Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral ...( SOUTH SAN FRANCISCO Calif. Nov. 6...),Health

SOUTH SAN FRANCISCO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced top-line results from its Phase 1 clinical trial of an oral formulation of picoplatin in patients with solid tumors showing that picoplatin achieves linear and dose-dependent plasma exposure when given by the oral route. The results demonstrated that exposure to orally administered picoplatin was linear at doses below 200 mg, and that maximum exposure to orally administered picoplatin was achieved at doses of 200 mg or greater indicating sufficient bioavailability to support further clinical studies.

"Achieving sufficient bioavailability with oral picoplatin is extremely encouraging and supports further clinical development of an oral formulation of the drug, as it may provide a more convenient, flexible dosing routine for patients who would benefit from picoplatin," said Robert De Jager, M.D., chief medical officer of Poniard. "Orally administered picoplatin may be desirable for cancer patients receiving radiation therapy and in combination with other oral therapies."

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 in 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
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