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LIMR investigators confirm potential medicinal benefit of a drug excipient

March 22, 2019 Research News

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 Main Line Health’s 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
  • 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.

About Main Line Health

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health’s commitment—to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health’s core are four of the region’s most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region’s largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association’s #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

About Lankenau Institute for Medical Research

Lankenau Institute for Medical Research (LIMR) is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center and is part of Main Line Health. Founded in 1927, LIMR’s mission is to improve human health and well-being. Faculty and staff are devoted to advancing innovative new approaches to formidable medical challenges, including cancer, cardiovascular disease, gastrointestinal disorders and autoimmune diseases, such as diabetes and arthritis. LIMR’s principal investigators conduct basic, preclinical and translational research, using their findings to explore ways to improve disease detection, diagnosis, treatment and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians.