Cancer Therapy

Poniard Pharmaceuticals receives assessment for Phase III Trial of picoplatin

Published in Lab Law Weekly, February 2nd, 2007

Poniard Pharmaceuticals, Inc. (PARD) received a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) for its pivotal Phase III SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin for the treatment of small cell lung cancer (SCLC).

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 SCLC.

"This SPA agreement with the...

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Source: Lab Law Weekly (2007-02-02)

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