RedHill starts Phase II trial of Yeliva for cholangiocarcinoma

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) began an open-label, U.S. Phase IIa trial of Yeliva (ABC294640) to treat cholangiocarcinoma. The study is expected to enroll up to 39 patients with advanced, unresectable intrahepatic, perihilar or extrahepatic disease to receive twice-daily 500 mg oral Yeliva.

The trial's primary endpoint is rate of complete and partial responses plus stable disease lasting at least four months. Secondary endpoints include safety, Hospital Anxiety and Depress Scale (HADS) and Mini-Mental State Examination (MMSE) scores, pharmacokinetics, progression-free survival (PFS), disease control rate (DCR) every two months up to 24 months and overall survival (OS)...