Small Cell Lung Cancer (SCLC)
Small cell lung cancer (SCLC) is the most aggressive and deadliest form of lung cancer and accounts for approximately 20 percent of all lung cancer cases. Approximately 35,000 patients in the U.S. and 33,000 patients in the EU will be diagnosed with SCLC this year. SCLC is currently treated first-line with platinum therapies, but many patients do not respond. If they do respond, they typically relapse within a short time after treatment. There is currently no consistent and effective therapy for SCLC patients who do not respond or who relapse early from first-line therapy with either cisplatin or carboplatin.
Poniard's Phase 2 open-label, multi-center trial of intravenous picoplatin in small cell lung cancer was designed to confirm and expand data supporting the efficacy of picoplatin as a single agent in the treatment of patients with platinum-refractory or -resistant small cell lung cancer. Results presented in September 2007 confirmed and extended a median overall survival of 27 weeks for patients treated with picoplatin.
A pivotal Phase 3 trial of intravenous picoplatin, known as SPEAR (Study of Picoplatin Efficacy After Relapse), in SCLC is ongoing. This registrational trial is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) and is evaluating overall survival as the primary endpoint. This international, multi-center, randomized, controlled trial is enrolling patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum-containing chemotherapy (cisplatin or carboplatin). The primary efficacy endpoint is overall survival. Overall response rates, progression-free survival and disease control also will be evaluated. The trial has a 2:1 randomization comparing the efficacy and safety of intravenous picoplatin plus best supportive care to best supportive care alone. The Company expects to enroll approximately 400 patients in the trial, which is being conducted at clinical sites in Europe and India. We are targeting commercialization of picoplatin in 2010.
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