BioMarin Pharmaceutical and Sarah Cannon Research Institute UK (SCRI UK)announced that they have partnered to recruit patients in the ongoing Phase III EMBRACA clinical trial of BioMarin’s BMN 673 for the treatment of hereditary breast cancer with a BRCA mutation. The trial was officially initiated in October 2013 when BioMarin dosed the first BMN 673 patient.
BMN 673 is a poly-ADP ribose polymerase (PARP) inhibitor. PARP is an enzyme implicated in DNA damage repair needed for certain tumor cells to survive. The lead compound has shown potent activity as a single agent in ovarian and breast cancer in patients who carry BRCA, as well as in patients with small cell lung cancer.
With SCRI UK’s enrollment of the first patient outside the U.S., the EMBRACA Phase III trial has expanded internationally. The open label, parallel, two-arm, multi center, randomized study will investigate BMN 673 against physician’s choice in an estimated 430 patients with germline BRCA mutation patients with locally advanced and/or metastatic breast cancer and who have undergone no more than two previous chemotherapy regimens for metastatic cancer. The trial’s primary objective is progression-free survival while secondary endpoints include overall survival and objective response rate.
Dr. Hendrik-Tobias Arkenau, Medical Oncologist and Medical Director at SCRI UK, said that the study is a stepping stone for building future partnerships with BioMarin. SCRI presented 10 clinical trial abstracts at the recent 2014 AACR Annual Meeting held in San Diego earlier this year.
Hank Fuchs, CMO of BioMarin, said that the company is delighted to work with its partner SCRI UK in conducting patient enrollment for EMBRACA outside the U.S. “Breast cancer patients with germline BRCA-associated tumors have no targeted treatment options. There is an unmet need for therapies that target specific molecular defects in tumors, and PARP inhibitors offer that potential in BRCA-related breast cancer,” he said.
Earlier this month, BioMarin received approval from Health Canada for Vimizim (elosulfase alfa) for the treatment of Morquio A Syndrome.