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Poniard Pharmaceuticals Presents Final Results of Phase 1 Study of Oral Picoplatin Demonstrating Bioavailability
Date:4/21/2009

sion (abstract #3594) during the American Association for Cancer Research's 100th Annual Meeting 2009 at the Colorado Convention Center in Denver.

Phase 1 Study Design and Results

Poniard's randomized, open-label, dose-ranging Phase 1 study was conducted at clinical sites in the United States. The trial compared the bioavailability, pharmacokinetics, pharmacodynamics and safety of picoplatin administered orally with picoplatin administered intravenously to patients with advanced solid tumor malignancies. Bioavailability refers to the fraction of an administered dose of an unchanged drug that reaches systemic circulation. In the first part of this two-part trial, patients with advanced solid tumor malignancies were randomized to a single dose of either intravenous (120 mg/m squared) or oral picoplatin (200 mg, 300 mg or 400 mg). Four weeks later, they received a second single picoplatin dose administered via the other route. In the second part of the trial, patients received only a single oral dose of picoplatin (including doses of 50 mg and 100 mg).

Final results showed that oral picoplatin achieved oral bioavailability of nearly 100 percent at doses of 50 mg and 100 mg. No meaningful differences in pharmacokinetics were observed between the two formulations. All doses of the oral dose were well tolerated. No serious adverse events related to treatment were noted following administration of the oral dose.

About Picoplatin

Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date suggest that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have received picoplatin. Results obtained to date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other pl
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SOURCE Poniard Pharmaceuticals, Inc.
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