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 publication of the design and rationale from its
recently completed Phase 2b aging frailty clinical trial with
Lomecel-B in the Journal of Frailty and Aging. This peer-reviewed
article describes the design of the trial which investigated
Lomecel-B, a living cell therapy product, as a regenerative
medicine strategy for the treatment of frailty in older adults.
As a life-threatening geriatric condition, aging
frailty affects up to 15% of Americans over the age of 65, or 8.1
million individuals, and manifests as a loss of muscle and
decreased strength, slowed walking, low activity and energy levels,
poor endurance, nutritional deficiencies, weight loss and
fatigue.
“There is increasing recognition of the unmet
medical need in treating and preventing frailty in older adults,
and we feel the acceptance of our trial design and rationale for
publication in this prestigious, peer-reviewed journal reflects the
urgency to develop potential new therapies,” said Geoff Green, CEO
of Longeveron.
The publication by Longeveron Senior Scientist
Dr. Anthony Oliva and colleagues is titled “The Design and
Rationale of a Phase 2b, Randomized, Double-Blinded, and
Placebo-Controlled Trial to Evaluate the Safety and Efficacy of
Lomecel-B in Older Adults with Frailty,” and is accessible here
(https://link.springer.com/article/10.14283/jfa.2022.2) This trial
was designed and conducted in partnership with the National
Institute on Aging. The results of the trial were previously
announced by the Company on August 13th, 2021.
About Aging Frailty
Aging Frailty is a life-threatening geriatric
condition, which studies have estimated affect approximately 15% of
Americans over the age of 65, or 8.1 million individuals. Aging
Frailty patients are vulnerable to poor clinical outcomes compared
to their age-matched peers despite sharing similar comorbidities
and demographics, and therefore it is considered an extreme form of
unsuccessful aging. Clinically, frailty manifests as a combination
of symptoms that includes loss of muscle and decreased strength,
slowed walking, low activity and energy levels, poor endurance,
nutritional deficiencies, weight loss and fatigue. Aging Frailty is
also associated with chronic low-level sterile inflammation.
Individuals with Aging Frailty have decreased reserves and a
reduced ability to cope with minor illnesses or stressors that
would normally have minimal impact, such as an infection or a fall.
As a result, the individual may be more likely to be hospitalized,
need long term care, or die. Inflammation can contribute to the
physical decline in Aging Frailty through multiple mechanisms,
including detrimental effects on muscles, bone tissue, the immune
system, cardiovascular function, and cognition.
The necessity for identifying patients with
Aging Frailty is well-acknowledged in the geriatric community, and
the treatment of Aging Frailty and promotion of healthful aging are
recognized priorities of the National Academy of Medicine and
NIA/NIH. Despite the pressing need for interventions, there are no
FDA-approved therapies that can slow down, reverse, or prevent
Aging Frailty.
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
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