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Poniard Announces Positive Incremental Efficacy and Safety Data From Ongoing Phase 2 Picoplatin Trial in Hormone-Refractory Prostate Cancer
Date:10/22/2008

Symposium on "Molecular Targets and Cancer" in Geneva, Switzerland. Picoplatin, the Company's lead product candidate, is a new generation platinum chemotherapy agent with the potential to become a platform product addressing multiple indications, combinations and formulations for the treatment of multiple solid tumor indications.

Phase 2 HRPC Trial Design and Preliminary Results

In the ongoing Phase 2 trial, the efficacy and safety of intravenous picoplatin (120 mg/m squared) administered every three weeks (21 days) in combination with full-dose docetaxel (75 mg/m squared) with daily prednisone (5 mg) as a first-line treatment are being evaluated in 30 patients with metastatic HRPC who have not received prior chemotherapy. PSA response (defined as a PSA reduction of at least 50 percent from baseline) is the primary endpoint; secondary endpoints include safety, response rate, time to progression and overall survival. The trial completed enrollment in December 2007.

Results presented at the Symposium showed a PSA response of at least 50 percent in 78 percent of the 27 evaluable patients and also showed that the combination of picoplatin and full-dose docetaxel can be safely administered. Manageable and reversible neutropenia were the main hematologic toxicities. In contrast to picoplatin monotherapy, thrombocytopenia was less severe and less frequent in combination with docetaxel. To date, no neurotoxicity has been observed in this study. These findings confirm and extend earlier Phase 2 results presented at the 44th Annual Meeting of the American Society of Clinical Oncology in May and results from the Phase 1 trial presented earlier this year.

"We are encouraged by the PSA decreases observed with picoplatin in combination with docetaxel to date and with the finding that picoplatin continues to be well tolerated in this Phase 2 proof-of-concept trial," said Robert De Jager, M.D., chief medical officer of Poniard. "Additional data from this
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SOURCE Poniard Pharmaceuticals, Inc.
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