Pharmion Initiates Pivotal Phase 3 Study of Amrubicin in Small Cell L...( BOULDER Colo. Oct. 17 /- Pharmion...),Health

BOULDER, Colo., Oct. 17 /PRNewswire-FirstCall/ -- Pharmion Corporation (Nasdaq: PHRM) today announced the initiation of an international pivotal Phase 3 clinical trial evaluating amrubicin, the Company's third-generation synthetic anthracycline, in the treatment of second-line small cell lung cancer (SCLC). The randomized, controlled, multi-center study will compare amrubicin to topotecan, the only approved chemotherapy for second-line treatment of SCLC in the US and EU. Enrollment in the study of 480 patients is underway.

Approximately 30,000 patients in the US and 32,000 patients in the EU will be diagnosed with SCLC this year. "The treatment of small cell lung cancer is extremely challenging, given the limited therapeutic options available," said Mark A. Socinski, Associate Professor of Medicine, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, and a principal investigator in the Phase 3 study. "Preliminary data suggest that amrubicin could represent a significant improvement in the treatment of small cell lung cancer, for which there have been no major medical advances in more than 20 years."

The study compares amrubicin and topotecan in second-line treatment of SCLC patients with sensitive or refractory disease. Sensitive disease is defined as response to first-line platinum-based therapy, with subsequent progression 90 days or more after completion of therapy. Refractory disease is defined as no objective response or progressive disease within 90 days of completion of therapy. Study participants are randomized in a 2:1 ratio to receive either IV amrubicin (40mg/m2 daily for 3 days) or topotecan (1.5 mg/m2 daily for 5 days), both starti
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