SAVIENT COMPLETES PATIENT DOSING IN PHASE II CLINICAL TRIAL OF PURICASE FOR SEVERE GOUT

Savient Pharmaceuticals has completed patient dosing in a Phase II clinical trial of Puricase, a poly(ethylene glycol) (PEG) conjugate of recombinant porcine uricase (urate oxidase), for the treatment of severe, refractory gout.

The Phase II clinical study, an open-label, randomized, multicenter dose-ranging trial involving 41 patients, appears to have reproduced the dramatic, rapid and sustained reduction in plasma uric acid that was seen in the Phase I intravenous study.

Preliminary data suggest that intravenous administration of Puricase every two weeks or every four weeks rapidly achieves and maintains a level of plasma uric acid within the normal range in the majority of patients. The safety profile emerging from the open-label Phase II study appears to be acceptable for proceeding to more extensive patient exposure in a Phase III development program. This study compared three dosage levels and two dosage regimens over a twelve-week period.