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Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Evaluating Picoplatin in Small Cell Lung Cancer Reaches 320th Event Target
Date:9/15/2009

SOUTH SAN FRANCISCO, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) today announced that 320 evaluable events (patient deaths) have occurred in its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial, which is being conducted in accordance with a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), evaluating picoplatin in the treatment of small cell lung cancer (SCLC).

"The 320th event in our pivotal registration SPEAR trial was defined in our SPA with the FDA to enable the Company to begin final analysis of data. Our goal is to complete and report the results of our preliminary analysis in the fourth quarter of 2009 and, if positive, initiate the rolling New Drug Application filing process for picoplatin by year-end under the Fast Track designation previously granted by the FDA," said Jerry McMahon, Ph.D., chairman and CEO of Poniard. "The SPA helps ensure that the design and clinical endpoints of our randomized trial and our planned analysis of the study are aligned with the FDA to support submission of an NDA."

SPEAR Trial Design

The international, multi-center, randomized, controlled Phase 3 SPEAR trial is evaluating the efficacy and safety of picoplatin as second-line therapy in 401 cancer patients with SCLC who have not responded to or who relapsed following first-line platinum-based therapy. The primary endpoint of the trial is overall survival. The Statistical Analysis Plan of the trial, as agreed to in the SPA, is 90 percent powered to show a 33 percent reduction in risk in overall survival for picoplatin treatment with best supportive care (BSC) compared with BSC alone (hazard ratio of 0.67; p<0.05). The trial completed enrollment
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SOURCE Poniard Pharmaceuticals, Inc.
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