Sanofi announces new data from SAR302503 Phase II trial on myelofibrosis

Published on December 10, 2012 at 1:23 AM · No Comments

Sanofi (EURONEXT: SAN and NYSE: SNY) announced today new Phase II data showing that treatment with a novel, 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. The data were presented today during the 2012 Annual Meeting of the American Society of Hematology in Atlanta, Ga., December 8-11, 2012.

"The results observed in our trial with SAR302503 are encouraging," said Moshe Talpaz, M.D., Professor, Department of Internal Medicine, University of Michigan and lead investigator of the study.  "New treatment options are needed to fulfill existing treatment gaps for patients with these debilitating blood disorders, and specifically targeting the JAK2 enzyme appears to offer a promising approach."

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.

"I am very pleased with how much progress has been made in the development of our JAK2 inhibitor. This study confirms the once-daily oral administration of SAR302503 identified for use in the Phase III trial in this difficult-to-treat patient population," said Debasish Roychowdhury, M.D., Senior Vice President and Head, Sanofi Oncology"We believe SAR302503 could provide a benefit to these patients with primary and secondary myelofibrosis and we look forward to our Phase III results next year."  

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 percent vs. baseline), safety and symptom response using the MPN-SAF scale.

According to the study results, treatment was associated with reductions in spleen size and other disease symptoms in 31 randomized patients.

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