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YM BioSciences Reports Positive Interim Data Including Substantial Anemia Response from Phase I/II Trial of JAK1/JaK2 Inhibitor


//health-fitness.news-articles.net/content/2010/ .. rom-phase-i-ii-trial-of-jak1-jak2-inhibitor.html
Published in Health and Fitness on Monday, December 6th 2010 at 8:20 GMT by Market Wire   Print publication without navigation


 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%). 
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