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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

Treatment was well tolerated. Three patients at the 300mg dose level demonstrated disease response with reductions in the tumor measurements (follicular lymphoma, small lymphocytic lymphoma and mantle cell lymphoma). Overall 11 patients (73%) had stable disease. Preliminary analysis demonstrated that SB1518 inhibited the JAK/STAT pathway as early as four hours after dosing. Collectively, these data demonstrate the safety of chronic administration of the oral JAK2 inhibitor SB1518. Ongoing clinical responses observed in a variety of lymphoma subtypes suggest that targeting the JAK2 pathway may have therapeutic value in patients with relapsed lymphoma.

Poster No.: 1888, Time: 5:30-7:30 p.m. CST, Saturday, Dec. 5, 2009, Location: Hall E (Ernest N. Morial Convention Center)

Pharmacodynamic (PD) Biomarker Assay Validation for SB1518, a Novel Oral JAK2 Inhibitor in Phase 1 Clinical Trials for Advanced Leukemias, Myeloproliferative Diseases and Lymphoma

Biochemical biomarker assays have been developed to assess the pharmacodynamic (PD) efficacy of SB1518 in the Phase 1 clinical trials. Initial data obtained from analysis of whole blood and PBMCs from patients treated with SB1518 in the ongoing Phase 1 clinical trials demonstrate target inhibition even at the lowest dose level of 100 mg/day on the first day of oral dosing.

Poster No. 2913, Time: 6-8 p.m. CST, Sunday, Dec. 6, 2009, Location: Hall E (Ernest N. Morial Convention Center)

The Effects of SB1518, a Novel Oral JAK2 Inhibitor, on Ex Vivo Expanded Polycythemia Vera (PV) Erythroid Progenitors (EPs) Correlate with Clinical Observations

EPs from PV patients and healthy volunteers were treated with SB1518 and other JAK2 inhibitors to determine the effects of JAK2 inhibition on downstream signalling, cell viability and JAK2V617F allele frequency. SB1518 inhibited phospho
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