First Analysis Of Extended Dosing With Celgene's CC-486 Presented At ASH

(RTTNews) - Celgene International Sàrl, an unit of Celgene Corp. (CELG), said that ad hoc analysis'results of a subset of subjects with higher-risk myelodysplastic syndrome or MDS from two ongoing phase I/II trials of oral epigenetic agent CC-486 were presented at the American Society of Hematology or ASH annual meeting in New Orleans, La.

During this analysis, 23 patients with WHO-defined RAEB-1 or RAEB-2 MDS who received CC-486 300mg once per day or 200mg twice per day for 14 or 21 days of repeated 28-day cycles. For purposes of this analysis, subject data were analyzed collectively. Hematologic responses were defined by International Working Group 2006 criteria. Overall response rate or ORR was calculated as any response of complete or partial remission and/or any hematologic improvement (HI). Marrow complete remission was not included in ORR.

Sixty-one percent of the subjects had a diagnosis of RAEB-1 and 39% had RAEB-2, median time from diagnosis was 2.1 months, and ECOG performance status scores were 0, 1 or 2. The company said an overall response was met by 48% of subjects with 17% subjects achieving a complete remission, no patients achieving a partial remission and 30% of patients achieving a hematologic improvement.

The study results of patients with higher-risk MDS warrant further clinical evaluation. CC-486 is not approved for the treatment of any disease.