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news.Poniard Pharmaceuticals has received a special protocol assessment agreement from the FDA for its phase III trial of picoplatin for the treatment of small cell lung cancer.
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Picoplatin, the company’s lead product candidate, is a new generation platinum therapy with an improved safety profile. It is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. Poniard received orphan drug designation in November 2005 from the FDA for picoplatin for the treatment of small cell lung cancer (SCLC).
The single phase III trial is designed to evaluate overall survival as the primary endpoint in order to rapidly achieve US approval for picoplatin for the treatment of patients with small cell lung cancer who currently are severely underserved.
Based on the positive interim median overall survival data from Poniard’s ongoing phase II clinical trial of picoplatin in patients with SCLC, the company plans to initiate the phase III trial in the first half of 2007. The primary endpoint will be overall survival. Overall response rates, progression-free survival and disease control also will be evaluated. Poinard expects to file a new drug application for the SCLC indication in 2009.
In November 2006, Poniard announced interim median overall survival data from its ongoing phase II clinical trial. The analysis showed a median overall survival of 26.7 weeks in the 72 patients treated with picoplatin.