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S*BIO Novel Oral JAK2 Inhibitor SB1518 Demonstrates Safety and Tolerability in Phase 1 Studies for the Treatment of Myeloproliferative and Other Hematological Disorders
Date:12/2/2009

of pharmacodynamic (PD) biomarker assays for SB1518 will be presented in a poster, demonstrating PD target efficacy of SB1518 in animal tumor models, as well as, in patients in ongoing Phase 1 clinical studies for advanced leukemias, myeloproliferative diseases and lymphoma. The fourth poster will highlight the effects of SB1518 on ex vivo expanded polycythemia vera (PV) erythroid progenitors which correlate with clinical observations.

Poster No.: 3905, Time: 6-8 p.m. CST, Monday, Dec. 7, 2009, Location: Hall E (Ernest N. Morial Convention Center)

Phase I Dose-Escalation Trial of SB1518, a Novel JAK2/FLT3 Inhibitor, in Acute and Chronic Myeloid Diseases, Including Primary or Post-Essential Thrombocythemia/ Polycythemia Vera Myelofibrosis

SB1518, which is a potent ATP-competitive inhibitor of JAK2 (IC50=22nM), JAK2V617F mutant (IC50=19nM), FLT3 (IC50=22nM) and its mutant D835Y (IC50=6nM), is being tested to determine its safety, tolerability and PK/PD profile when administered orally once daily continuously in 28-day cycles. SB1518 was well tolerated at doses up to 500 mg daily in patients with advanced myelofibrosis (MF) and acute myelogenous leukemias (AML), and shows clinical activity in MF patients with splenomegaly.

Oral Presentation Abstract No.: 588, Time: 4 p.m. CST, Monday, Dec. 7, 2009, Location: Room R02-R05

Phase 1 Study of the Novel Oral JAK2 Inhibitor SB1518 in Patients With Relapsed Lymphoma: Evidence of Clinical and Biologic Activity

A Phase 1 dose escalating study of the novel JAK2 small molecule inhibitor SB1518 is being conducted in patients with relapsed Hodgkin (HL) and non-Hodgkin lymphomas (NHL). The primary objectives are to examine the safety and efficacy of SB1518 in this patient population. Patients are treated at four dose levels (100 mg, 200 mg, 300 mg, and 400 mg) orally daily without interruption.
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