Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a
clinical stage biotechnology company developing regenerative
medicines for unmet medical needs, today announced that the first
patient has been treated with Lomecel-B™ in its Phase 2
clinical trial in patients with Aging-Related Frailty in Japan. The
trial aims to enroll 45 patients and its primary objective is to
evaluate safety.
“We are excited to announce the dosing of the
first patient in our Japanese Aging-Related Frailty trial,” said
Wa’el Hashad, Longeveron’s Chief Executive Officer. “In 2022,
Longeveron aligned with the Japan Pharmaceuticals and Medical
Devices Agency (PMDA), on the Phase 2 trial design and we hope the
data from this trial will provide support for a limited approval
under Japan’s Act on the Safety of Regenerative Medicine (ASRM),
which allows regenerative medicine products to be administered to
patients by approved hospitals or clinics under the practice of
medicine. This is the first use of our U.S.-manufactured product in
Japan, and we look forward to advancing Lomecel-B™ as a treatment
for Aging-Related Frailty in Japan.”
Hidenori Arai, M.D., Ph.D., President of the
National Center for Geriatrics and Gerontology, and principal
investigator of the Phase 2 trial, commented, “I am pleased to see
this clinical trial program advancing, especially given the large
unmet need in Japan, where nearly 30% of the population is over the
age of 65. I was encouraged by Longeveron’s previously announced
Phase 2b Aging-Related Frailty study in the United States, where
subjects receiving a single infusion of Lomecel-B™ showed a
statistically significant and clinically meaningful improvement in
walking distance at 9 months post-infusion compared to placebo. I
look forward to building on that data in the Japanese
population.”
The Phase 2 clinical trial is a 3-arm, parallel
design, randomized (1:1:1), placebo-controlled, double-blind single
infusion study of two different dose levels of Lomecel-B™. The
trial is expected to enroll 45 patients and has a primary objective
of evaluating safety of Lomecel-B™ as a treatment for
Aging-Related Frailty. The trial is being conducted in partnership
with the National Center for Geriatrics & Gerontology
(NCGG;Nagoya) and Juntendo University Hospital (Tokyo).
Japan is considered to be a “super-aged” society
with some 36.4 million individuals aged 65 or older in 2021,
representing 29.1% of the population. The overall prevalence of
aging-related frailty amongst this demographic is estimated to be
7.9%.
About Aging-Related Frailty
Aging-Related Frailty is an age-associated
decline in reserve and function across multiple physiologic systems
leading to the inability to cope with stressors. It is
characterized by mobility impairment, weakness, fatigue, weight
loss, slowness, and low activity and puts individuals at higher
risk for poor clinical outcomes, such as infections, falls,
fractures, hospitalization, or death.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology
company developing regenerative medicines to address unmet medical
needs. The Company’s lead investigational product is Lomecel-B™, an
allogeneic medicinal signaling cell (MSC) therapy product isolated
from the bone marrow of young, healthy adult donors. Lomecel-B™ has
multiple potential mechanisms of action encompassing pro-vascular,
pro-regenerative, anti-inflammatory, and tissue repair and healing
effects with broad potential applications across a spectrum of
disease areas. Longeveron is currently advancing Lomecel-B™ through
clinical trials in three indications: hypoplastic left heart
syndrome (HLHS), Alzheimer’s Disease, and Aging-Related Frailty.
Additional information about the Company is available at
www.longeveron.com.
About the Act on the Safety of
Regenerative Medicine (ASRM)
The ASRM was passed in 2014 in order to provide
incentives and accelerated approval pathways for regenerative
medicine products in Japan. The act provides pathways for both
conditional approval and limited use of products under the practice
of medicine.
Forward-Looking Statements
Certain statements in this press release that
are not historical facts are forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, which reflect management's current
expectations, assumptions, and estimates of future operations,
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. Factors that could cause actual results
to differ materially from those expressed or implied in any
forward-looking statements in this release include, but are not
limited to, statements about the ability of Longeveron’s clinical
trials to demonstrate safety and efficacy of the Company’s product
candidates, and other positive results; the timing and focus of the
Company’s ongoing and future preclinical studies and clinical
trials and the reporting of data from those studies and trials; the
size of the market opportunity for the Company’s product
candidates, including its estimates of the number of patients who
suffer from the diseases being targeted; the success of competing
therapies that are or may become available; the beneficial
characteristics, safety, efficacy and therapeutic effects of the
Company’s product candidates; the Company’s ability to obtain and
maintain regulatory approval of its product candidates; the
Company’s plans relating to the further development of its product
candidates, including additional disease states or indications it
may pursue; existing regulations and regulatory developments in the
U.S., Japan and other jurisdictions; the Company’s plans and
ability to obtain or protect intellectual property rights,
including extensions of existing patent terms where available and
its ability to avoid infringing the intellectual property rights of
others; the need to hire additional personnel and the Company’s
ability to attract and retain such personnel; the Company’s
estimates regarding expenses, future revenue, capital requirements
and needs for additional financing; the Company’s need to raise
additional capital, and the difficulties it may face in obtaining
access to capital, and the dilutive impact it may have on its
investors; the Company’s financial performance, and the period over
which it estimates its existing cash and cash equivalents will be
sufficient to fund its future operating expenses and capital
expenditures requirements. 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
Securities and Exchange Commission, including Longeveron’s Annual
Report on Form 10-K for the year ended December 31, 2021, filed
with the SEC on March 11, 2022, and the Company’s Quarterly Reports
on Form 10-Q. 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.
Investor Contact:
Stern IR, Inc.212-698-8700
longeveron@sternir.com
Source: Longeveron Inc
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