Colorectal Cancer The platinum therapy oxaliplatin is an integral component of chemotherapy regimens that have become a standard treatment for metastatic colorectal cancer (CRC). The associated side effects, most notably neuropathy, can significantly impair the quality of life of patients and limits the optimal use of oxaliplatin. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology, discontinuation of oxaliplatin from the FOLFOX regimen (in which oxaliplatin is given in combination with 5-fluorouracil and leucovorin) should be strongly considered after three months of therapy, or sooner if significant neurotoxicity develops. Interim safety results from Poniard's Phase 1 trial in CRC showed that picoplatin given in combination with 5-fluorouracil and leucovorin - known as the FOLPI regimen - can be administered safely in colorectal cancer patients, with no neuropathy greater than grade 1. A randomized Phase 2 trial to evaluate the efficacy and safety, including neuropathy, of intravenous picoplatin in combination with 5-FU and leucovorin, FOLPI versus FOLFOX for the first-line treatment of metastatic colorectal cancer (CRC) is under way. The objective of this proof-of-concept trial is to demonstrate that picoplatin can be used as a first-line chemotherapeutic agent with a favorable toxicity profile compared to oxaliplatin and to generate data to support advancement to a Phase 3 registrational trial for this indication. The Phase 2 trial is evaluating approximately 100 patients with metastatic CRC randomized to either picoplatin (150 mg/m2) given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen or the current standard doses of oxaliplatin in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen. The trial is evaluating whether FOLPI has equivalent or better efficacy than FOLFOX without the substantial neurotoxicity associated with oxaliplatin. Efficacy and safety assessments include objective tumor response, duration of response, progression-free survival, overall survival and assessment of peripheral neuropathy. The Company enrolled the trial in the first half of 2008 and is presenting clinical data from the Phase 1 and Phase 2 CRC trials at scientific meetings throughout 2008.