Multicenter, double-blinded, controlled study
designed to evaluate safety & efficacy of Lomecel-B intramyocardial
injection in infants with HLHS
• Funded
by the National Heart, Lung and Blood Institute (Grant number
1UG3HL148318 and 1U24HL148316) in collaboration with Longeveron
MIAMI,
July 06, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN)
("Longeveron" or "Company"), a clinical stage biotechnology company
developing cellular therapies for chronic aging-related and
life-threatening conditions, announced today that the first patient has
been enrolled and treated in the Phase 2b clinical study evaluating
Lomecel-B intraventricular injection in infants with Hypoplastic Left
Heart Syndrome (HLHS). Lomecel-B is an investigational allogeneic, bone
marrow-derived medicinal signaling cell (MSC) product manufactured in
Longeveron’s cell processing facility in Miami, Florida.
Longeveron’ s HLHS program has transitioned to Phase 2, with a randomized, double-blind, controlled trial titled: Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPIS II).
The trial is being funded by a grant from the National Institute of
Health’s National Heart, Lung and Blood Institute (NHLBI), in
collaboration with Longeveron, and is led by Principal Investigator,
Sunjay Kaushal, MD, PhD, Division Head Cardiovascular Thoracic Surgery,
Ann and Robert H. Lurie Children’s Hospital of Chicago. With a target
enrollment of 38 infants, the trial will be enrolling in 7 children’s
hospitals in major metropolitan centers located throughout the U.S. For
more information regarding the trial design and location of clinical
sites please visit www.elpistrial.org hosted by the University of Texas Health Sciences Center which serves as the data coordinating center.
“After
demonstrating safety and feasibility in the successfully completed
Phase 1 ELPIS trial, we are now embarking upon the next phase of
development, which importantly includes a control arm for comparison
against babies treated with Lomecel-B injection,” remarked Dr. Kaushal.
“Our hypothesis is that transplanted Lomecel-B medicinal signaling cells
into the right ventricle as an adjunct to HLHS surgery will improve
right ventricle structure and performance compared with surgery alone,
potentially leading to a clinical benefit. We feel that this trial is a
crucial step forward for developing cell-based therapy as an adjunct for
surgery in HLHS.”
About Hypoplastic Left Heart Syndrome
HLHS
is a rare congenital heart defect that effects approximately 1,000
babies per year in the U.S. Babies with HLHS are born with an
underdeveloped left ventricle, which creates a life-threatening
condition due to the heart’s inability to pump adequate amounts of blood
throughout the body. Children must undergo a complex three-staged
reconstructive surgery. Even with the advent of surgical intervention,
babies with the condition still have a high rate of needing heart
transplant, and is associated with high mortality. In the Phase 1 trial,
the primary safety endpoint was met, with no major adverse cardiac
events reported. The cell injections also did not cause infections
attributable to the study product. Additional clinical safety and
efficacy results from the Phase 1 trial are currently being analyzed.
In
HLHS patients, the right ventricle is subject to chronic pressure
overload due to the lack of left ventricle, and thus becomes
dysfunctional, leading to heart failure. It is believed that the primary
therapeutic benefit of MSCs comes from the secretion of bioactive
molecules that promote neovascularization, favorable remodeling, and
activation of endogenous stem cells and cardiomyocytes, ultimately
leading to improvement in overall structure, function, and durability.
The goal of Lomecel-B injection is reduced myocardial fibrosis,
increased angiogenesis, and increased cardiomyocyte and endothelial cell
proliferation.
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; 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.
Research
referred to in this press release is being supported by the National
Heart, Lung, And Blood Institute of the National Institutes of Health
under Award Number UG3HL148318. The content is solely the responsibility
of the authors and does not necessarily represent the official views of
the National Institutes of Health.
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)
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