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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

BRIDGEWATER, N.J., Jan. 5, 2011 /PRNewswire/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and its wholly-owned subsidiary, BiPar Sciences, today announced that The New England Journal of Medicine (NEJM) published the final phase II data for the investigational drug iniparib* (BSI-201) demonstrating significant clinical benefit in women with metastatic triple negative breast cancer (mTNBC) when iniparib was administered in combination with chemotherapy agents gemcitabine/carboplatin. Although not a pre-specified endpoint, overall survival also was significantly increased in women who received iniparib. The study, "Iniparib plus Chemotherapy in Metastatic Triple-Negative Breast Cancer," was published in the January 5, 2011, online version of the NEJM and will be published in the January 20, 2011, print edition.  These findings were presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

"These published data show that the addition of iniparib to gemcitabine and carboplatin provided a significant improvement in clinical benefit in women with metastatic triple negative breast cancer, an aggressive form of breast cancer with no approved standard treatments that target this particular tumor subtype," said Joyce O'Shaughnessy, M.D., lead investigator of the study and co-chair of the Breast Cancer Research Program, Baylor-Charles A. Sammons Cancer Center, Texas Oncology, US Oncology in Dallas.

According to the study results, 56 percent of patients in the iniparib (BSI-201) group showed a clinical benefit – defined as a complete or partial response or stable disease of at least six months – compared with 34 percent (P=0.01) of patients in the chemotherapy group alone. Median progression-free survival in the iniparib (BSI-201) group was 5.9 months compared with 3.6 months in the ch
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