Longeveron LLC, a biopharmaceutical company that develops stem cell therapies for aging-related diseases, announced that the International Conference on Frailty & Sarcopenia Research (ICSFR) Task Force has published a key paper on Aging Frailty, a worldwide public health priority that is increasing in severity as human populations age. The paper entitled "Designing Drug Trials for Frailty: ICSFR Task Force 2018," was published in JFA: The Journal of Frailty & Aging.
Longeveron is part of the ICSFR Task Force comprised of international Frailty and clinical trial experts from industry and academia that met earlier this year to address the need to accelerate development of treatments for Aging Frailty, in an attempt to promote consensus regarding clinical trial design to assess the efficacy of treatment in older populations. As noted in the publication, Aging Frailty is a major contributor to disability and loss of independence in late life, as well as poor health outcomes and increased costs.
"Older people who have frailty are in poorer health, have weaker immune systems and higher rates of inflammation that increase their susceptibility to serious medical conditions, such as heart disease. As lifespans lengthen, it is key to improve 'healthspans' – health and quality of life in the later stages of life," said Joshua M. Hare, M.D., Longeveron Co-Founder and Chief Science Officer.
"Frailty is a condition characterized by progressive functional decline and heightened vulnerability to stress from decreased physiological reserve and resilience in older adults. Complex genetic, physiologic and psychosocial processes contribute to the development of frailty. Both lifestyle and pharmacological approaches will likely be required for successful prevention and treatment," added Marco Pahor, M.D., Director of the University of Florida Institute on Aging and lead author of the paper. Longeveron is now recruiting for an expanded Phase 2b Aging Frailty study. Dr. Pahor is the lead investigator of that trial.
In 2017, Longeveron published first in man Phase I and Phase 2 clinical studies in the Journals of Gerontology that evaluated the safety and efficacy of its allogeneic Mesenchymal Stem Cells (MSCs) in patients with Aging Frailty. Frail patients showed clinically meaningful improvement in physical performance, lung function and inflammatory biomarkers, with no serious adverse effects attributed to the treatment. These clinical trial endpoints were discussed in the consensus document.
About Longeveron
Longeveron (www.longeveron.com) is a regenerative medicine therapy company founded in 2014. Longeveron's goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company's research focus areas Aging Frailty, the Metabolic Syndrome and Alzheimer's Disease and gratefully acknowledges the generous support of the National Institutes of Health, the Alzheimer's Association and Maryland Stem Cell Research Fund. Longeveron is also conducting a Phase 1 trial to study Hypoplastic Left Heart Syndrome, a rare indication that affects infants, supported through a grant from the Maryland Stem Cell Research Fund.
For more information about the clinical trials Longeveron is sponsoring, visit ClinicalTrials.gov or Longeveron's website www.longeveron.com
