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

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 (LVS...

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Main Authors:	Daniel J. Lenihan, MD, Sarah A. Anderson, ACNP, Carrie Geisberg Lenneman, MD, Evan Brittain, MD, MSCI, James A.S. Muldowney, III, MD, Lisa Mendes, MD, Ping Z. Zhao, PhD, Jennifer Iaci, MS, Stephen Frohwein, MD, Ronald Zolty, MD, PhD, Andrew Eisen, MD, PhD, Douglas B. Sawyer, MD, PhD, Anthony O. Caggiano, MD, PhD
Format:	Article
Language:	English
Published:	Elsevier 2016-12-01
Series:	JACC: Basic to Translational Science
Subjects:	cardiac repair growth factor neuregulin systolic dysfunction
Online Access:	http://www.sciencedirect.com/science/article/pii/S2452302X16301619

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spelling	doaj-1b06ca8dbecb4850b7f6c85e6a80bdc02020-11-25T00:22:31ZengElsevierJACC: Basic to Translational Science2452-302X2016-12-011757658610.1016/j.jacbts.2016.09.005A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart FailureDaniel J. Lenihan, MD0Sarah A. Anderson, ACNP1Carrie Geisberg Lenneman, MD2Evan Brittain, MD, MSCI3James A.S. Muldowney, III, MD4Lisa Mendes, MD5Ping Z. Zhao, PhD6Jennifer Iaci, MS7Stephen Frohwein, MD8Ronald Zolty, MD, PhD9Andrew Eisen, MD, PhD10Douglas B. Sawyer, MD, PhD11Anthony O. Caggiano, MD, PhD12Division of Cardiovascular Medicine, Vanderbilt University, Nashville, TennesseeDivision of Cardiovascular Medicine, Vanderbilt University, Nashville, TennesseeDivision of Cardiovascular Medicine, Vanderbilt University, Nashville, TennesseeDivision of Cardiovascular Medicine, Vanderbilt University, Nashville, TennesseeDivision of Cardiovascular Medicine, Vanderbilt University, Nashville, TennesseeDivision of Cardiovascular Medicine, Vanderbilt University, Nashville, TennesseeAcorda Therapeutics, Inc., Ardsley, New YorkAcorda Therapeutics, Inc., Ardsley, New YorkEmory Heart and Vascular Center at Emory Saint Joseph’s, Atlanta, GeorgiaUniversity of Nebraska Medical Center, Omaha, NebraskaAcorda Therapeutics, Inc., Ardsley, New YorkMaine Medical Center, Portland, MaineAcorda Therapeutics, Inc., Ardsley, New YorkA 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.http://www.sciencedirect.com/science/article/pii/S2452302X16301619cardiac repairgrowth factorneuregulinsystolic dysfunction
collection	DOAJ
language	English
format	Article
sources	DOAJ
author	Daniel J. Lenihan, MD Sarah A. Anderson, ACNP Carrie Geisberg Lenneman, MD Evan Brittain, MD, MSCI James A.S. Muldowney, III, MD Lisa Mendes, MD Ping Z. Zhao, PhD Jennifer Iaci, MS Stephen Frohwein, MD Ronald Zolty, MD, PhD Andrew Eisen, MD, PhD Douglas B. Sawyer, MD, PhD Anthony O. Caggiano, MD, PhD
spellingShingle	Daniel J. Lenihan, MD Sarah A. Anderson, ACNP Carrie Geisberg Lenneman, MD Evan Brittain, MD, MSCI James A.S. Muldowney, III, MD Lisa Mendes, MD Ping Z. Zhao, PhD Jennifer Iaci, MS Stephen Frohwein, MD Ronald Zolty, MD, PhD Andrew Eisen, MD, PhD Douglas B. Sawyer, MD, PhD Anthony O. Caggiano, MD, PhD 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 cardiac repair growth factor neuregulin systolic dysfunction
author_facet	Daniel J. Lenihan, MD Sarah A. Anderson, ACNP Carrie Geisberg Lenneman, MD Evan Brittain, MD, MSCI James A.S. Muldowney, III, MD Lisa Mendes, MD Ping Z. Zhao, PhD Jennifer Iaci, MS Stephen Frohwein, MD Ronald Zolty, MD, PhD Andrew Eisen, MD, PhD Douglas B. Sawyer, MD, PhD Anthony O. Caggiano, MD, PhD
author_sort	Daniel J. Lenihan, MD
title	A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure
title_short	A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure
title_full	A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure
title_fullStr	A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure
title_full_unstemmed	A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure
title_sort	phase i, single ascending dose study of cimaglermin alfa (neuregulin 1β3) in patients with systolic dysfunction and heart failure
publisher	Elsevier
series	JACC: Basic to Translational Science
issn	2452-302X
publishDate	2016-12-01
description	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.
topic	cardiac repair growth factor neuregulin systolic dysfunction
url	http://www.sciencedirect.com/science/article/pii/S2452302X16301619
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A Phase I, Single Ascending Dose Study of Cimaglermin Alfa (Neuregulin 1β3) in Patients With Systolic Dysfunction and Heart Failure

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