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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

er-stage clinical studies."

SB1518 is a small molecule JAK2-selective kinase inhibitor, which has demonstrated high potency in preclinical models against both the wild type JAK2 kinase and the JAK2 kinase with the V617F mutation. The V617F mutation is found in high frequencies in myeloproliferative disorders such as MF. It is estimated that approximately 50% of patients with MF possess the JAK2 mutation.

2011 ASCO Annual MeetingPoster Board 7, Abstract No. 6515 (2-6 p.m. CDT, Friday, June 3)Poster Discussion Session (5-6 p.m. CDT, Friday, June 3)Phase 2 Study of SB1518, an Orally Available Novel JAK2 Inhibitor, in Patients with Myelofibrosis

SB1518 showed promising efficacy in symptomatic MF patients with splenomegaly. Once daily dosing was well tolerated, with manageable grade 1 and 2 GI toxicity as the main side effect. Patients with significantly impaired hematopoiesis could receive full-dose daily of SB1518 without exacerbating hematocytopenias. Thirty-three patients with MF were enrolled. Median spleen enlargement by physical examination (PE) was 18 cm below the LCM. Of 30 patients assessed by MRI, 29 had a spleen volume reduction; 17 (57%) had a reduction of > 25%. Of 31 patients assessed by PE, 12 (39%) had a reduction of >50%, and seven (23%) had a reduction of 100%. Results showed that a 50% reduction in spleen length by PE corresponded to a 25% reduction in spleen volume by MRI (p=0.043). Intensity of MF-related symptoms decreased by 40-65% in patients treated for 6 months. The most common treatment-related toxicities were diarrhea (81%; 6% Gr 3), nausea (41%; all Gr 1/2), vomiting (22%; all Gr 1/2), and fatigue (9%; all Gr 1/2). These events were readily managed. At six months, 21 patients remain on therapy. Significant neutropenia and thrombocytopenia were not seen (no Gr 3/4 events). SB1518 was tolerated equally well by patients with normal platelet counts and t
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