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S*BIO's Novel JAK2 Inhibitor Pacritinib (SB1518) Effectively Reduces Splenomegaly in Myelofibrosis (MF) Patients With Minimal Impact on Existing Cytopenias Providing Important Therapeutic Niche In Treatment of MF
Date:12/12/2011

SINGAPORE, Dec. 12, 2011 /PRNewswire/ -- S*BIO Pte Ltd today announced that results from a Phase 2 study demonstrated that its JAK2 inhibitor pacritinib (SB1518) effectively reduced splenomegaly in myelofibrosis (MF) patients, with minimal impact on existing cytopenias providing an important therapeutic niche in the treatment of MF. Results were presented at the 53rd ASH Annual Meeting and Exposition in San Diego.

"Pacritinib is an active drug for the treatment of splenomegaly in patients with primary myelofibrosis, post-polycythemia vera-myelofibrosis and post-essential thrombocythemia-myelofibrosis regardless of baseline thrombocytopenia," said Rami S. Komrokji, M.D., principal author of the oral presentation. "The once daily dose of pacritinib was well tolerated with manageable gastrointestinal toxicity as the main side effect. The minimal impact on existing cytopenias in MF patients provides an important therapeutic outcome for pacritinib in the treatment of this patient population. The results support the rapid advancement of pacritinib into Phase 3 clinical trials to further support its safety and efficacy."

The primary endpoint of pacritinib's Phase 2 study was to assess the spleen response rate, defined as a >/=35% reduction in MRI-measured spleen volume between baseline and week 24. Thirty-four MF patients were enrolled in the study. The most common treatment-related adverse events were gastrointestinal, which were generally low grade and easily managed.  Pacritinib was equally well tolerated by patients with normal platelet counts and those with thrombocytopenia and anemia. Thirty patients (88%) showed reduction in palpable splenomegaly, 14 (41%) showed decreases of >/=50% and five (15%) achieved clinical resolution of splenomegaly. Eight patients (24%) had decreases in spleen volume by >/=35%.  Spleen response rates were equivalent among patients with low baseline platelet counts and those with normal baseline cou
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