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Celgene Corp's Celgene International Sàrl announces first analysis of extended dosing with Celgene Epigenetic Agent CC-486 in patients with higher-risk Myelodysplastic Syndromes


Saturday, 7 Dec 2013 09:37pm EST 

Celgene Corp:Says that Celgene International Sàrl, a wholly owned subsidiary of Celgene Corp announced that results from an ad hoc analysis of a subset of subjects with higher-risk myelodysplastic syndrome (MDS) from two ongoing phase I/II studies of oral epigenetic agent CC-486 (oral azacitidine).Says that in this analysis, 23 patients with WHO-defined RAEB-1 or RAEB-2 MDS who received CC-486 300mg once per day (n=20) or 200mg twice per day (n=3) for 14 or 21 days of repeated 28-day cycles.Says that for purposes of this analysis, subject data were analyzed collectively.Says that Hematologic responses were defined by International Working Group (IWG) 2006 criteria.Says that overall response rate (ORR) was calculated as any response of complete or partial remission (CR or PR) and/or any hematologic improvement (HI).Says that marrow complete remission (mCR) was not included in ORR.Says that 14 subjects (61 pct ) had a diagnosis of RAEB-1 and 9 (39 pct) had RAEB-2, median time from diagnosis was 2.1 (0.1 - 33.2) months, and ECOG performance status scores were 0 (n=4, 17 pct), 1 (n=15, 65 pct), or 2 (n=4, 17 pct).Says that overall response was achieved by 11/23 subjects (48 pct) with 4/23 (17 pct) subjects achieving a complete remission, no patients achieving a partial remission and 7/23 patients (30 pct) achieving a hematologic improvement. 

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