Sanofi-Aventis announces phase III trial for BSI-201

Sanofi-Aventis has announced the start of a phase III trial for its investigational drug BSI-201, in tandem with chemotherapy, in patients that have metastatic triple-negative breast cancer (mTNBC).

In a statement, the firm explained that BSI-201 inhibits poly (ADP-ribose) polymerase (PARP1), which is an enzyme that is associated with DNA damage repair.

The multi-centre randomised trial is designed to evaluate the efficacy and safety of the treatment in combination with gemcitabine and carboplatin in a total of 420 female patients who have mTNBC.

Between 60 and 75 sites are predicted to take part in the study.

Co-primary objectives of the study are to assess overall survival as well as improvement in progression-free survival.

“The secondary objectives are to assess objective response rate and safety,” Sanofi-Aventis concluded.

Earlier this month, the organisation issued an expert statement from a panel of international experts regarding an assessment of the firm’s Lantus (insulin glargine [rDNA] injection) treatment in the journal Diabetologia.