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Poniard Pharmaceuticals Announces Promising Data From Interim,Safety Analysis of Phase 1 Combination Trials of Picoplatin in,Colorectal and Prostate Cancers

les either in combination with docetaxel for prostate cancer or with 5-fluorouracil and leucovorin for colorectal cancer. We anticipate that the Phase 2 trials for both indications will begin in the third quarter of 2007, shortly after the maximum tolerated doses have been defined."

He added, "In the Phase 1 colorectal cancer study, only three patients have experienced grade 1 neuropathy to date. There has been no neuropathy greater than grade 1 in all patients treated, including four patients who have received a cumulative picoplatin dose of greater than 900 mg/m2. The objective of our planned Phase 2 trial is to confirm the neuropathy-sparing properties of picoplatin given once every two weeks in a randomized trial compared to oxaliplatin and to enable a Phase 3 clinical trial to show superior safety and efficacy of FOLPI (picoplatin combined with fluorouracil and leucovorin) compared to FOLFOX (oxaliplatin combined with fluorouracil and leucovorin). The goal of our planned Phase 2 study in prostate cancer is to generate proof-of-concept data demonstrating that picoplatin has improved efficacy with docetaxel and to enable future picoplatin combination studies with taxanes for prostate and other cancer indications."

Phase 1 CRC Trial Data

The Phase 1 component of the CRC trial was designed to identify the maximum tolerated dose of picoplatin administered every two or four weeks with fluorouracil and leucovorin administered every two weeks. The starting dose of picoplatin for the every-two-week regimen was 45 mg/m2. In subsequent cohorts, picoplatin was increased by 15 mg/m2. The starting dose of picoplatin for the every-four-week regimen was 60 mg/m2. In subsequent cohorts, picoplatin was increased by 30 mg/m2 until dose-limiting toxicity established the maximum tolerated dose.

To date, 40 patients have been treated and have received up to 10 months of therapy. Therapy has been well tolerated with infrequent dose delays because of non-cu
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