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Dacogen(R) (decitabine for injection) Data Presented on a Phase II Clinical Trial in Elderly Patients with Acute Myeloid Leukemia (AML)
Date:12/8/2008

Response Observed Across All Subtypes of AML, Including Those with Poorest Prognoses

SAN FRANCISCO, Dec. 8 /PRNewswire/ -- Eisai Corporation of North America today announced data from a Phase II trial evaluating a five-day dosing regimen of Dacogen(R) (decitabine for injection) in acute myeloid leukemia (AML), the most common form of leukemia. The study involved elderly patients with AML, who often have limited options due to comorbidities and are typically considered ineligible for standard induction chemotherapy. These data were presented today at the American Society of Hematology (ASH) 50th Annual Meeting.

Dacogen(R) is indicated for treatment of patients with myelodysplastic syndromes (MDS), including those with refractory anemia with excess blasts (immature or unformed blood cells) in transformation (RAEB-T - now re-classified by World Health Organization [WHO] as AML). Phase II and III clinical trials evaluating Dacogen(R) in patients with AML are currently underway.

Data from the Phase II study reported a complete response rate of 24 percent. A complete response designation requires that the patient have less than 5 percent blasts in the marrow, no evidence of disease outside of the bone marrow and absolute neutrophil and platelet counts of more than 1,000/uL and 100,000/uL, respectively. The majority of patients in the trial had intermediate or poor risk cytogenetics (bone marrow tests to identify abnormal chromosomes), which are associated with poor prognoses. Responses were observed across all patients including those with poor risk cytogenetics, those whose AML transformed from MDS, or those who developed AML after previous treatment for cancer. The results presented at ASH provide additional support for the ongoing investigation of Dacogen(R) in a Phase III trial currently underway in elderly patients with AML.

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SOURCE Eisai Inc.
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