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Positive Phase II Results with Iniparib (BSI-201) in Women with Metastatic Triple Negative Breast Cancer Published in The New England Journal of Medicine
Date:1/5/2011

emotherapy group (95% CI (0.39-0.90) HR=0.59, P=0.01). The overall response rate was 52 percent in the iniparib (BSI-201) group versus 32 percent (P=0.02) in the chemotherapy group alone. Although it was not a pre-specified endpoint of the trial, median overall survival among women who received iniparib (BSI-201) was 12.3 months, compared with 7.7 months among women who received chemotherapy alone – translating to a 43 percent reduction in the risk of death (95% CI, (0.36-0.90) HR=0.57, P=0.01).

In the phase II iniparib (BSI-201) study, the most common any grade adverse events in the iniparib (BSI-201) arm were neutropenia, anemia, thrombocytopenia, fatigue/asthenia, nausea and constipation. The most common grade 3/4 adverse events in the iniparib treatment arm were neutropenia, anemia, thrombocytopenia, leukopenia and fatigue/asthenia. There were two fatal adverse events (3.4%) in the chemotherapy-alone group and three (5.3%) in the iniparib (BSI-201) group, all attributed to disease progression within 30 days of receiving study treatment.  A large phase III study is ongoing and results are expected in 2011.

"The positive iniparib phase II data in this difficult to treat form of breast cancer is encouraging and underscores the innovative science and approach we have taken as we continue to investigate iniparib's potential to address this unmet medical need," said Atul Dhir M.D., CEO, BiPar Sciences, a wholly- owned subsidiary of sanofi-aventis.

About the Phase II Iniparib StudyThis multicenter, open-label, randomized study included 123 women with mTNBC. The primary endpoints were safety and tolerability and clinical benefit rate of iniparib (BSI-201) defined as a complete or partial response or stable disease of at least six months. Secondary endpoints included overall response rate and progression-free survival. Overall survival also was assessed, although it was not a pre-specified endpoint of the tria
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SOURCE sanofi-aventis
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