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Longeveron Announces Phase 2 Clinical Trial in Japan to Test Safety and Efficacy of Lomecel-B on Aging Frailty Patients
New trial is in collaboration with Japan’s National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital MIAMI, Nov. 30, 2021 (GLOBE
About this update from Longeveron Inc.
[{"type":"text","content":"New trial is in collaboration with Japan’s National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital\nMIAMI, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or the \"Company\"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today that it has entered into a sponsored clinical research agreement with the National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital in Japan, to explore the safety and efficacy of Lomecel-B in older, frail Japanese subjects. “We are excited to embark on this collaboration with the NCGG, one of the top advanced and specialized medical research centers in Japan, and Juntendo University Hospital,” said Geoff Green, Chief Executive Officer at Longeveron. “We believe our work could be especially impactful in Japan, which has one of the oldest and fastest aging populations in the world, and where early identification and intervention of frailty is a priority,” continued Mr. Green. Japan is considered to be a “super-aged” society, with approximately 29.1% of the population aged 65 or older in 2021, representing some 36.4 million individuals. The overall prevalence of frailty amongst this demographic is estimated to be 7.9% [1] Lomecel-B has been evaluated in Phase 1 & 2 aging frailty clinical studies in the U.S. In addition, the U.S. Food and Drug Administration recently granted rare pediatric disease designation for Lomecel-B to treat Hypoplastic Left Heart Syndrome (HLHS), a life-threatening heart condition in infants. A Phase 2 clinical trial is currently underway in babies with HLHS. The President of the NCGG, Hidenori Arai, M.D., Ph.D., stated “We look forward to collaborating with Longeveron and Juntendo University Hospital to advance this very important clinical study. NCGG’s mission is to improve independence and longevity in older people through the promotion of physical and mental health. Based on the results of Longeveron’s previously announced U.S. Phase 2b trial for aging frailty, where subjects receiving a single infusion of Lomecel-B showed a statistically significant improvement in walking distance at day 270 post infusion compared to placebo, we are hopeful that we see improvements in physical function in ...