First-in-human trial shows cimaglermin generally well tolerated in left ventricular systolic dysfunction
WEDNESDAY, Dec. 28, 2016 (HealthDay News) — The recombinant growth factor, cimaglermin alfa, may enhance cardiac function in left ventricular systolic dysfunction (LVSD), according to a study published in the Dec. 1 issue of JACC: Basic to Translational Science.
Daniel J. Lenihan, M.D., from Vanderbilt University in Nashville, Tenn., 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 write.
Several authors disclosed financial ties to pharmaceutical companies, including Acorda Therapeutics, which is developing cimaglermin alfa and funded the study.
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