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
Daniel J LenihanAnthony O Caggiano

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.

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Citations

Feb 27, 2017·American Journal of Physiology. Heart and Circulatory Physiology·Sergey RyzhovDouglas B Sawyer
Jul 11, 2019·Journal of Molecular Neuroscience : MN·Jessica M NollByron D Ford
Aug 23, 2019·International Journal of Molecular Medicine·Wen KangXin Wang
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Sep 12, 2018·European Heart Journal·Ali VazirStephen Westaby
Apr 4, 2021·International Journal of Molecular Sciences·Victor CamberosMary Kearns-Jonker
May 14, 2021·Circulation Research·Virginia S HahnBonnie Ky
Apr 7, 2021·Cell Regeneration·Lixia ZhengJing-Wei Xiong

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Methods Mentioned

BETA
glycosylation

Clinical Trials Mentioned

NCT01258387
NCT01944683

Software Mentioned

SAS

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