New clinical trial scheduled for BSI-201 for triple negative

Sanofi-aventis and its  subsidiary, BiPar Sciences, today announce  Phase 3 trial for BSI-201 in combination with chemotherapy in patients with metastatic triple-negative breast cancer.   BSI-201 is a targeted therapy that inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.

Results of the  Phase 2 study were presented at  the American Society of Clinical Oncology (ASCO) annual conference on May 31, 2009. The l trial involved 116 women with metastatic TNBC who were randomly assigned to receive GC in combination with the  BSI-201 or GC alone.

• 62 percent of patients receiving BSI-201 in combination with GC showed clinical benefit,

•  21 percent in the group receiving chemotherapy alone  benefitted.

•  48 percent of patients who received BSI-201 combined with chemotherapy had some level of tumor reduction.

* 16 percent of  those receiving chemotherapy alone had tumor reductions.

•  Women who received BSI-201 had a median progression-free survival of 6.9 months and overall survival of 9.2 months compared with 3.3 and 5.7 months for women who received chemotherapy alone. T

In the  Phase 3 trials, 60-75 sites will be distributed throughout the United States. All patients will  have the opportunity to receive BSI-201.

Read the news release here.