Cimaglermin Alfa Shows Promise in Phase I Heart Failure Trial
Cimaglermin was generally well-tolerated, except for nausea and headache.
HealthDay News – The recombinant growth factor, cimaglermin alfa, may enhance cardiac function in left ventricular systolic dysfunction (LVSD), according to a study published in JACC: Basic to Translational Science.
Daniel J. Lenihan, MD, from Vanderbilt University in Nashville, Tennessee, and colleagues examined the safety, tolerability, and exploratory efficacy of intravenous infusion of cimaglermin alfa in a first-in-human, phase 1 single ascending dose study involving 40 patients with heart failure and LVSD.
The researchers found that cimaglermin treatment was generally well tolerated in these patients on optimal guideline-directed medical therapy, except for transient nausea and headache. At the highest planned dose, dose-limiting toxicity was noted. A dose-dependent improvement was seen in left ventricular ejection fraction, which lasted 90 days after infusion.
"Thus, cimaglermin is a potential therapy to enhance cardiac function in LVSD and warrants further investigation," the authors wrote.
Disclosures: Several authors disclosed financial ties to pharmaceutical companies, including Acorda Therapeutics, which is developing cimaglermin alfa and funded the study.
- Lenihan DJ, Anderson SA, Lenneman CG, et al. A phase I, single ascending dose study of cimaglermin alfa (Neuregulin 1β3) in patients with systolic dysfunction and heart failure. JACC Basic Transl Sci. 2016;7(1). doi:10.1016/j.jacbts.2016.09.005.
- Bishopric NH. A growth tonic for heart failure? JACC Basic Transl Sci. 2016;7(1). doi:10.1016/j.jacbts.2016.11.002.