Product Pipeline

BSI-201 (iniparib*) is being studied in multiple cancers.  In January 2011, an announcement of top-line results showed that the Phase III trial of iniparib combined with chemotherapy (gemcitabine and carboplatin) to treat metastatic triple negative breast cancer (mTNBC) did not meet pre-specified criteria for significance for the co-primary endpoints of overall survival and progression-free survival.  A pre-specified sub-group analysis of patients treated in the second- and third-line setting suggests possible improvement in overall survival and progression-free survival in this population.  The overall safety analysis indicates that the addition of iniparib did not substantially add to the toxicity profile of gemcitabine/carboplatin alone. 

Iniparib is also being studied in a Phase III trial to address the needs of patients with advanced squamous cell lung cancer which accounts for 25-30% of lung cancer.  Iniparib is also in Phase II development for ovarian cancer and a number of other cancers.  Iniparib is the subject of an extensive translational and research program designed to better define the mechanism of anti cancer action of iniparib and to identify biomarkers predictive of response both within and across tumor types.

* Iniparib is the United States Adopted Name (USAN) for this compound.