Poniard Announces Publication of Results of Picoplatin Phase 2 Study in Journal of Clinica...(survival results of the Phase 2 picoplat...),Health

Date:4/20/2009

survival results of the Phase 2 picoplatin trial in this difficult-to-treat disease formed the basis of our decision to initiate the Phase 3 SPEAR trial for which we recently completed patient enrollment ahead of internal projections," said Robert De Jager, M.D., chief medical officer of Poniard. "We are on track to complete the clinical data analysis of the SPEAR trial and initiate the filing of a rolling New Drug Application with the FDA for picoplatin in SCLC this year. If approved, picoplatin could represent an important new treatment for SCLC. In addition, it potentially enables other trials of picoplatin in patients with other solid tumors who relapse or are refractory to first-line platinums, such as in non-small cell lung cancer and ovarian cancer."

About Picoplatin

Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors. Study data to date indicate that it has an improved safety profile relative to existing platinum-based cancer therapies. More than 1,100 patients have been treated with picoplatin. Results obtained to date suggest manageable hematologic adverse events with less severe kidney toxicity (nephrotoxicity) and nerve toxicity (neurotoxicity) than is commonly observed with other platinum chemotherapy drugs. Picoplatin has demonstrated anti-tumor activity in a variety of solid tumors. It is being studied in multiple cancer indications, treatment combinations and by two routes of administration.

The SPEAR trial is comparing picoplatin plus best supportive care, to best supportive care alone, to evaluate the efficacy and safety of picoplatin after relapse in SCLC patients. The primary efficacy endpoint is overall survival. Progression-free survival, overall response rate, and disease control are also being evaluated. The Company is currently evaluating picoplatin in two Phase 2 clinical trials -- one is evaluating the safety and efficacy of picoplatin in pa
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SOURCE Poniard Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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