Pharmion's oral azacitidine advances

US firm Pharmion says that the multicenter, open label Phase I clinical trial of single dose oral azacitidine in patients with myelodysplastic syndromes, acute myeloid leukemia and malignant solid tumors has been successfully completed, and the company will be initiating the planned multi-dose Phase I trial. The first Phase I trial assessed the bioavailability and pharmacokinetics of escalating single doses of orally administered azacitidine, while exploring the preliminary safety and tolerability profile of the compound.

The second is a multi-center, open label dose escalation trial and will assess the maximum tolerated dose, dose-limiting toxicities and safety of a seven day, multi-cycle oral dosing regimen of azacitidine in patients with MDS and AML. In addition, the trial will examine pharmacokinetics and pharmacodynamic effects of orally administered azacitidine, as compared with the Food and Drug Administration-approved parenteral regimen, which is marketed by Pharmion as Vidaza (azacitidine for injection). Pharmion intends to present pharmacokinetic data from the first Phase I study in a poster session at the Annual Meeting of the American Society of Clinical Oncology in June and additional Phase I data is expected to be presented later in the year.