Date: 2016-10-05
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Redhill Biopharma (Israel) Apogee Biotechnology (USA - PA)
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.
Disease: hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is a Phase II efficacy study of single agent ABC294640. Patients with advanced hepatocellular carcinoma who have experienced tumor progression with 1st line single agent sorafenib will receive ABC294640 500 mg po bid continuously. Patients will continue on therapy until the development of progressive disease per modified RECIST, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation. Carolyn D. Britten, MD, Chief of the Division of Hematology/Oncology in the Department of Medicine at MUSC and Associate Director for Clinical Investigations at the MUSC Hollings Cancer Center, is the Principal Investigator for the Phase II study. (NCT02939807)
Latest
news: * On October 5, 2016, RedHill Biopharma announced that a Phase II clinical study evaluating Yeliva™ (ABC294640) in patients with advanced hepatocellular carcinoma has been initiated, with enrollment expected to
commence shortly, pending final regulatory clearance. The study will be conducted at the Medical University of South Carolina Hollings Cancer Center (MUSC) and additional clinical centers in the U.S. It is supported by
a $1.8 million grant from the National Cancer Institute (NCI) awarded to MUSC, intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, including the Phase II study with Yeliva™ for the treatment of hepatocellular carcinoma . The study will be supported by additional funding from RedHill.
The Phase II study will evaluate Yeliva™ as a second-line monotherapy in up to 39 patients with advanced hepatocellular carcinoma who have experienced tumor progression following treatment with firstline single-agent sorafenib (Nexavar®).
