A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure

Daniel J. Lenihan; Sarah A. Anderson; Carrie Geisberg Lenneman; Evan Brittain; James A.S. Muldowney; Lisa Mendes; Ping Z. Zhao; Jennifer Iaci; Stephen Frohwein; Ronald Zolty; Andrew Eisen; Douglas B. Sawyer; Anthony O. Caggiano

doi:10.1016/j.jacbts.2016.09.005

A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure

Daniel J. Lenihan, Sarah A. Anderson, Carrie Geisberg Lenneman, Evan Brittain, James A.S. Muldowney, Lisa Mendes, Ping Z. Zhao, Jennifer Iaci, Stephen Frohwein, Ronald Zolty, Andrew Eisen, Douglas B. Sawyer, Anthony O. Caggiano

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

44 Scopus citations

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.

Original language	English (US)
Pages (from-to)	576-586
Number of pages	11
Journal	JACC: Basic to Translational Science
Volume	1
Issue number	7
DOIs	https://doi.org/10.1016/j.jacbts.2016.09.005
State	Published - 2016

Keywords

cardiac repair
growth factor
neuregulin
systolic dysfunction

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jacbts.2016.09.005

Cite this

Lenihan, D. J., Anderson, S. A., Lenneman, C. G., Brittain, E., Muldowney, J. A. S., Mendes, L., Zhao, P. Z., Iaci, J., Frohwein, S., Zolty, R., Eisen, A., Sawyer, D. B., & Caggiano, A. O. (2016). A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure. JACC: Basic to Translational Science, 1(7), 576-586. https://doi.org/10.1016/j.jacbts.2016.09.005

Lenihan, DJ, Anderson, SA, Lenneman, CG, Brittain, E, Muldowney, JAS, Mendes, L, Zhao, PZ, Iaci, J, Frohwein, S, Zolty, R, Eisen, A, Sawyer, DB & Caggiano, AO 2016, 'A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure', JACC: Basic to Translational Science, vol. 1, no. 7, pp. 576-586. https://doi.org/10.1016/j.jacbts.2016.09.005

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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.",

keywords = "cardiac repair, growth factor, neuregulin, systolic dysfunction",

author = "Lenihan, {Daniel J.} and Anderson, {Sarah A.} and Lenneman, {Carrie Geisberg} and Evan Brittain and Muldowney, {James A.S.} and Lisa Mendes and Zhao, {Ping Z.} and Jennifer Iaci and Stephen Frohwein and Ronald Zolty and Andrew Eisen and Sawyer, {Douglas B.} and Caggiano, {Anthony O.}",

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