Longeveron
Announces Initiation of Phase 2a Clinical Trial of Lomecel-B for
the Treatment of Alzheimer's Disease
Trial designed
to obtain safety and efficacy data of single and multiple dosing
regimen
Miami, Florida—January 5, 2021 --
InvestorsHub NewsWire -- 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 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 Payne
Stern Investor Relations
Tel: (212) 362-1200
Email:
Brendan.payne@sternir.com
Source: Longeveron Inc
Source: LGVN
Source: Longeveron