Longeveron Announces Initiation of Phase 2a Clinical Trial of Lomecel-B for the Treatment of Alzheimer’s Disease
January 05 2022 - 8:00AM
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 the initiation of its Phase 2a clinical trial
evaluating Lomecel-B as a treatment for Alzheimer’s disease (AD).
The first patient has consented to participate in the trial and
patient screening has begun.
This Phase 2a study is intended to build on
encouraging preliminary Phase 1 data that were announced in 2021.
Additionally, the Phase 2a trial is designed to measure brain
anatomy using MRI, and include detailed assessments of the
inflammatory and vascular systems thought to contribute to the
worsening of AD. The study, which will be conducted at a minimum of
6 centers, is led by Mark L. Brody, MD, of Brain Matters Research,
Delray Beach, Florida.
“This is an important next step in the progress
of our Alzheimer’s disease clinical program,” said Geoff Green, CEO
of Longeveron. “We are pleased to have initiated this Phase 2a
trial, as this study is intended to build upon the Phase 1 results
and marks an important milestone in our efforts to explore the
therapeutic potential of Lomecel-B in AD,” Green added.
Dementia resulting from AD is associated with
vascular function decline and involves a pro-inflammatory state. In
Longeveron’s prior Phase 1 trial, Lomecel-B treatment met the
primary safety endpoint, with no safety concerns – including no
evidence of Alzheimer’s-related imaging abnormality, known as ARIA.
In addition, the levels of certain pro-vascular and
anti-inflammatory biomarkers increased in the Lomecel-B treated
subjects compared to placebo.
The Phase 2a trial is a double-blind,
randomized, placebo-controlled design investigating safety and
tolerability, as well as secondary endpoints that include cognitive
function and biomarkers, following single or multiple infusions of
Lomecel-B compared to placebo, in individuals with mild AD. The
study consists of 4 treatment arms of 12 patients each, for a total
target enrollment of 48 patients.
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
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"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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