13.07.2015 14:24:55

Blueprint Receives FDA Nod To Proceed With Clinical Trials For 2 Drug Candidates

(RTTNews) - Blueprint Medicines (BPMC) Monday said the U.S. Food and Drug Administration accepted the company's Investigational New Drug applications to begin Phase 1 clinical trials for its two lead drug candidates: BLU-554 and BLU-285.

BLU-554 is for the treatment of advanced hepatocellular carcinoma or HCC and cholangiocarcinoma, and BLU-285 is for unresectable, treatment-resistant gastrointestinal stromal tumor or GIST.

Blueprint is also on track to file an IND for BLU-285 in systemic mastocytosis.

BLU-554 is a potent and selective inhibitor of fibroblast growth factor receptor 4 or FGFR4. Aberrant signaling of FGFR4 is a disease driver in up to 30 percent of HCC patients. It may also play a role in a subset of patients with cholangiocarcinoma, a related cancer of the biliary duct.

HCC is the most prevalent form of liver cancer. Liver cancer is the second-leading cause of cancer-related deaths worldwide.

BLU-285 is a potent and selective inhibitor of KIT Exon 17 and PDGFR-alpha D842V mutants, which are key disease drivers of metastatic and treatment-resistant GIST, which is the most common form of sarcoma of the gastrointestinal tract.

Patients with the KIT Exon 17 and PDGFR-alpha D842V mutants are not adequately treated with existing therapies.

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