Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndr...(were randomized on a 1:1 ratio toeither ...),Health

Date:8/19/2007

were randomized on a 1:1 ratio to either Vidaza of the CCR with stratification by FAB subtypes (RAEB or RAEB-T) and IPSS subgroups (INT-2 or HIGH). Investigators selected the CCR option for each individual patient prior to randomization. The primary objective of the trial was to demonstrate superiority in survival of Vidaza plus best supportive care versus CCR plus best supportive care in higher-risk MDS patients. Secondary objectives of the trial included transfusion independence, hematologic status, hematologic response and hematologic improvement, episodes of infections requiring intravenous antibiotics, time to relapse after complete response (CR) or partial response (PR), time to disease progression, time to transformation to AML, time to transformation or death from any cause, safety and toxicity and pharmacoeconomics.

About Vidaza

In May 2004, Vidaza became the first drug approved by the FDA for the treatment of patients with Myelodysplastic Syndromes (MDS). The FDA approved Vidaza, the first in a new class of drugs called demethylation agents, for treatment of all five MDS subtypes, which include both low-risk and high-risk patients. These subtypes include: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

Vidaza is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of Vidaza required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of Vidaza cause the death of rapidly dividing cells,
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SOURCE Pharmion Corporation Copyright©2007 PR Newswire.

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