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Sanofi-aventis Reports Top-line Results from Phase III Study with Iniparib (BSI-201) in Metastatic Triple-Negative Breast Cancer
Date:1/27/2011

he United States. Patients were randomized to receive a standard chemotherapy regimen (gemcitabine and carboplatin) on days one and eight of each 21-day cycle, with or without iniparib (BSI-201) 5.6 mg/kg, which was administered on days one, four, eight and 11 of each 21-day cycle. Patients in the study had received up to two previous lines of chemotherapy in a metastatic setting. The co-primary endpoints were overall survival and progression-free survival.

About Iniparib

Iniparib (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 squamous non-small cell lung cancer, as well as in Phase II trials for patients with breast, lung and other cancers.

* Iniparib is the United States Adopted Name (USAN) for the investigational agent BSI-201.

About Triple-Negative Breast Cancer (TNBC)

When women 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 continues to be difficult to treat and associated with poorer outcomes than other types of breast cancer. Women with TNBC are not candidates for hormonal therapies such as tamoxifen or therapies targeting the human epidermal growth factor receptor 2, such as Herceptin, leaving chemotherapy as the standard treatment. Therefore, finding new strategies to enhance the effectiveness of chemotherapy in this population has become an important research focus.

About BiPar Sciences

BiPar Sciences is a biopharmaceutical organization dedicated to pioneering novel tumor-selective therapies designed to address urgent unmet ne
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