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news.Poniard Pharmaceuticals, a developer and marketer of cancer therapy products, has reported that the independent data monitoring committee, or DMC, after review of available information regarding the efficacy, safety and quality of trial conduct, has recommended the continuation of the Spear trial.
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Spear is an international, multi-center, randomized, controlled, pivotal Phase III trial of picoplatin in patients with small cell lung cancer (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 versus BSC alone. The initial dose of picoplatin is 150mg/sqm administered as an intravenous infusion once every three weeks.
Jerry McMahon, chairman and CEO of Poniard, said: “The recommendation by the DMC to continue our SCLC registration trial represents another milestone in the development of picoplatin as a potential new treatment option for SCLC patients.
“We are encouraged by the continued progress of the trial and remain on track to complete the clinical data analysis to support the initiation of a new drug application with the FDA this year.”