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.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology
company developing cellular therapies for specific aging-related
and life-threatening conditions. The Company’s lead investigational
product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”),
which is derived from culture-expanded medicinal signaling cells
(MSCs) that are sourced from bone marrow of young, healthy adult
donors. Longeveron believes that by using the same cells that
promote tissue repair, organ maintenance, and immune system
function, it can develop safe and effective therapies for some of
the most difficult disorders associated with the aging process and
other medical disorders. Longeveron is currently sponsoring Phase 1
and 2 clinical trials in the following indications: Aging Frailty,
Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory
Distress Syndrome (ARDS), and hypoplastic left heart syndrome
(HLHS). The Company’s mission is to advance Lomecel-B and other
cell-based product candidates into pivotal Phase 3 trials, with the
goal of achieving regulatory approvals, subsequent
commercialization, and broad use by the healthcare community.
Additional information about the Company is available at
www.longeveron.com.
Forward-Looking and Other
Statements
Certain statements in this press release that
are not historical facts are forward-looking statements that
reflect management's current expectations, assumptions, and
estimates of future performance and economic conditions, and
involve risks and uncertainties that could cause actual results to
differ materially from those anticipated by the statements made
herein. Forward-looking statements are generally identifiable by
the use of forward-looking terminology such as "believe,"
"expects," "may," "looks to," "will," "should," "plan," "intend,"
"on condition," "target," "see," "potential," "estimates,"
"preliminary," or "anticipates" or the negative thereof or
comparable terminology, or by discussion of strategy or goals or
other future events, circumstances, or effects. Moreover,
forward-looking statements in this release include, but are not
limited to, statements about the ability of our clinical trials to
demonstrate safety and efficacy of our product candidates, and
other positive results, including achievement of primary endpoints;
the timing and focus of our ongoing and future preclinical studies
and clinical trials; the size of the market opportunity for our
product candidates, the beneficial characteristics, safety,
efficacy and therapeutic effects of our product candidates; our
ability to obtain and maintain regulatory approval of our product
candidates, our plans and ability to obtain or protect intellectual
property rights, including extensions of existing patent terms
where available and our ability to avoid infringing the
intellectual property rights of others. Further information
relating to factors that may impact the Company's results and
forward-looking statements are disclosed in the Company's filings
with the SEC. The forward-looking statements contained in this
press release are made as of the date of this press release, and
the Company disclaims any intention or obligation, other than
imposed by law, to update or revise any forward-looking statements,
whether as a result of new information, future events, or
otherwise.
Contact:Brendan PayneStern Investor
RelationsTel: (212) 362-1200Email: Brendan.payne@sternir.com
Source: Longeveron IncSource: LGVN
Source: Longeveron
Longeveron (NASDAQ:LGVN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Longeveron (NASDAQ:LGVN)
Historical Stock Chart
From Mar 2023 to Mar 2024