FDA News

Poniard Pharmaceuticals Announces Treatment Of First Patient With Picoplatin In Pivotal Phase 3 Small Cell Lung Cancer Trial

(May 2, 2007)-- Poniard Pharmaceuticals, a biopharmaceutical company focused on oncology, announced treatment of the first patient with picoplatin in its pivotal Phase 3 clinical trial in small cell lung cancer (SCLC). Picoplatin, the Company's lead product candidate, is a new generation platinum therapy with an improved safety profile designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. The Phase 3 trial, known as SPEAR (Study of Picoplatin Efficacy After Relapse), received a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA).

"With the initiation of our Phase 3 SPEAR trial, our goal is to obtain regulatory approvals to bring picoplatin to market to address the critical unmet medical need in small cell lung cancer. Our SPA agreement with the FDA supports our plan to conduct a single pivotal Phase 3 trial that evaluates overall survival as the primary endpoint as a basis for filing for FDA approval to market picoplatin," said Jerry McMahon, Ph.D., chairman, president and CEO of Poniard. "We currently estimate that it will take approximately 20 months to complete enrollment and follow up in the SPEAR trial, potentially enabling us to file a New Drug Application in 2009."

Share or bookmarklet this web page at: