MIAMI, Oct. 20, 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 the activation of two new
clinical sites for the currently enrolling ELPIS II Trial, evaluating
Lomecel-B injection into the myocardium of infants with Hypoplastic Left
Heart Syndrome (HLHS), a rare and life-threatening congenital heart
defect. Lomecel-B is an investigational allogeneic, bone marrow-derived
medicinal signaling cell (MSC) product manufactured in Longeveron’s cell
processing facility in Miami, Florida.
The two
newly activated clinical sites, which join the Ann and Robert H. Lurie
Children’s Hospital of Chicago (Principal Investigator Sunjay Kaushal,
M.D., Ph.D.) as open for enrollment, are:
Advocate Children’s Hospital
Principal Investigator: Narutoshi Hibino, M.D.
Primary Children’s Hospital/University of Utah, Salt Lake City, Utah
Principal Investigator: S. Adil Husain, M.D.
“We
are pleased with the progress that Dr. Kaushal and the University of
Texas Health Sciences Center are making in activating new clinical sites
for enrollment,” stated Longeveron CEO Geoff Green. “The addition of
these exceptional institutions, as well as future sites to be activated,
is important for both timely execution of the ELPIS II trial, as well
as for providing more options for families with children with HLHS to
participate in the research.”
About the ELPIS II Trial
The
HLHS program has transitioned into a Phase 2 trial titled: Evaluation
of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart
Syndrome: A Phase 2b Clinical Trial (ELPIS II). ELPIS II is being funded
by a grant from the National Institute of Health’s National Heart,
Lung, and Blood Institute (NHLBI; Grant number 1UG3HL148318), in
collaboration with Longeveron, and is led by Principal Investigator
Sunjay Kaushal, M.D., Ph.D., Division Head, Cardiovascular-Thoracic
Surgery, Ann and Robert H. Lurie Children’s Hospital of Chicago. With a
target enrollment of 38 infants, the trial began enrollment in July
2021, and it is anticipated that up to seven children’s hospitals will
be participating, all in major metropolitan centers located throughout
the U.S. For more information regarding the trial design and location of
clinical sites please visit clinicaltrials.gov (NCT04925024), and www.elpistrial.org hosted by the University of Texas Health Sciences Center which serves as the data coordinating center.
About the ELPIS I Trial
The
Phase I, open-label single arm study was designed to assess safety and
tolerability of intramyocardial injection of Lomecel-B administered to
10 infants with HLHS during Stage 2 bidirectional cavopulmonary
anastomosis (BDCPA, or “Glenn procedure”) surgeries. The study met its
primary endpoint, showing that intramyocardial injection of Lomecel-B at
2.5 × 106 cells/kg of body weight was well-tolerated, with
no major adverse cardiac events (MACE), and no infections reported that
were considered to be related to investigational treatment. The trial
was partially funded by a grant from the Maryland Stem Cell Research
Fund (MSCRF).
About Hypoplastic Left Heart Syndrome
HLHS
is a rare congenital heart defect that affects 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 are 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 potential improvement in cardiac structure,
function, and durability.
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.
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
