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Additional Data From Multiple Phase 1 and 2 Studies of S*BIO's Novel JAK2 Inhibitor SB1518 Demonstrate Safety and Efficacy for Treatment of Symptomatic Myelofibrosis (MF)
Date:6/1/2011

efficacy in alleviating MF-associated splenomegaly and constitutional symptoms at a dose that induces minimal myelosuppression. Once-daily dosing was well tolerated, with manageable GI toxicity as the main side effect. Given the lack of myelosuppression, SB1518 was of particular importance for MF patients with impaired hematopoiesis. Thirty patients (88%) showed reductions in palpable splenomegaly; 15 (44%) showed decreases of >50% and seven (21%) showed a reduction of 100%. At Week 24, 23 patients (68%) showed spleen reduction (3% to 50% by MRI volumetric assessment). Nine patients (26%) had reduction in splenomegaly by >35% reduction. Splenic reduction of 50% by PE correlated with a 25% reduction in spleen volume by MRI. Twelve patients (35%) had reduction in splenomegaly by >25%. Spleen response rates were as high among patients with low baseline platelet counts as those with normal baseline counts. Responses were durable; response duration among those achieving an IWG MRT response ranged from 1 to 164+ days (median, not reached). Two patients met IWG-MRT criteria for clinical improvement in hemoglobin and 1 for platelet count. At the 6 month visit, a significant reduction (>2 point improvement) was observed for MF associated symptoms, including abdominal pain, cough, and night sweats.About S*BIO Pte LtdS*BIO is a privately-held biotech company focused on the research and clinical development of novel targeted small molecule drugs for the treatment of cancer with leading programs around kinases and histone deacetylases (HDAC). SB1518, S*BIO's potent and orally-active JAK2 inhibitor, entered the clinic in 2008 and has now completed Phase 2 trials for MF.  It has received orphan drug designation from the U.S. and the E.U. regulatory authorities. S*BIO's lead HDAC inhibitor, SB939, is currently in Phase 2 trials. S*BIO's SB1317, a novel multikinase inhibitor, is in Phase 1 tr
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