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Poniard Pharmaceuticals Announces Positive Tumor Response and Neuropathy Data from Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer
Date:1/14/2009

iple indications, combinations and formulations. The picoplatin data will be presented in a poster session Saturday, January 17th at 12:30 pm Pacific Time (abstract #444/poster #A56) during the American Society of Clinical Oncology's (ASCO) 2009 Gastrointestinal Cancers Symposium in San Francisco.

Phase 2 CRC Trial Design and Updated Results

The randomized, controlled Phase 2 trial is evaluating picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC in 101 patients who have not received prior chemotherapy. The trial is comparing the safety, including neuropathy, and efficacy of intravenous picoplatin given once every four weeks in combination with bi-weekly 5-fluorouracil and leucovorin (the FOLPI regimen) with oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen, which is the current standard of care. Severe neuropathy is commonly seen in CRC patients treated with oxaliplatin in combination with 5-fluorouracil and leucovorin as part of the FOLFOX regimen at cumulative doses above 800 mg/m squared.

The Phase 2 results, scheduled for presentation at the ASCO Symposium, showed that 65 percent of evaluable FOLFOX-treated patients showed evidence of neurotoxicity compared with 28 percent of patients treated with FOLPI. Ten percent of FOLFOX-treated patients exhibited severe (Grade 3/4) neuropathy compared with no FOLPI-treated patients. Nonhematologic adverse events, including acute gastrointestinal toxicity, were similar between the treatment groups. Thrombocytopenia and neutropenia were more frequent and severe with the FOLPI regimen, but manageable.

Anti-tumor activity also was similar in the FOLPI and FOLFOX groups. Of patients in the FOLPI arm, 76 percent achieved disease control (complete response, partial response and stable disease), including one patient with a complete response and seven patients with a
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SOURCE Poniard Pharmaceuticals, Inc.
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