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Poniard Announces Positive Incremental Efficacy and Safety Data from Phase 2 Picoplatin Trial in Patients With Metastatic Colorectal Cancer
Date:10/22/2008

Of 51 patients in the FOLFOX arm, 23 achieved disease control, including five with partial responses (or 13 percent of evaluable patients). Nine patients in the FOLFOX arm were either not evaluable or too early to evaluate.

"These interim, proof-of-concept Phase 2 colorectal cancer study results are encouraging and continue to suggest the potential of picoplatin as a neuropathy-sparing first-line therapy for metastatic colorectal cancer," said Robert De Jager, M.D., chief medical officer of Poniard. "We are committed to developing picoplatin as a preferred platinum therapy for patients with metastatic colorectal cancer who cannot tolerate the toxicity profile of currently marketed platinums, and we are optimistic that the additional data from this trial support that strategy. We are continuing to observe the study population in order to obtain progression-free and overall survival data, potentially supporting the future development of picoplatin."

About Picoplatin

Picoplatin has an improved safety profile relative to existing platinum-based cancer therapies and is designed to overcome platinum resistance associated with chemotherapy in solid tumors. It is being studied in multiple cancer indications, combinations and formulations. Picoplatin has been evaluated in more than 750 patients and has demonstrated anti-tumor activity in multiple indications with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs.

In addition to the Phase 2 clinical trial in CRC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in small cell lung cancer. This registration trial currently is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration and is evaluating overall survival as the primary endpoint. Picoplatin is also being evalu
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SOURCE Poniard Pharmaceuticals, Inc.
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