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YM BioSciences Reports Positive Interim Data Including Substantial Anemia Response from Phase I/II Trial of JAK1/JaK2 Inhibitor CYT387
Date:12/6/2010

Forty-eight (80%) had palpable splenomegaly greater than 10 cm. A number of the patients had discontinued treatment with other JAK inhibitors (INCB018424, n=11; TG101348, n=3) or pomalidomide (n=13). The median time to follow up since study start is currently 4.9 months, ranging from 0.9-12.5 months.

Efficacy Results: - The Overall Response Rate (anemia, spleen) to date, as per the International Working Group for Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria, is 62%. - Anemia Response: Of 42 subjects who were evaluable for anemia response (baseline Hgb less than 10 g/dL or red cell transfusion- dependent), 21 subjects (50%) had achieved Clinical Improvement (CI) as per the IWG-MRT criteria. A 57% response rate was observed in transfusion dependent patients. For the 150 mg/day dosing group, the anemia response rate was 41% (43% for transfusion dependent patients). For the 300 mg/day dosing group, the anemia response rate was 58% (69% for transfusion dependent patients). Responses were observed in five of nine (55%) patients who had discontinued treatment with other JAK inhibitors (INCB018424, TG101348) and 5 of 12 (42%) who had discontinued pomalidomide. - Spleen Size Reduction: Twenty-five (47%) of the 53 evaluable subjects who had splenomegaly at baseline achieved a minimum 50% decrease in palpable spleen size, thus qualifying them for CI per IWG-MRT criteria. For the 150 mg/day dosing group, 53% qualified for CI. For the 300 mg/day dosing group, 46% qualified for CI. - Constitutional Symptoms: CYT387 controlled constitutional symptoms in a significant percentage of patients (night sweats: 88%, bone pain: 80%, pruritus: 92%, fever: 100%).

Safety Results:

In the dose escalation portion of the study, at the highest dose level (400 mg/day), two of six subjects experienced dose limiting toxicity (DLT) (one each of reversible asymptomatic Grade 3 hyperlipasemia and Grade 3 headache); consequently, the maximum tolerated
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SOURCE YM BioSciences Inc.
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4. YM BIOSCIENCES REPORTS SIGNIFICANT RESPONSE RATES IN ANEMIA, SPLENOMEGALY, AND CONSTITUTIONAL SYMPTOMS FROM THE PHASE I/II TRIAL OF ITS JAK1/JAK2 INHIBITOR, CYT387, IN MYELOFIBROSIS
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