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news.Poniarda is likely to file New Drug Application for picoplatin as a second-line treatment for small cell lung cancer
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Poniard has reported the results of phase 1 cardiac safety study of picoplatin, a new generation platinum-based chemotherapy agent. The study evaluated the cardiac safety of picoplatin by determining its effect on the cardiac QT/QTc interval, by using time-matched pharmacokinetics and electrocardiograms (ECGs).
Repotedly, a total of 45 patients with advanced solid malignancies received 150 mg/m2 picoplatin. Results showed no clinical cardiac-related events. In addition, no evidence of a clinically relevant trend in any ECG parameter was demonstrated.
Robert De Jager, CMO of Poniard, said: With these new picoplatin safety data, we continue to make progress toward our goal of initiating the filing in 2009 of a New Drug Application for picoplatin as a second-line treatment for small cell lung cancer, with approval and commercialization targeted for 2010.
More than 1,100 cancer patients have received picoplatin in clinical studies to date. Additional safety and anticipated efficacy data from our ongoing Phase 3 SPEAR study will provide a strong database to support the NDA filing, he added.