Date: 2017-12-22
Type of
information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Redhill Biopharma (Israel)
Product: Yeliva™ (ABC294640)
Action
mechanism:
- enzyme inhibitor/sphingosine kinase-2 (SK2) inhibitor. ABC294640 is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting a number of potential inflammatory, oncology and gastrointestinal indications. By inhibiting the SK2 enzyme, ABC294640 blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. ABC294640 has completed multiple successful pre-clinical studies in inflammatory, GI, radioprotection and oncology models, as well as a Phase I clinical study in cancer patients with advanced solid tumors. Yeliva™ was originally developed by U.S.-based Apogee Biotechnology.
- Yeliva® was granted FDA Orphan Drug designation for the treatment of cholangiocarcinoma.
Disease: cholangiocarcinoma
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
Latest
news:
- • On December 22, 2017, RedHill Biopharma announced the initiation of a Phase IIa study with Yeliva® (ABC294640) for the treatment of cholangiocarcinoma. The single-arm Phase IIa study will evaluate Yeliva® as a single agent in patients suffering from advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma. The study is planned to enroll up to 39 patients at Mayo Clinic major campuses in Arizona and Minnesota and at The University of Texas MD Anderson Cancer Center. Dr. Mitesh J. Borad, Associate Professor of Medicine and Director of Phase I Drug Development at the Mayo Clinic Cancer Center in Arizona, will act as Principal Investigator of the study. Dr. Borad also serves as a consultant to the Division of Hematology/Oncology,
- Following an extensive pre-clinical program, a Phase I clinical study with Yeliva® in patients with advanced solid tumors successfully met its primary and secondary endpoints,
Is
general: Yes
