Bipar Initiates Phase 3 Trial For BSI-201

BiPar has initiated the pivotal phase 3 trial for BSI-201 in combination with chemotherapy. The trial is on patients with metastatic triple-negative breast cancer (mTNBC), defined by tumors lacking expression of estrogen, progesterone receptors and without over-expression of HER2.

BSI-201 is a novel, investigational, targeted therapy which inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.

The phase 3 trial is a multi-center, randomized trial designed to evaluate the safety and efficacy of BSI-201, when combined with gemcitabine and carboplatin (GC) in women with mTNBC.

The company said that a total of 420 mTNBC patients, who have received 0-2 prior therapies in the metastatic setting, will be randomized to receive GC with or without BSI-201.

The co-primary objectives of this study are to assess improvement in progression-free survival and overall survival. The secondary objectives are to assess objective response rate and safety, said the company.