, yet do demonstrate dysregulated JAK2 signaling.

SAR302503 is a novel, investigational, JAK2 kinase inhibitor that selectively inhibits the JAK2 kinase, and in preclinical studies it has demonstrated activity against MF cells containing either JAK2V617F or MPLW515L mutation. As demonstrated in earlier Phase I and II studies, SAR302503 demonstrated activity in MF patients with both wild-type and mutated JAK2 (JAK2V617F). Another Phase II study in ruxolitinib-exposed patients who are either resistant or intolerant to ruxolitinib is ongoing.

About MyelofibrosisMyelofibrosis (MF) is a rare, but serious blood disease characterized by abnormal blood cell production and fibrosis (scarring) within the bone marrow. Scarring in the bone marrow interferes with blood cell production, and the spleen and liver compensate by producing and storing extra blood cells, which cause an enlarged spleen. Of the mutated JAK2‐associated myeloproliferative neoplasms, MF carries the poorest prognosis. Median survival for intermediate-2 and high-risk patients is approximately two and a half years; median survival for MF patients overall is approximately six years, and the 10 year risk of the disease transforming to fatal acute myelogenous leukemia (AML) is about 20%.[i]

The exact prevalence of MF is not known.  The latest research estimates that the prevalence of MF ranges from 4.2 to 5.6 per 100,000 people in the U.S., or approximately 15,000 patients.  Prevalence estimates in Europe are less clear.  People over age sixty are most likely to develop this disease, with men and women equally at risk.

About Sanofi Oncology Sanofi Oncology is a global division of Sanofi based in Cambridge, Massachusetts and Vitry, France.  At Sanofi Oncology, the patient is our inspiration. We are dedicated to translating science into effective therapeutics that address unmet med
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