The first trial was designed to asses the safety and tolerability of oral azacitidine in patients with myelodysplastic syndromes (MDS)and AML, while the second study will asses pharmacokinetics and pharmacodynamic effects of the drug compared to Pharmion’s Vidaza, which is an injectable form of azacitidine.
In May 2004, Vidaza became the first drug approved by the FDA for the treatment of patients with MDS.