Sanofi-aventis and its wholly-owned subsidiary, BiPar Sciences, announced that the clinical development programme in metastatic triple-negative breast cancer (mTNBC) for the investigational PARP1 inhibitor, BSI-201, progresses as planned with the phase-3 study meeting expectations on patient accrual and trial site coverage in the United States. Study investigators have enrolled 214 of the target number of 420 patients.
BSI-201 entered a phase-3 clinical trial in the United States in July 2009 and is being evaluated in combination with chemotherapy in patients with mTNBC, a condition defined by tumours lacking expression of estrogen, progesterone receptors and without overexpression of HER2. BSI-201 is a novel investigational targeted therapy that inhibits poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.
The decision to commence with the phase-3 study in July was based on the encouraging phase-2 study results presented at ASCO on May 31, 2009. In the phase-2 clinical trial, women with mTNBC who were randomly assigned to receive gemcitabine and carboplatin (GC) in combination with the investigational agent BSI-201 or GC alone.
“The updated analysis from the phase 2 program, including data on overall survival, are consistent with the positive results presented earlier this year at ASCO,” declared Marc Cluzel, executive vice president, R&D, sanofi-aventis. “We are very encouraged by the fast recruitment of patients in
phase-3 trial. We hope the findings will lead to emerging strategy that may help women with metastatic triple negative breast cancer.”
The US Food and Drug Administration (FDA) granted Fast Track designation to BSI-201 for mTNBC. As described by the FDA, the Fast Track process is designed to expedite the review of drugs being developed for serious diseases with the potential to address an unmet medical need.
BSI-201 is a potential first-in-class investigational targeted therapy designed to inhibit poly (ADP-ribose) polymerase (PARP1), an enzyme involved in DNA damage repair.
BiPar Sciences is a biopharmaceutical organization dedicated to pioneering novel tumor-selective therapies designed to address urgent unmet needs of cancer patients.