Poniard Pharmaceuticals, a US biopharmaceutical company focused on oncology, has announced treatment of the first patient in a Phase I clinical trial of oral picoplatin. The company previously announced that it had filed an Investigational New Drug application with the Food and Drug Administration for an oral formulation of picoplatin in February 2007.
The Phase I, randomized, open-label, dose-ranging study is comparing the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin given intravenously in around 18 patients with advanced solid tumor malignancies. The trial is being conducted at clinical sites in the USA and is expected to take six months to complete.
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