According to a recent study, Cimaglermin, a novel experimental drug, can be helpful in restoring cardiac function after heart failure.
Heart failure, due to the loss of cardiac function, is one of the major causes of death across the globe. A significant portion of heart failure patients, particularly those with severe left ventricular systolic dysfunction, do not sufficiently respond to current medical therapy.
Efficiency of cimaglermin
Researchers evaluated the safety and efficiency of a single combination of cimaglermin, which plays the role of a growth factor for the heart, facilitating the structural, metabolic and contractile elements of the heart to repair itself after the injury. The study was conducted among 40 heart failure patients who were undergoing best medical therapy for at least three months earlier to the trial. When compared with patients who received a placebo, patients who given a high dose of cimaglermin had a prolonged increase in left ventricular ejection fraction, or pumping capacity, through 90 days after dosage, with the highest increase reached at day 28.
“These results support continued clinical development of the experimental drug cimaglermin, including further safety assessments and detailing the potential advancement on clinical heart failure outcome measures,” mentioned Daniel J. Lenihan MD, the lead author of the study who works with the division of cardiovascular medicine at Vanderbilt University. “Along with all investigational therapeutics, further studies will be needed and are subject to regulatory review to conclude if the relative risks and benefits of cimaglermin confirm approval.”
The most general side effects were headache and nausea, which were, in the short term, related to drug exposure. One patient who received the maximum planned dosage of cimaglermin had an adverse reaction that met the stopping criteria of Federal Drug Administration guidance for drug induced liver injury.
Limitations of this study include the smaller sample size and that the patients only received a single dose rather than multiple infusions.
“Even though the results of the study must be considered as provisional because of the small numbers of patients, the results of this study are however very exciting,” noted Douglas L. Mann, MD, FACC, editor-in-chief of JACC: Basic to Translational Science. “Rather than blocking the basic mechanisms that lead to cardiac injury, the early results with cimaglermin propose that it can also be possible to administer therapeutics that permit the failing heart to repair itself with the help of its own repair mechanisms. If the findings of this study can be replicated and translated into advancements in clinical results in larger numbers of patients in phase II and III clinical trials, it will symbolize a paradigm shift in the way in which clinicians treat patients with heart failure.”
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