Longeveron Announces Dr. Jorge Ruiz as Speaker for Roundtable Discussion & Presentation at 2021 International Conference for Frailty & Sarcopenia Research
September 21 2021 - 8:00AM
Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or
"Company"), a clinical stage biotechnology company developing
cellular therapies for chronic aging-related and life-threatening
conditions, today announced that Jorge Ruiz, M.D., Associate
Director for Clinical Affairs at the Geriatric Research, Education
and Clinical Center (GRECC), Miami Veterans Affairs Healthcare
System, and lead investigator in the trial, will present the
results from the trial titled: A Phase 2b, Randomized, Blinded and
Placebo-Controlled Trial to Evaluate the Safety and Efficacy
of Lomecel-B Infusion in Patients With Aging Frailty (the
“Phase 2b trial”) at the 2021 11th Annual International Conference
for Frailty & Sarcopenia (ICFSR).
The trial and results, previously announced by
the Company on August 13, 2021, will be presented via a
pre-recorded webcast by Dr. Ruiz during a Roundtable on September
29, 2021, which will be followed by a live question and answer
session from registered conference attendees. The webcast and
recording of the Roundtable will be accessible on the “Events &
Presentations” page on the Longeveron website at
https://investors.longeveron.com/events-and-presentations/default.aspx
after the conference, which runs from September 29 to October 1,
2021.
About the Phase 2b Trial
The Phase 2b trial, which was partially funded
by a Small Business Innovation Research (SBIR) grant from the
National Institute on Aging (NIA), evaluated the safety and
efficacy of a single peripheral intravenous infusion of four
different doses of Lomecel-B cell therapy (25 million (n=37), 50
million (n=31), 100 million (n=34) and 200 million (n=16) cells).
The primary objective of the study was to assess the effect of
Lomecel-B treatment on exercise tolerance and endurance via the
six-minute walk test (6MWT).
- Results showed that frail subjects
(average age of 75.2 years) with impaired mobility could walk
nearly 50 meters further 180 days after a single infusion of
Lomecel-B (200 million Lomecel-B group; p=0.0065). This increase
persisted through 270 days (200 million Lomecel-B group change from
baseline 47.9 meters; p=0.0115, and p=0.0077 compared to placebo).
By comparison, the placebo-treated subjects change from baseline at
180 days and 270 days was 8.0 meters (p=0.5371) and -15.5 meters
(p=0.2728), respectively. Additionally, results showed a clear,
statistically significant dose-response curve at day 180 using the
6MWT endpoint.
About Aging Frailty
Aging Frailty is a life-threatening geriatric
condition affecting approximately 15% of Americans over the age of
65, or 8.1 million individuals. Aging Frailty patients are
vulnerable to poor clinical outcomes compared to their age-matched
peers despite sharing similar comorbidities and demographics, and
therefore it is considered an extreme form of unsuccessful aging.
Clinically, frailty manifests as a combination of symptoms that
includes loss of muscle and decreased strength, slowed walking, low
activity and energy levels, poor endurance, nutritional
deficiencies, weight loss and fatigue. Aging Frailty is also
associated with chronic low-level sterile inflammation. Individuals
with Aging Frailty have decreased reserves and a reduced ability to
cope with minor illnesses or stressors that would normally have
minimal impact, such as an infection or a fall. As a result, the
individual may be more likely to be hospitalized, need long term
care, or die. Inflammation can contribute to the physical decline
in Aging Frailty through multiple mechanisms, including detrimental
effects on muscles, bone tissue, the immune system, cardiovascular
function, and cognition.
The necessity for identifying patients with
Aging Frailty is well-acknowledged in the geriatric community, and
the treatment of Aging Frailty and promotion of healthful aging are
recognized priorities of the National Academy of Medicine and
NIA/NIH. Despite the pressing need for interventions, there are no
FDA-approved therapies that can slow down, reverse, or prevent
Aging Frailty.
About Lomecel-B
Lomecel-B is a proprietary allogeneic product
comprised of medicinal signaling cells (MSCs) from the bone marrow
of adult donors and culture-expanded in Longeveron’s current good
manufacturing practice (cGMP) cell processing facility.
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
https://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.
Investor Contact:
Brendan PayneStern Investor
Relations212-698-8695brendan.payne@sternir.com
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