BOULDER, ColoradoThe FDA has approved Pharmion Corporation's NDA supplement to add IV use as a new route of administration for the company's DNA demethylation agent Vidaza (azacitidine) for the treatment of myelodysplastic syndrome (MDS). Hypomethylation may restore normal function to genes critical for differentiation and proliferation. A parenteral formulation of the agent is currently available.
The company also received an IND for the first human trial of oral Vidaza. The phase I trial will include patients with MDS, acute myelogenous leukemia, and malignant solid tumors.