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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

SOUTH SAN FRANCISCO, Calif., March 25 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, today announced that it has reached its enrollment target of 400 patients in the SPEAR (Study of Picoplatin Efficacy After Relapse) trial. This global, pivotal Phase 3 trial is evaluating the efficacy and safety of picoplatin in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. Patients have been enrolled at more than 100 clinical trial sites in 16 countries in Europe, South America and Asia.

"Completion of patient enrollment in our pivotal Phase 3 SPEAR trial represents an important milestone for Poniard. We accomplished this ahead of internal projections, which allows us to keep on schedule to complete the clinical data analysis and initiate the filing of a rolling New Drug Application with the U.S. Food and Drug Administration for picoplatin in SCLC this year," said Jerry McMahon, Ph.D., chairman and chief executive officer of Poniard. "We believe that picoplatin will provide a survival benefit for SCLC patients who have failed platinum-based therapy consistent with survival data we have previously generated in two independent Phase 2 trials. We also expect the data will show that picoplatin overcomes resistance in patients treated with current platinum-based chemotherapies. This would be a new use for a platinum chemotherapy agent. We are also continuing to analyze additional clinical data from our picoplatin Phase 2 trials in first-line treatment for metastatic colorectal and prostate cancers and will report on them later this year."

"We are pleased to have completed trial enrollment ahead of schedule," said Robert De Jager, M.D.
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SOURCE Poniard Pharmaceuticals, Inc.
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