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Investigational Cancer Drug BSI-201 Showed Clinical Benefit in 62% of Patients with Triple-Negative Metastatic Breast Cancer and Significantly Prolonged Survival
Date:6/3/2009

ly, for women who received chemotherapy alone. The hazard ratios for progression free survival and overall survival were 0.342 (p< 0.0001) and 0.348 (p=0.0005), respectively.

The most common severe (grades 3 and 4) side effects included neutropenia [25/57 in patients treated with GC and BSI-201; 31/59 patients treated with GC alone], thrombocytopenia and anemia. No febrile neutropenia was observed in patients receiving BSI-201 combined with chemotherapy. BSI-201 did not add to the frequency or severity of adverse events associated with chemotherapy.

"The improvement in overall survival and progression free survival together with the responses seen in this study are promising. We did not observe added toxicities. BSI-201 may provide a potential new treatment option for patients suffering from this disease," said Joyce O'Shaughnessy, M.D., co-director of the Breast Cancer Research Program at Baylor-Charles A. Sammons Cancer Center and Texas Oncology in Dallas, Texas.

"These results represent an important development for a disease that currently has no approved standard of treatment," said Barry Sherman, M.D., BiPar's Executive Vice President of Development. "Further study of BSI-201 will help us determine its full therapeutic potential in triple negative breast cancer, as well as in other cancers".

BiPar Sciences and sanofi-aventis expect to begin a Phase 3 trial with BSI-201 in metastatic TNBC this summer.

About ASCO

ASCO is the world's leading professional organization representing physicians who care for people with cancer. Approximately 30,000 cancer specialists from around the world are expected to gather at ASCO to discuss the latest advances in cancer care, treatment, prevention and survivorship. More than 4,000 abstracts have been accepted to the meeting, which will focus on the theme of "Personalizing Cancer Care", a practice focusing on caring for the
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SOURCE Sanofi-aventis
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