A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure.
Document Type
Article
Publication Date
12-1-2016
Institution/Department
Cardiology
Journal Title
JACC Basic Transl Sci
MeSH Headings
Humans, cimaglermin, heregulin alpha, Neuregulin-1, Heart Failure, Cardiomyopathies
Abstract
A first-in-human, phase 1, double blind, placebo-controlled, single ascending dose study examined the safety, tolerability, and exploratory efficacy of intravenous infusion of a recombinant growth factor, cimaglermin alfa, in patients with heart failure and left ventricular systolic dysfunction (LVSD). In these patients on optimal guideline-directed medical therapy, cimaglermin treatment was generally tolerated except for transient nausea and headache and a dose-limiting toxicity was noted at the highest planned dose. There was a dose-dependent improvement in left ventricular ejection fraction lasting 90 days following infusion. Thus, cimaglermin is a potential therapy to enhance cardiac function in LVSD and warrants further investigation.
ISSN
2452-302X
First Page
576
Last Page
586
Recommended Citation
Lenihan, Daniel J; Anderson, Sarah A; Lenneman, Carrie Geisberg; Brittain, Evan; Muldowney, James A S; Mendes, Lisa; Zhao, Ping Z; Iaci, Jennifer; Frohwein, Stephen; Zolty, Ronald; Eisen, Andrew; Sawyer, Douglas B; and Caggiano, Anthony O, "A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure." (2016). MaineHealth Maine Medical Center. 1503.
https://knowledgeconnection.mainehealth.org/mmc/1503