Clinical Data From Initial REVLIMID(TM) Study in

Press Release:

Clinical Data From Initial REVLIMID(TM) Study in Myelodysplastic Syndromes Reported

Press Release
News Article February 2005

* 63% of Transfusion Dependent Patients, On An Intent-To-Treat-Basis, Achieved Transfusion Independence

* At 81 Weeks, Median Duration of Transfusion Independence Had Not Been Reached

* 75% of Patients On An Intent-To-Treat Basis with 5q Deletion Chromosomal Abnormality Achieved Major Response of Whom 83% Became Transfusion Independent

SUMMIT, N.J., Feb. 9 /PRNewswire-FirstCall/ -- The New England Journal of Medicine today published results of a Celgene Corporation sponsored Phase I/II trial evaluating REVLIMID(TM) (lenalidomide) therapy for myelodysplastic syndromes (MDS). This study was conducted at the Sid Salmon Cancer Center, at the University of Arizona, by Alan List, M.D., currently Professor of Medicine and Program Leader Hematologic Malignancies at H. Lee Moffitt Cancer Center, Tampa, Florida. MDS is a malignant disorder of blood cell production that affects approximately 300,000 people worldwide. The most common clinical manifestation associated with MDS is refractory anemia, and the multiple complications that stem from frequent blood transfusions. Celgene's lead IMiD(R) (Immunomodulatory drug), REVLIMID has received both orphan drug status and fast track designation from the U.S. Food and Drug Administration (FDA) and orphan drug status from the European Agency for the Evaluation of Medicinal Products for the treatment of MDS.

Ten of 12 patients with the 5q deletion achieved transfusion independence accompanied by complete cytogenetic response (disappearance) of chromosomal abnormalities.

"Results of this study led to the development of two larger multi-center open-label trials of transfusion dependent patients with and without 5q deletions. Preliminary data from these two larger studies are consistent with the results of this publication in the New England Journal of Medicine," said Alan List, M.D., the study's lead investigator.

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