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Poniard Pharmaceuticals Presents Final Results of Phase 1 Study of Picoplatin in Patients with Metastatic Colorectal Cancer
Date:4/21/2009

gression-free survival data at the 2009 American Society of Clinical Oncology Annual Meeting."

The picoplatin data were presented today in a poster session (abstract #3578) during the American Association for Cancer Research's 100th Annual Meeting 2009 at the Colorado Convention Center in Denver. Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent in clinical development to treat multiple types of cancer. It is designed to overcome platinum resistance associated with chemotherapy in solid tumors.

Phase 1 CRC Study Design and Results

In the Phase 1 study, 73 patients received the FOLPI regimen with picoplatin administered either every two or every four weeks to evaluate safety and identify the maximum tolerated dose and the optimal schedule of FOLPI administration. Patients received a total picoplatin exposure of between 85 mg/m squared and 1,871 mg/m squared.

None of the patients who received picoplatin exhibited severe neuropathy (Grade 3 or 4), as is commonly seen in metastatic CRC patients treated with the FOLFOX regimen at cumulative oxaliplatin doses above 800 mg/m squared. In addition, none of the patients who received picoplatin exhibited severe (Grade 3/4) nephrotoxicity (kidney toxicity) or ototoxicity (hearing toxicity).

The dose limiting toxicities for both the every-four-week regimen and the every-two-week regimen were neutropenia and thrombocytopenia, which were reversible. The maximum tolerated dose of picoplatin in the every-four-week FOLPI schedule was 150 mg/m squared. 150 mg/m squared for the every-four-week FOLPI schedule and 85 mg/m squared for the every-two-week FOLPI schedule achieved 80 percent of the planned dose and support further clinical studies at these doses and schedules. The 150 mg/m squared dose and schedule was selected for evaluation in the ongoing randomized Phase 2 trial.

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SOURCE Poniard Pharmaceuticals, Inc.
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