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Independent Data Monitoring Committee Supports Continuation of Picoplatin Phase 3 SPEAR Registration Trial in Small Cell Lung Cancer
Date:5/5/2009

(SPA)

SPEAR is an international, multi-center, randomized, controlled, pivotal Phase 3 trial of picoplatin in patients with SCLC who were refractory to or progressed within six months of first-line, platinum-containing chemotherapy. Patients are randomized two to one to receive picoplatin plus BSC verses BSC alone. The initial dose of picoplatin is 150 mg/m squared administered as an intravenous infusion once every three weeks. BSC is designed in accordance with the National Comprehensive Cancer Network's guidelines and includes analgesics, radiation therapy for painful bone metastases, brain metastases or relief of obstructive symptoms from lesions in the chest, nutritional support and treatment of anemia, dyspnea, infections, paraneoplastic syndromes, anxiety or other clinical problems. The primary endpoint of SPEAR is overall survival. Secondary endpoints include overall response rate, progression-free survival, disease control rate and duration of response. The enrollment target for SPEAR was reached and a total of 401 patients were enrolled from over 100 sites worldwide as of March 31, 2009.

The SPEAR study design is agreed to by the U.S. Food and Drug Administration (FDA) under a SPA. Fast Track designation was granted by the FDA and an Orphan Drug designation was granted by the FDA and European Medicines Agency. The study is 90 percent powered to show a 33 percent reduction in risk in overall survival for the treatment arm compared to BSC alone (hazard ratio = 0.67) (p < 0.05). Our Phase 2 study in resistant or refractory disease or patients who relapsed within 180 days of first-line platinum therapy, demonstrated that patients treated with picoplatin showed a median overall survival of 27 weeks(1). Historical data indicates that BSC treatment of patients with recurrent SCLC have a median overall survival of 14 weeks(2). Based on patient enrollment data, the Company believes that overall survival data will be available from t
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SOURCE Poniard Pharmaceuticals, Inc.
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