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Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing
Date:7/21/2009

SOUTH SAN FRANCISCO, Calif., July 21 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on innovative oncology therapies, today announced results from a Phase 1 cardiac safety study of picoplatin, a new generation platinum-based chemotherapy agent and the Company's lead product candidate. The Company worked collaboratively with the U.S. Food and Drug Administration (FDA) to design this study, which is required for new chemical entities.

This study evaluated the cardiac safety of picoplatin by determining its effect on the cardiac QT/QTc interval by using time-matched pharmacokinetics and electrocardiograms (ECGs). A total of 45 patients with advanced solid malignancies received 150 mg/m2 picoplatin. The trial was conducted at seven clinical sites in the United States. Results showed no clinical cardiac-related events. In addition, no evidence of a clinically relevant trend in any ECG parameter was demonstrated.

"With these new picoplatin safety data, we continue to make progress toward our goal of initiating the filing in 2009 of a New Drug Application for picoplatin as a second-line treatment for small cell lung cancer, with approval and commercialization targeted for 2010," said Robert De Jager, M.D., chief medical officer of Poniard. "More than 1,100 cancer patients have received picoplatin in clinical studies to date. Additional safety and anticipated efficacy data from our ongoing Phase 3 SPEAR study will provide a strong database to support the NDA filing."

The Company plans to present data from the Phase 1 cardiac safety trial at a medical conference later this year.

About Picoplatin

Picoplatin is a new generation platinum-based chemotherapy agent that is in clinical dev
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SOURCE Poniard Pharmaceuticals, Inc.
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