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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

l. Patients received gemcitabine/carboplatin alone (chemotherapy group) or in combination with iniparib (BSI-201) until disease progression or unacceptable toxicity. Patients in the chemotherapy group whose disease progressed were allowed to cross over to the iniparib (BSI-201) plus chemotherapy group. Efficacy analyses were conducted on the intent-to-treat (ITT) population.

About IniparibIniparib (BSI-201) is a novel investigational anti-tumor agent with poly (ADP-ribose) polymerase (PARP) inhibitory activity in preclinical models. Iniparib (BSI-201) is in phase III trials for patients with mTNBC and squamous non-small cell lung cancer, as well as in phase II trials for patients with ovarian, uterine and brain cancers.

The U.S. Food and Drug Administration (FDA) granted Fast Track designation to iniparib (BSI-201) for mTNBC. The regulatory submissions are planned for Q1 2011 in the United States and Q2 2011 in the European Union.

About Triple-Negative Breast Cancer (TNBC)When patients are diagnosed with breast cancer, their tumors are routinely tested for the presence of estrogen and progesterone receptors and for the over-expression of HER2. However, 15 to 20 percent of all breast cancers lack over-expression of all three proteins – giving rise to the term "triple negative breast cancer" or TNBC. Research has shown TNBC can be difficult to treat, leading the disease to be associated with poorer outcomes than other types of breast cancer. Women with TNBC are not candidates for hormonal therapy such as tamoxifen or the targeted therapy Herceptin, leaving chemotherapy as the standard treatment.

About sanofi-aventis Oncology Sanofi-aventis Oncology is targeting cancer on many fronts in an effort to address unmet medical needs for a broad range of patients. Starting with a deep understanding of the mechanisms by which cancer develops, grows and spreads, as well as identifying the right science early in the discovery process, t
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