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Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Date:9/5/2007

and obtaining the approvals required to make picoplatin available to this severely underserved patient population."

About Fast Track Designation

The fast track programs of the FDA are designed to facilitate the development and expedite the review of drugs and biologics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designation enables the product candidate to become approved and reach the market expeditiously. This may include priority review (i.e., six-month versus the standard ten-month review) and the option to submit a New Drug Application on a rolling basis, enabling FDA to begin reviewing sections of the application before receiving the complete application. According to the FDA, picoplatin is eligible for Fast Track designation due to the unmet medical need -- with no approved therapy for refractory disease, responses seen in two Phase 2 studies, and Poniard's randomized, controlled Phase 3 trial of picoplatin and best supportive care (BSC) versus BSC alone.

About Picoplatin

Picoplatin is a new generation platinum chemotherapy agent. It was designed to overcome platinum resistance and to prolong the time to relapse after chemotherapy in the treatment of solid tumors, and to have an improved safety profile compared with existing platinum-based chemotherapeutics. Poniard received orphan drug designation from the FDA in November 2005 for picoplatin for the treatment of SCLC.

In addition to the SPEAR trial of intravenous picoplatin in SCLC, Poniard is also evaluating intravenous picoplatin in an ongoing Phase 1 clinical trial as a first-line treatment for metastatic colorectal cancer and in an ongoing Phase 2 trial in combination with docetaxel (Taxotere(R)) and prednisone in patients with metastatic hormone-refractory prostate cancer. Oral picoplatin is being evaluated in a Phase 1 clinical trial in solid tumors.

About Small Cell
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SOURCE Poniard Pharmaceuticals, Inc.
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