TY - JOUR
T1 - A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure
AU - Lenihan, Daniel J.
AU - Anderson, Sarah A.
AU - Lenneman, Carrie Geisberg
AU - Brittain, Evan
AU - Muldowney, James A.S.
AU - Mendes, Lisa
AU - Zhao, Ping Z.
AU - Iaci, Jennifer
AU - Frohwein, Stephen
AU - Zolty, Ronald
AU - Eisen, Andrew
AU - Sawyer, Douglas B.
AU - Caggiano, Anthony O.
N1 - Publisher Copyright:
© 2016 The Authors
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - cardiac repair
KW - growth factor
KW - neuregulin
KW - systolic dysfunction
UR - http://www.scopus.com/inward/record.url?scp=85016093855&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85016093855&partnerID=8YFLogxK
U2 - 10.1016/j.jacbts.2016.09.005
DO - 10.1016/j.jacbts.2016.09.005
M3 - Article
C2 - 30167542
AN - SCOPUS:85016093855
SN - 2452-302X
VL - 1
SP - 576
EP - 586
JO - JACC: Basic to Translational Science
JF - JACC: Basic to Translational Science
IS - 7
ER -