Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral ...(a single dose ofeither intravenous (120 ...),Health

Date:11/6/2008

a single dose of either intravenous (120 mg/m squared) or oral picoplatin (200, 300 or 400 mg). Four weeks later, they were crossed over to a second single picoplatin dose administered via the alternative route. In the second part of the trial, patients received only a single oral dose of picoplatin (including doses of 50 and 100 mg).

Results showed that oral picoplatin can achieve oral bioavailability of up to 44 percent in the doses tested in the first arm. Results also showed that picoplatin oral bioavailability is linear, and maximum exposure to orally administered picoplatin was achieved at doses of 200 mg or greater. Additionally, following four weeks of dosing with either oral or intravenous picoplatin, only background levels of circulating platinum could be detected, suggesting no drug accumulation between dosing cycles.

There were no differences in pharmacokinetics observed, and all doses were well tolerated with no serious adverse events related to treatment noted following the oral dose. No myelosuppression occurred after oral dosing.

Poniard expects to present additional data from the trial at scientific meetings during 2009.

About Picoplatin

Picoplatin has an improved safety profile relative to existing platinum- based cancer therapies and is designed to overcome platinum resistance associated with chemotherapy in solid tumors. It is being studied in multiple cancer indications, combinations and formulations. Picoplatin has been evaluated in more than 750 patients and has demonstrated anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs.

Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registration trial currently is being conducted under a Special
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SOURCE Poniard Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

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