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Pharmion's Oral Azacitidine Granted Fast Track Status for Myelodysplastic Syndromes
Date:8/29/2007

nt should be expedited. The opportunity to explore the biological and clinical consequences of continuous oral dosing of Azacitidine is particularly exciting, since we know that DNA remethylation occurs between cycles of intermittent parenteral therapy. Effects of continuous Azacitidine dosing on tumor RNA, another potential azacitidine target, will also be explored for the first time."

Pharmion currently markets the parenteral formulation of azacitidine, known as Vidaza(R) (azacitidine for injection) for the treatment of patients with Myelodysplastic Syndromes (MDS). In January 2007 the FDA approved a new drug application supplement to add intravenous use as a new route of administration to instructions in the prescribing information for Vidaza. Earlier this month, Pharmion announced topline results from the largest study ever conducted in higher-risk MDS, which demonstrated a significant improvement in survival for patients treated with Vidaza. In the primary endpoint analysis, Vidaza treatment was associated with a median survival of 24.4 months versus 15 months for those receiving conventional care regimens, an improvement of 9.4 months (p<0.0001).

Pharmion is exploring oral Azacitidine's utility in the treatment of MDS and other cancers where demethylation may provide an anti-tumor effect. Oral Azacitidine is the subject of a Phase 1 multi-center, open label dose escalation trial that will assess the maximum tolerated dose, dose limiting toxicities and safety of a seven day, multi-cycle oral dosing regimen of oral Azacitidine in patients with MDS and AML. In addition, the trial will examine pharmacokinetics and pharmacodynamic effects of orally administered Azacitidine, as compared with parenteral Vidaza.

An oral dosage formulation of Azacitidine, in addition to the more desirable and convenient route of administration, would enable the evaluation of a low-dose regimen that could maximize demethylation and gene re-expression, as well as the ev
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SOURCE Pharmion Corporation
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