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Poniard Pharmaceuticals Announces Progression-Free Survival Data From Phase 2 Clinical Trial of Picoplatin in Metastatic Colorectal Cancer
Date:5/28/2009

nths for those who received modified FOLFOX-6, containing oxaliplatin.
  • Of the 51 patients in the FOLPI treatment arm, 75 percent achieved disease control (defined as complete response, partial response or stable disease); two patients with a complete response, nine patients with a partial response and 27 patients with stable disease. In the FOLFOX treatment arm of 50 patients, 76 percent achieved disease control; three patients with a complete response, 11 patients with a partial response and 24 patients with stable disease.
  • Only 29 percent of the patients who received FOLPI showed evidence of neurotoxicity compared with 60 percent of patients treated with FOLFOX. In addition, 16 percent of FOLFOX-treated patients exhibited severe (Grade 3/4) neurotoxicity, whereas no FOLPI-treated patients showed evidence of severe neurotoxicity. Three different measurements of neuropathy were statistically significant for FOLPI as a potential neuropathy-sparing alternative to FOLFOX (p<0.0019).
  • With regard to hematologic toxicities, thrombocytopenia and neutropenia were more frequent and severe with the FOLPI regimen compared with FOLFOX. However, only one episode of febrile neutropenia and no bleeding complications have been observed to date. In addition, 83 percent of the planned picoplatin dose of 150 mg/meter squared was able to be delivered monthly in the 51 patients treated in the FOLPI treatment arm of the trial.
  • Nonhematologic adverse events, including gastrointestinal toxicity, were similar between the treatment groups, with the exception of alopecia, which occurred more frequently with FOLPI.

    • "We continue to be encouraged by these interim, proof-of-concept Phase 2 safety and efficacy results, which suggest the potential of picoplatin in FOLPI as a neuropathy-sparing therapeutic alternative to the use of FOLFOX for the first-line treatment of metast
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    SOURCE Poniard Pharmaceuticals, Inc.
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