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Eisai Will Initiate First Head-to-Head Study Comparing Dacogen(R) (decitabine for injection) and Vidaza(R) (azacitidine) in Patients with Myelodysplastic Syndromes
Date:12/2/2008

Randomized Comparator Study to Evaluate Efficacy of Commercially Available Hypomethylating Agents

WOODCLIFF LAKE, N.J., Dec. 2 /PRNewswire/ -- Eisai Corporation of North America today announced that it plans to initiate the first clinical trial evaluating the activity of Dacogen(R) (decitabine for injection) compared to Vidaza(R) (azacitidine) in adult patients with intermediate-1, intermediate-2 or high-risk myelodysplastic syndromes (MDS), a potentially life-threatening group of bone marrow diseases that limit the production of functional blood cells. The head-to-head trial will be conducted in the United States and will directly compare Dacogen(R) to Vidaza(R) with a primary endpoint of complete response rate (including marrow complete response).

"Previous to the introduction of the hypomethylating agents, supportive care was the only treatment option for patients living with MDS," said Dr. Hagop M. Kantarjian, chairman of the Leukemia Department and professor of medicine, University of Texas M.D. Anderson Cancer Center. "This study, for the first time, will provide physicians with important information to understand how these two agents compare when treating patients with MDS, who currently have a generally poor prognosis, with life expectancies shorter than those with lung cancer."

Study Design

This randomized, multi-center, open-label study will be conducted among 228 adult patients with intermediate-1, intermediate-2 and high-risk MDS. Patients will be randomized on a 1:1 ratio to either Dacogen(R) or Vidaza(R). Each treatment arm will be stratified by IPSS risk group and type of MDS (primary vs. secondary).

The study's primary objective is to compare the complete response rates, including bone marrow response rates, for Dacogen(R) versus Vidaza(R).

"Findings from this trial could help clarify the fundament
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SOURCE Eisai Inc.
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