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Poniard Completes Patient Enrollment Target in Phase 3 SPEAR Trial of Picoplatin in Small Cell Lung Cancer
Date:3/25/2009

, chief medical officer of Poniard. "The data from this trial is event-driven and we expect that the overall survival data from the SPEAR trial will show a significant survival advantage compared to patients who receive best supportive care alone. We believe this is the first important step to provide a new treatment option for the many SCLC patients who do not achieve clinical benefit from current first-line therapies. This would be a significant accomplishment for this aggressive tumor type that has very few FDA-approved drugs."

SPEAR Trial Design

The international, multi-center, randomized, controlled, pivotal Phase 3 SPEAR trial compares picoplatin plus best supportive care, to best supportive care alone, to evaluate the efficacy and safety of picoplatin after relapse. Best supportive care includes care and treatment to optimize the comfort of patients and their ability to function, as well as to minimize the side effects of palliative cancer treatments. The primary efficacy endpoint is overall survival. Overall response rates, progression-free survival and disease control are also being evaluated.

The SPEAR trial is being conducted under the review of an independent Data Monitoring Committee, which assesses use of best supportive care to ensure balance in both arms of the trial, as well as the use of picoplatin and its safety in the treatment arm. The trial is also being conducted under a Special Protocol Assessment (SPA) developed with the FDA.

Poniard has received Orphan Drug and Fast Track designations for picoplatin for the second-line treatment of refractory or resistant SCLC from the FDA, and Orphan Drug designation from the European Commission for medicinal product status for SCLC.

About Picoplatin

Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date indicate that it has an improved saf
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SOURCE Poniard Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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