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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

hose with thrombocytopenia.16th Congress of EHAPoster No. 907 (5:30-6:45 p.m. BST, Saturday, June 11)Long-Term Safety and Efficacy Analysis of the Two Phase 1 Studies of SB1518, a Novel Oral JAK2 Inhibitor, in Patents With Advanced Myeloid Malignancies

SB1518 shows promising efficacy in MF patients with splenomegaly. Once-daily dosing is well tolerated to 29 months, with manageable GI toxicity as the main AE. SB1518 does not appear to cause myelosuppression; patients with significantly impaired hematopoiesis can receive full-dose daily SB1518 without exacerbating hematocytopenias. Sixty-three patients were consented and enrolled; 39 (62%) were men, and median age was 65.5 years. Fifty-six had MF, and 7 had AML. Median time on study is 13.3 months (1-29+). As of January 2011, 21 MF patients remain on study. The most common treatment-related AEs were gastrointestinal, which were generally low grade and manageable. These events occurred after 5.7-18.5 months on study. Two patients were discontinued for these AE's and one continues on study at 200 mg dose. Fifteen patients had dose reductions, most within the first 6 months; of these, 11 (73%) started treatment at >500 mg/d. No patients discontinued study medication because of a dose-limiting toxicity. No long-term toxicities were identified. Forty-one MF patients had palpable baseline splenomegaly >5 cm and were evaluable for spleen response. Overall, 39 (70%) of the 56 MF patients experienced CI or stable disease. Among all enrolled patients, duration of progression-free survival (PFS) ranged from 1 to 875 days (median, 563 days), with an estimated 67% rate of PFS at 12 months (Kaplan-Meier).Presentation No. 1022 (8:30-8:45 a.m. BST, Sunday, June 12)Phase 2 Study of SB1518, a Novel Oral JAK2 Inhibitor, in Patients with Primary, Post-Polycythemia Vera, and Post-Essential Thrombocythemia Myelofibrosis

SB1518 showed promising
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