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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

mulative platelet and neutrophil toxicity and mild diarrhea. Grade 1 neuropathy was observed in three patients, and no neuropathy higher than grade 1 was observed in any patients, including four patients who have received a cumulative dose >900 mg/m2. Transient grade 3-4 neutrophil toxicity occurred in 32 percent of patients and platelet toxicity in 13 percent of patients. Hematologic toxicity was more frequent in the every-two- week schedule. In the every-four-week schedule, no dose-limiting toxicity has been observed with doses of picoplatin up to 180 mg/m2. Picoplatin was administered at doses up to 90 mg/m2 every two weeks and 180 mg/m2 every four weeks. Both the biweekly and monthly regimens are still being evaluated to define their respective maximum tolerated doses.

Phase 1 HRPC Trial Data

The Phase 1 component of the HRPC trial is being conducted in patients with metastatic disease who had not previously been treated with chemotherapy. Study participants received either docetaxel 60 mg/m2 every three weeks plus prednisone 5 mg twice daily plus picoplatin or docetaxel 75 mg/m2 every three weeks plus prednisone 5 mg twice daily plus picoplatin. Picoplatin was given to sequential cohorts of subjects at 60, 80, 100 and 120 mg/m2 with docetaxel 60 mg/m2 and at 100 and 120 mg/m2 with docetaxel 75 mg/m2.

To date, 26 patients have been treated; four patients have completed 10 cycles of therapy and 15 patients remain on treatment. Therapy has been well tolerated, with transient grade 3-4 neutropenia occurring in 46 percent of patients and grade 3-4 thrombocytopenia in 8 percent of patients. Dose- limiting toxicity (grade 4 neutropenia) has been observed at 120 mg/m2 when given with 60 mg/m2 docetaxel. Dose reduction for persistent hematologic toxicity has been infrequent for doses less than 120 mg/m2 picoplatin, and there has been no cumulative myelotoxicity. Dose escalation continues with picoplatin with docetaxel at 75 mg/m2.

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