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Provider: Pechala's Reports
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Phase II Trial of Sanofi SA's JAK2 Inhibitor in Myelofibrosis Met Primary Endpoint

Sunday, 9 Dec 2012 09:00am EST 

Sanofi SA announced new Phase II data showing that treatment with an investigational, selective JAK2 inhibitor (SAR302503) reduced spleen size and improved constitutional symptoms in patients with intermediate-2 or high-risk primary or secondary myelofibrosis (MF), a hematologic malignancy with unmet medical needs. Results from this Phase II trial support the two doses (400 mg and 500 mg) selected for the SAR302503 Phase III JAKARTA trial that is currently under way. JAKARTA enrolled 289 patients over nine months and initial results are expected in the second quarter of 2013. The Phase II, open label, randomized dose-ranging study evaluates the efficacy of once-daily oral doses of 300 mg, 400 mg, and 500 mg of SAR302503 for the reduction of spleen volume. The primary endpoint is change in spleen volume at the end of cycle three assessed by MRI with independent central review. Secondary endpoints include spleen response (reduction in spleen volume greater than or equal to 35% vs. baseline), safety and symptom response using the MPN-SAF scale. 

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