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Poniard Announces Publication of Results of Picoplatin Phase 2 Study in Journal of Clinical Oncology
Date:4/20/2009

to the rapid relapse of the disease and the slim chance that patients will experience long-term survival," said John Eckardt, M.D., lead author of the JCO publication, picoplatin clinical trial investigator, and chief medical officer of DAVA Oncology. "I am encouraged that picoplatin extended survival in this patient group and was generally well tolerated. Data from the Phase 3 SPEAR trial in the same patient population will further clarify the potential of picoplatin as a viable treatment for patients with this highly lethal type of cancer."

Phase 2 Study Design and Results

The open-label, multi-center Phase 2 trial was designed to confirm the clinical activity and safety of picoplatin as second-line therapy in patients with platinum-refractory disease or platinum-resistant or platinum-sensitive disease that had progressed within six months after first-line treatment with a platinum-based chemotherapy, such as cisplatin or carboplatin. Efficacy endpoints included response rates, progression-free survival, overall survival, improvement in disease-related symptoms and disease control (defined as complete response, partial response and stable disease). The trial was conducted at clinical sites in North America and Eastern Europe.

A total of 77 patients received picoplatin. Median overall survival was 27 weeks following picoplatin administered once every three weeks. Median progression-free survival was 9 weeks. The six-month and one-year survival rates were 51 percent and 17 percent, respectively. The disease control rate was 47 percent in the 77 evaluable patients. The most common side effects observed were hematologic and included thrombocytopenia, neutropenia and anemia. No grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred in the study.

"The publication of these clinical findings in JCO represents an important milestone for Poniard. The positive
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SOURCE Poniard Pharmaceuticals, Inc.
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