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Poniard Announces Positive First-Line Efficacy and Safety Data From Ongoing Phase 2 Trial of Picoplatin in Patients with Metastatic Hormone Refractory Prostate Cancer
Date:5/31/2008

y prednisone (5 mg) as a first-line treatment is being evaluated in 30 patients with metastatic HRPC. PSA response (defined as a PSA reduction of at least 50 percent from baseline) is the primary endpoint; secondary endpoints include safety, response rate, time to progression and overall survival. The trial completed enrollment in December 2007.

Results to date have shown a PSA response in 18 of 26 (69 percent) evaluable patients. Furthermore, PSA levels have normalized in six patients (21 percent). The combination of picoplatin and docetaxel can be safely administered with manageable and reversible neutropenia as the main hematologic toxicity. These data confirm earlier results observed in the Phase 1 trial. In contrast to picoplatin monotherapy, thrombocytopenia was less severe and less frequent. Neurotoxicity has not been observed in this study.

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.

In addition to the ongoing Phase 2 clinical trial in HRPC, 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 Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. Picoplatin is also being evaluated in an ongoing Phase 2 clinical trial in patients with metastatic colorectal cancer. Oral
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SOURCE Poniard Pharmaceuticals, Inc.
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