BiPar Sciences , a subsidiary of sanofi-aventis, is advancing the field of cancer therapy through the development of a novel investigational anticancer agent, BSI-201 (iniparib).  Iniparib is the United States Adopted Name (USAN) for this compound.

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.

Modifications have been made to the Expanded Access Protocol (EAP) and to the current Named Patient Programme (NPP). Patients currently on iniparib and in either of these programs (EAP or NPP) will be provided with information about the protocol modifications by their treating physician.  Patients who have concerns or questions should contact their physician for additional information.