Benzinga | Nov 30, 2021 05:02PM EST

EXCLUSIVE: Longeveron Reports Co. Entered Into Sponsored Clinical Research Deal With Japan's National Center For Geriatrics And Gerontology, Juntendo University Hospital To Explore Safety, Efficacy Of Lomecel-B In Older Subjects

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 Japanese

subjects as well."



The Japanese Phase 2 study is a randomized, double-blind, placebo-controlled

design approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

The study has a target enrollment of 45 subjects and three cohorts, 15 per cohort,

randomized to receive a single intravenous infusion of Lomecel-B 50 million cells,

Lomecel-B 100 million cells, or placebo. The primary objective is to evaluate safety,

and explore the effect Lomecel-B on physical function, activities of daily living,

inflammation-related biomarkers (e.g. cytokines) in the blood, and other endpoints.

In addition to enrolling subjects at NCGG, Juntendo University Hospital in Tokyo and

Koto city are participating sites. Juntendo University Hospital was established in

1838 as the first medical school in Japan to adopt western medicine and is one of

Japan's largest private hospital chains. Juntendo University Hospital in Tokyo will

serve as the clinical coordinating center along with its sister campus in Koto City,

the Juntendo Koto Geriatric Medical Center.

References:

[1] Kojima, et al. Prevalence of frailty in Japan: A systematic review and meta-

analysis. Journal of Epidemiology, 27 (2017) 347 -353