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Feb 2
USFDA Accepted Pharmion’s IND for Oral Azacitidine (Vidaza®)

Submitted in December 2006, Pharmion Corporation (Nasdaq: PHRM) Investigational New Drug (IND) application for the Company's oral formulation of azacitidine is now active following its acceptance by the USFDA.

The parenteral formulation of azacitidine - Vidaza® (azacitidine for injection) - for the treatment of patients with Myelodysplastic Syndromes (MDS), is currently marketed by Pharmion.

vidaza_injection.jpgVidaza 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 azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.

(The USFDA has recently approved a new drug application supplement to add intravenous use as a new route of administration to instructions in the prescribing information for Vidaza®.)

According to Andrew Allen, Pharmion's chief medical officer:

"DNA demethylating agents, like the approved parenteral formulation of azacitidine, Vidaza, have been shown to be a safe and effective therapy for MDS.

There is a significant body of evidence that shows that the biological effects of these agents may be improved or extended through sustained DNA demethylation, which could most realistically be provided through oral delivery.

We are excited about testing this hypothesis in human clinical studies and reinforcing our leadership in the development of epigenetic anti-cancer therapies."

Find more details from the Pharmion press release.

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