Longeveron
publishes Peer Reviewed Study of Phase 1 Trial Results of Lomecel-B
for Alzheimer's Disease in Alzheimer's & Dementia©: The Journal
of the Alzheimer's Association
Results Support Further Exploration
of Therapeutic Potential of Lomecel-B to Slow Cognitive Decline,
Improve Quality of Life for Alzheimer's Patients.
Phase 2 Trial Recently Launched with
First Patient Treated.
Miami– March 31, 2022 -
InvestorsHub NewsWire -- Longeveron Inc.
(NASDAQ: LGVN), a clinical-stage biopharma company
developing cellular therapies for aging-related illnesses, chronic
disorders, and other specific life-threatening conditions,
announced the publication of results from a Phase 1 trial testing
Lomecel-B on patients with mild Alzheimer's disease (AD) in
Alzheimer's & Dementia®
: The Journal of the Alzheimer's Association. The trial met
its primary endpoint, demonstrating that Lomecel-B was well
tolerated in this patient population. In addition, the data
provided indications supporting further exploration of Lomecel-B,
particularly the therapeutic potential to slow cognitive decline
and improve quality of life in patients with AD.
"We are pleased and encouraged by the publication of our
study in this high-impact journal," said Geoff Green, CEO of
Longeveron. "The Lomecel-B study was funded by two competitive Part
the Cloud Neuroinflammation Challenge grants awarded
to Longeveron from the Alzheimer's Association, for which we are
extremely grateful."
The article, titled "Results and Insights from a Phase 1
Clinical Trial of Lomecel-B for Alzheimer's disease," details the
study findings on Longeveron's lead investigational product,
Lomecel-B, an allogeneic bone marrow-derived medicinal signaling
cell (MSC) product, given to patients with mild Alzheimer's
disease.
"What makes this study unique is the use of a cellular
therapy that may potentially target multiple pathological features
of Alzheimer's disease simultaneously," said Dr. Mark Brody, lead
author of the manuscript. "Not only did the study meet its primary
endpoint of safety, but it also suggests the potential that
Lomecel-B could have in treating patients with Alzheimer's
disease. We found data suggesting
that Lomecel-B could have effects ranging from increasing blood
vessel health to reducing inflammation, which could yield promising
results."
The double-blinded, randomized, placebo-controlled trial was
conducted on thirty-three patients at four clinical sites. Each
patient received a single intravenous infusion of low- or high-dose
Lomecel-B, or a placebo. The findings from this study
are being tested in a new larger Phase 2 study, which commenced in
December 2021, and has already treated the first patient and
continues to enroll others. The new trial is
double-blinded, randomized, and placebo-controlled, and is designed
to evaluate single versus multiple doses of Lomecel-B for mild
Alzheimer's disease.
The major findings of the Phase 1 study as reported in
Alzheimer's & Dementia
are as follows:
-
The primary endpoint -- safety --
was met. The Lomecel-B infusion was well-tolerated, and there were
no treatment-related safety concerns. Importantly, patients receiving Lomecel-B
were not reported to develop a serious side-effect called
amyloid-related imaging abnormalities (ARIA) as assessed by
magnetic resonance imaging (MRI). Other classes of Alzheimer's drugs being
tested have been reported to cause ARIA.
-
Other exploratory findings
included:
-
The Mini Mental State Exam
(MMSE), used to evaluate cognitive status, showed a slower decline
in the low-dose Lomecel-B group versus the placebo
group.
-
The Quality of Life in Alzheimer
Disease (QOL-AD), used to evaluate patient well-being, showed a
significantly higher (better) score in the low-dose Lomecel-B group
versus the placebo group at six months after the single
treatment.
-
Brain imaging by magnetic
resonance imaging (MRI) showed an increase in left hippocampus
volume three months after a Lomecel-B infusion in the high-dose
Lomecel-B arm versus placebo. The hippocampus is a brain region
critical for memory formation, which normally undergoes rapid
neuron formation known as neurogenesis. This process is damaged in
Alzheimer's disease, leading patients to have reductions in the
size of their hippocampus.
"We are encouraged by these results," said Dr. Anthony Oliva,
Senior Scientist at Longeveron, and principal investigator on the
grants. "With a single dose of Lomecel-B, we observed several lines
of preliminary evidence supporting multiple mechanisms of action of
Lomecel-B, and most importantly, the data supports the potential of
Lomecel-B as disease modifying for Alzheimer's."
The results of this study could have important implications
for combatting this devastating disease that is also taking a
significant toll on healthcare systems. According to a
recent report by
the Alzheimer's Association, an estimated 6.5 million Americans age
sixty-five and older are living
with dementia due to Alzheimer's disease. Seventy-three percent are
age seventy-five or older. Of the
total U.S. population, about 1in 9 people (11.3%) age sixty-five
and older has dementia due to Alzheimer's disease.
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, 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 http://www.longeveron.com/.
Forward-Looking
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
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of our product candidates, and other positive results; the timing
and focus of our ongoing and future preclinical studies and
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therapeutic effects of our product candidates; our need and ability
to raise additional capital to fund operations; our ability to
obtain and maintain regulatory approval of our product candidates,
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rights, including extensions of existing patent terms where
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Media Contacts:
Eric Kim
Senior Vice President
Office Direct: 212-805-3052
ekim@rubensteinpr.com
Brigit Hennaman
Vice President
Office Direct: 212-805-3005
bhennaman@rubensteinpr.com
Investor Contact:
Brendan Payne
Stern Investor Relations, Inc.
Office Direct: 212-698-8695 |Office Main:
212-362-1200
brendan.payne@sternir.com | www.sternir.com
Source: Longeveron Inc
Source: LGVN