LIMR investigators confirm potential medicinal benefit of a drug excipient

High doses of a substance long used in pharmaceutical manufacturing and previously believed to be benign appears to hold therapeutic value as an anti-inflammatory agent and to treat several disorders, including skin cancer, according to a newly published study from investigators at the Lankenau Institute for Medical Research (LIMR) and their colleagues.

The researchers set out to address gaps in knowledge about administration of high doses of oral meglumine, an amino sugar derived from glucose and often used as an excipient in drug formulation. (The standard purpose of an excipient is to streamline the manufacture of a drug product and facilitate physiological absorption of the medication.) Studies done elsewhere had shown that high-dose oral meglumine had therapeutic benefits in metabolic syndrome, diabetes, obesity, hypertriglyceridemia, and fatty liver disease such as nonalcoholic steatohepatitis.

The LIMR team and their colleagues advanced those earlier studies by shedding light on the pharmacology and toxicology of meglumine administered at high doses, and they explored its medicinal potential. In preclinical studies, the investigators found that high-dose meglumine:

  • limited secretion of proinflammatory cytokines, suggesting its potential as an anti-inflammatory agent;
  • had no negative effect on the animals’ lifespan, so it was considered safe for administration; and
  • had no adverse effects on cardiac parameters.

Additionally, among animals administered a tumor-initiating agent, the meglumine-treated animals had fewer numbers of skin tumors than their non-meglumine-treated littermates, suggesting that the substance may suppress tumor growth.

“This study provided preclinical evidence of the safety and potential anti-tumor effects of high doses of meglumine, a substance that, until recently, we thought was inert or had no medicinal impact,” said Susan Gilmour, PhD, professor and deputy director of LIMR and one of the study’s principal investigators. “This study also strengthens the rationale for additional clinical study of meglumine as a safe and low-cost medicinal agent.”

LIMR investigators worked with colleagues from Dynamis Pharmaceuticals in Jenkintown, Pa., and Drexel University’s College of Medicine. LIMR principal investigators George Prendergast, PhD, Lisa Laury-Kleintop, PhD, and Melvin Reichman, PhD, also contributed to this study. Major funding for the study was provided by the Lankenau Medical Center Foundation and Main Line Health, and partial funding was provided by Dynamis Pharmaceuticals Inc.

 

 

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