MIAMI, Jan. 05, 2022 (GLOBE 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.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
Print Page
Email to a Friend
