Cimaglermin, a new experimental drug, may help restore cardiac function after heart failure.
Heart failure, characterized by a loss of cardiac function, is among the leading causes of death worldwide. A significant portion of heart failure patients, particularly those with severe left ventricular systolic dysfunction, do not sufficiently respond to current medical therapy.
Researchers examined the safety and efficacy of a single infusion of cimaglermin, which acts as a growth factor for the heart, helping the structural, metabolic and contractile elements of the heart to repair itself following injury. The study enrolled 40 heart failure patients who were taking optimal medical therapy for at least three months prior to the trial. Compared to patients who received a placebo, patients who received a high dose of cimaglermin had a sustained increase in left ventricular ejection fraction, or pumping capacity, through 90 days after dosing, with the maximum increase reached at day 28.
Daniel J. Lenihan MD, from the division of cardiovascular medicine says, "These findings support continued clinical development of the investigational drug cimaglermin, including further safety evaluations and detailing the potential improvement on clinical heart failure outcome measures."
The most common side effects were headache and nausea, which were temporarily associated with exposure to the drug. One patient receiving the highest planned dose of cimaglermin experienced an adverse reaction that met the stopping criteria of Federal Drug Administration guidance for drug induced liver injury.
Douglas L. Mann, MD, FACC, editor in chief of JACC says,"Although the results of the study must be regarded as provisional because of the small numbers of patients, the results of this study are nonetheless very exciting."