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Poniard Pharmaceuticals Initiates Randomized Phase 2 Trial of Picoplatin for First-Line Treatment of Metastatic Colorectal Cancer
Date:11/1/2007

tion can be administered safely in this patient population. In the trial, no neuropathy greater than grade 1 has been observed in all patients treated, including four patients who received a cumulative picoplatin dose of greater than 900 mg/m2. The Company plans to present data from the Phase 1 trial at scientific meetings in 2008.

The platinum therapy oxaliplatin is an integral component of chemotherapy regimens which have become a standard treatment for metastatic 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.

Phase 2 Colorectal Cancer Trial Design

The Phase 2 trial will include 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 oxaliplatin in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen. The trial will evaluate whether FOLPI demonstrates equivalent or better efficacy than FOLFOX without the substantial neurotoxicity associated with oxaliplatin. Efficacy and safety assessment will include objective tumor response, duration of response, progression-free survival, overall survival and assessment of peripheral neuropathy. The trial will be conducted at approximately 25 clinical sites and is expected to complete enrollment in the first half of 2008. The Company currently expects to have early tumor response data and long-term safety data in the first half of 2008 and intends to submit the data for presentation at scientific confere
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SOURCE Poniard Pharmaceuticals, Inc.
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