Poniard Pharmaceuticals Reports First Quarter 2009 Financial Results and Provides a Corpor...(ollment target and a total of 401 patien...),Health

Date:5/5/2009

ollment target and a total of 401 patients were enrolled in the SPEAR (Study of Picoplatin Efficacy After Relapse) trial. The global, pivotal Phase 3 SPEAR trial is evaluating the efficacy and safety of picoplatin in patients with refractory or progressive small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy regiments or who have progressed within six months of first-line therapy. Patients were enrolled at more than 100 clinical trial sites in 16 countries in Europe, South America and Asia.

In May, the Company announced that the independent Data Monitoring Committee, after review of available information regarding the efficacy, safety and quality of trial conduct, recommends that the SPEAR trial continue.

Colorectal Cancer

• In April, final data from a Phase 1 dose-escalation study of picoplatin in patients with metastatic colorectal cancer (CRC) was presented at the American Association for Cancer Research's (AACR) 100th Annual Meeting 2009. Results demonstrated that picoplatin can be safely administered in combination with 5-fluorouracil and leucovorin in the FOLPI regimen as a first-line treatment for CRC. Based on the clinical activity and promising safety data observed in the Phase 1 study, Poniard initiated a randomized, controlled, proof-of-concept Phase 2 trial in November 2007 to evaluate picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC. Patient enrollment was completed in May 2008.

Oral Picoplatin

• In April, final data from a Phase 1 clinical study of an oral formulation of picoplatin in patients with solid tumors was also presented at the AACR Annual Meeting. Results showed that the bioavailability of oral picoplatin is nearly 100 percent at doses of 50 mg and 100 mg, indicating sufficient bioavailability
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SOURCE Poniard Pharmaceuticals, Inc. Copyright©2009 PR Newswire. All rights reserved

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