Poniard Pharmaceuticals Completes Enrollment of Phase 2 Picoplatin Trial in Colorec...(en evaluated in more than 750 patients a...),Health

Phase 2 Study Details

The Phase 2 study is a two-arm, randomized, controlled 100-patient trial of first-line treatment of metastatic CRC. The objective of the Phase 2 trial is to compare the safety and efficacy of intravenous picoplatin given once every four weeks in the FOLPI regimen with oxaliplatin in combination with 5- fluorouracil and leucovorin in the modified FOLFOX-6 regimen and to evaluate clinical activity. Poniard expects to generate proof-of-concept data from the Phase 2 trial demonstrating that picoplatin has an improved safety profile. This trial could position picoplatin as the preferred platinum agent for the first-line treatment of metastatic colorectal cancer and could potentially enable a Phase 3 study.

-- Poniard initiated the Phase 2 trial in November 2007 based on clinical

activity and promising safety data observed in its 50-patient, Phase 1

dose-escalation study of picoplatin in the FOLPI regimen as a

first-line treatment for metastatic CRC. Results of the Phase 1 trial

were presented at the ASCO Gastrointestinal Cancers Satellite Symposium

in January and demonstrated that picoplatin has a manageable toxicity

in combination with 5-fluorouracil and leucovorin Picoplatin did not

cause severe neurotoxicity (Grade 3 or higher), as is commonly seen in

metastatic CRC patients treated with oxaliplatin as part of the FOLFOX

regimen. Current National Comprehensive Cancer Network (NCCN) Clinical

Practice Guidelines in Oncology for colon cancer encourage the

discontinuation of FOLFOX after three months of therapy or sooner if

significant neurotoxicity develops (Grade
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