Longeveron Enters into Cooperative
Research and Development Agreement with the US Department of
Veterans Affairs for its Phase 2 Alzheimer's Trial
This third collaboration with the
Miami VA shows Longeveron's commitment to improving the health of
our nation's Veterans.
Miami, Florida -
April 13, 2022 -- InvestorsHub 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 a Cooperative Research and Development Agreement
(CRADA) with the United States Department of Veterans Affairs (VA)
for the addition of a Miami VA clinical site to its ongoing
Phase 2
Alzheimer's Disease (AD) trial.
As recently reported in a peer
reviewed article in Alzheimer's &
Dementia,® The Journal of
the Alzheimer's
Association, Longeveron's
Phase 1 trial met its primary endpoint, demonstrating that its drug
Lomecel-B was well tolerated in Alzheimer's patient. In addition,
the data provided indications supporting further exploration of
Lomecel-B, particularly the therapeutic potential to slow cognitive
decline and improve quality of life in patients with AD.
"After meeting the rigorous requirements of the VA, we are
pleased to announce the addition of this particular Miami VA site
to our ongoing trial," said Geoff Green, Chief Executive Officer at
Longeveron. "This continued collaboration between Longeveron and
the Miami VA reflects our ongoing dedication to finding a cure for
this severe disease in the vital setting of the VA health
system."
This marks the third separate CRADA agreement between the VA
and Longeveron, including an Aging Frailty study and an ongoing
study on Covid-19, further cementing the strong partnership and
focus on the Veteran population. The VA Miami Healthcare System
provides primary and specialty health care services to
approximately 63,000 Veterans in three south Florida counties -
Miami-Dade, Broward and Monroe. The lead trial investigator at the Miami
VA is Dr. Jorge G. Ruiz, the Associate Director of the VA's
Department of Geriatric Research Education and Clinical Center
(GRECC).
"The Miami VA Healthcare
System GRECC is, once again, pleased to be partnering with
Longeveron on another important study," Dr. Ruiz stated. "We share
the goal of caring for our Veteran's with Alzheimer's disease,
which is affecting many older Veterans and the overall older
population," he added.
The CLEAR MIND Trial, a Phase 2a study, 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 four 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.
Contact:
Brendan Payne
Stern Investor Relations
Tel: (212) 362-1200
Email: Brendan.payne@sternir.com
Source: Longeveron