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Poniard Pharmaceuticals Announces European Commission Grants Orphan Medicinal Product Designation to Picoplatin for Treatment of Small Cell Lung Cancer
Date:10/17/2007

onically debilitating condition that affects no more than five in 10,000 persons in the European Union.

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 Lung Cancer

SCLC is the most aggressive and deadly form of lung cancer and accounts for approximately 20 percent of all lung cancer cases. The current two-year survival rate for patients with extensive SCLC is less than 10 percent with current management options. The estimated incidence of lung cancer in the United States in 2006 was 174,500, according to the National Cancer Institute. The estimated incidence in Europe in 2006 was 386,300, according to the International Agency for Research on Cancer.

SCLC is currently treated with platinum therapies, but many patients do not respond, and if they do respond, they typically relapse within a short time after treatment. There is currently no FDA-approved therapy and no consistent and effective therapy for SCLC patients who have platinum-resistant or -refractory disease after treatment failure with first-line combination therapy with either cisplatin or carboplatin. No new drugs have been approved by the FDA for th
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SOURCE Poniard Pharmaceuticals, Inc.
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