Pharmion Corporation has announced that the multi-centre, open label phase I clinical trial of single dose oral azacitidine in patients with myelodysplastic syndromes (MDS), AML and malignant solid tumours 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 phase I trial 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 FDA 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.
"We are extremely pleased that we have been able to demonstrate oral bioavailability and move into the multi-dose stage of the phase I development," said Andrew Allen, MD, MRCP, Ph.D., Pharmion's chief medical officer and executive vice president. "In particular, we are looking forward to examining the pharmacokinetic and pharmacodynamic profile of the drug as we plan for phase II and registration studies."
"The progress of oral azacitidine is extremely exciting as it allows for the possibility of sustained DNA demethylation in a convenient manner," said Dr Guillermo Garcia-Manero, chief, section of Myelodysplastic Syndromes, D Anderson Cancer Center. "There is a substantial body of evidence that sustained DNA demethylation could impact many tumour types and possibly turn certain cancers into chronically managed diseases. We are very enthusiastic about testing this hypothesis with oral azacitidine."