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Celgene Presents Revlimid Study in Myelodysplastic

June 7, 2005

Celgene has presented Revlimid clinical data from a multicenter Phase II trial evaluating Revlimid in patients with low and intermediate-1 risk myelodysplastic syndromes.

The analysis was based on clinical data available as of March 31. This trial will continue and be updated on an ongoing basis. Researchers reported that 215 patients entered the study, of whom, 166 were documented to have low to intermediate-1 risk MDS. Of the patients who entered the study, the median age was 72 years (range, 27-94). Forty-six patients remain on study.

On a per-protocol analysis (eligible basis), 84 patients (51 percent) responded to treatment. Fifty-four patients (33 percent) became transfusion independent as defined by a more stringent modification of the MDS International Working Group (IWG) Response Criteria, requiring eight consecutive weeks without a blood transfusion and a 1g/dL or greater rise in hemoglobin. Thirty patients (18 percent) achieved a minor response, defined as a 50 percent or greater decrease in blood transfusion requirement. The median duration of transfusion-independence was 41 weeks.