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

Research output: Contribution to journalArticle

17 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 languageEnglish
Pages (from-to)576-586
Number of pages11
JournalJACC: Basic to Translational Science
Volume1
Issue number7
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

Keywords

  • cardiac repair
  • growth factor
  • neuregulin
  • systolic dysfunction

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    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