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Study Shows Ixabepilone Demonstrated Clear Activity in Patients,with Metastatic Breast Cancer Resistant to Anthracycline, Taxane,,and Capecitabine

sion-free survival (PFS), and overall survival (OS), and with the exception of OS, analyses were based on IRF data. Response-evaluable patients were defined as patients with measurable disease, as determined by the IRF, which met the resistance criteria for anthracyclines, taxanes, and capecitabine. Results of the 113 response-evaluable patients were assessed by the IRF, as well as independently by investigators at the study site, and showed:

    -- Objective response rate was achieved in 11.5% of patients as determined

       by the IRF and 18.6% as determined by the investigators.

    -- Median duration of response of 5.7 months.

    -- Median time to response of 6.1 weeks.

    -- Median progression-free survival of 3.1 months.

    -- Median overall survival of 8.6 months.

Overall treatment-related non-hematological adverse events greater than or equal to 20% included: peripheral sensory neuropathy 60% (Grade 3/4: 14%); fatigue/asthenia 50% (Grade 3/4: 14%); myalgia/arthralgia 49% (Grade 3/4: 8%); alopecia 48% (Grade 3/4: 0%); nausea 42% (Grade 3/4: 2%); stomatitis/mucositis 29% (Grade 3/4: 7%); vomiting 29% (Grade 3/4: 1%); diarrhea 22% (Grade 3/4: 1%); and musculoskeletal pain 20% (Grade 3/4: 3%). Treatment-related hematological adverse events greater than or equal to 20% included: leukopenia 90% (Grade 3/4: 49%); anemia 84% (Grade 3/4: 8%); neutropenia 79% (Grade 3/4: 54%); and thrombocytopenia 44% (Grade 3/4: 8%).

About Ixabepilone

Ixabepilone is an investigational compound, a semisynthetic analog of epothilone B, designed to inhibit or prevent the growth or development of cancer cells. Epothilones are a potential new class of antineoplastic (or chemotherapy) agents. For information on ixabepilone clinical trials, log on to www.clinicaltrials.gov.

On June 19, 2007 the company announced that the U.S. Food and Drug Administration has accepted, for filing
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