Longeveron Announces Activation of Two New Clinical Sites in ELPIS II Trial of Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)
October 20 2021 - 08:30AM
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.
Investor Contact:
Brendan PayneStern Investor RelationsOffice
Direct: 212-698-8695 |Office Main:
212-362-1200brendan.payne@sternir.com | www.sternir.com
Source: Longeveron IncSource: LGVN
Longeveron (NASDAQ:LGVN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Longeveron (NASDAQ:LGVN)
Historical Stock Chart
From Mar 2023 to Mar 2024