Refining Liver Safety Risk Assessment: Application of Mechanistic Modeling and Serum Biomarkers to Cimaglermin Alfa (GGF2) Clinical Trials

• Published in: Clinical pharmacology and therapeutics Vol. 102; no. 6; pp. 961 - 969
• Main Authors: Longo, DM, Generaux, GT, Howell, BA, Siler, SQ, Antoine, DJ, Button, D, Caggiano, A, Eisen, A, Iaci, J, Stanulis, R, Parry, T, Mosedale, M, Watkins, PB
• Format: Journal Article
• Language: English
• Published: United States 01.12.2017
• Subjects: Alanine Transaminase - blood; Apoptosis; Bilirubin - blood; Biomarkers - blood; Clinical Trials as Topic; Humans; Liver - drug effects; Liver - pathology; Models, Statistical; Neuregulin-1 - adverse effects; Recombinant Proteins - adverse effects; Risk Assessment - methods

Cimaglermin alfa (GGF2) is a recombinant human protein growth factor in development for heart failure. Phase I trials were suspended when two cimaglermin alfa‐treated subjects experienced concomitant elevations in serum aminotransferases and total bilirubin, meeting current US Food and Drug Administ...