Xconomy: FDA Grants Blueprint Go-Ahead for Kinase Inhibitor Trials
Summary
FDA Grants Blueprint Go-Ahead for Kinase Inhibitor Trials Xconomy Boston — Blueprint Medicines got the green light from the Food and Drug Administration to begin clinical trials on its two lead drug candidates for cancer, about two months after its initial public offering.Blueprint wants to develop compounds that block certain kinases—a family of hundreds of enzymes that can drive the activity of cancer cells—while avoiding others.With the go-ahead from the FDA to begin Phase 1 studies on drug candidates BLU-285 and BLU-554, Blueprint is taking its first strides toward developing an entire portfolio.BLU-285 targets the D816v mutation of the c-Kit gene, which plays a role in certain gastrointestinal tumors and in systemic mastocytosis, an abnormal buildup of mast cells, which normally help protect the body from disease.The company plans to enroll 60 patients in this trial as well, though 10 will be people who suffer from advanced, unresectable cholangiocarcinoma, a related cancer of the biliary duct, Blueprint said in a statement.