Pharmion Initiates Pivotal Phase 3 Study of Amrubicin in Small Cell L...(ng on Day 1 of a 21-day cycle. Theprimar...),Health

Pharmion has completed the Scientific Advice (SA) process with the European Medicines Agency (EMEA) and has reached Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA) for the amrubicin Phase 3 SCLC study.

Interim findings from a Phase 2, multi-center clinical study of amrubicin in second-line sensitive SCLC patients provided encouraging initial results and informed the design of the pivotal study. These data were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2007. Response data from 24 evaluable patients were analyzed, 15 treated with amrubicin and nine with topotecan. Of the 15 amrubicin-treated patients, 40 percent showed an objective tumor response, including two complete responses and four partial responses. All responses were confirmed. None of the nine topotecan patients showed a response to the drug. The median duration of progression free survival at the interim analysis was 4.1 months for amrubicin patients compared to 2.0 months for topotecan patients. Patients are being followed for overall survival. The major toxicity of amrubicin is myelosuppression, which is managed with standard supportive therapy and dose adjustments.

In addition to the Phase 2 study in second-line sensitive SCLC patients, Pharmion has two additional ongoing Phase 2 studies of amrubicin therapy for small cell lung cancer patients; one as single-agent therapy in patients refractory to first-line therapy; and one as single-agent or combination therapy with cisplatin versus cisplatin plus etoposide in previously untreated extensive stage patients.

"The Phase 2 studies in small cell lung cancer, in both sensitive and refractory patients, have thus far generated data f
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