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RECIST Response Rate Increases to 50% in gBRCA Breast Cancer; Study Ongoing
Phase 3 Trial to Start in 3Q 2013
National Breast Cancer Coalition Announces Intention to Assist With Trial Recruitment
SAN RAFAEL, Calif., July 25, 2013 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today provided an update on its ongoing Phase 1/2 study for its poly ADP-ribose polymerase (PARP) inhibitor BMN 673 for the treatment of solid tumors. As of July 24, the RECIST response rate from the ongoing trial is nine out of 18 breast cancer patients, or 50 percent, including one confirmed complete response. This response rate includes three additional confirmed responses since the last update at the ASCO Annual Meeting, and two new patients are yet to be confirmed. Four patients are ongoing with stable disease with potential for additional responses. The study is still ongoing, and the company will provide additional updates later this year, including data in ovarian cancer, Ewing's sarcoma and small cell lung cancer.
Since the ASCO Annual Meeting, the company has met with the FDA and MAA to review its planned clinical program in deleterious gBRCA mutation metastatic breast cancer. At those meetings, health authorities confirmed that a primary endpoint of Progression Free Survival (PFS) could serve as the basis for a potential approval. BioMarin now expects to initiate a Phase 3 trial for BMN 673 in deleterious gBRCA mutation metastatic breast cancer in late third quarter of 2013, earlier than previously announced at the ASCO Annual Meeting in early June.
National Breast Cancer Coalition (NBCC) has announced its intention to assist BioMarin's development of the PARP inhibitor for the treatment of hereditary breast cancer with BRCA mutations. NBCC intends to participate with BioMarin on enrollment initiatives in the United States and around the world. In addition, NBCC will be a resource on study design, implementation and execution.