Longeveron Selects Clinical Research Organization for Phase 2 Alzheimer’s Disease Trial
November 05 2021 - 8:30AM
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 the selection of Biorasi LLC (“Biorasi”) as its clinical
research organization (CRO) to help conduct its Phase 2 clinical
trial evaluating Lomecel-B infusion in Alzheimer’s Disease (AD)
subjects.
Biorasi has extensive experience in the
management and execution of neurology clinical studies, with deep
experience in phase I through IV trials, both in the US and
globally.
“Partnering with Biorasi for Longeveron’s next
Phase 2 AD trial will help continue to advance the development of
Lomecel-B for the treatment of Alzheimer’s disease,” commented
Kevin N. Ramdas, MD, MPH, Director, Medical Affairs at Longeveron.
“We look forward to initiating the trial by year-end, or in the
first quarter of 2022.”
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 life-threatening conditions. Longeveron is conducting
clinical research in the following indications/conditions: 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.
About Biorasi:
Biorasi is an award-winning contract research
organization accelerating drug and device clinical development for
life sciences companies around the world. Since 2002, Biorasi has
achieved success in bringing innovative therapies to market by
forming true partnerships with sponsors, and focusing on processes,
methodologies, and technologies that move the industry forward.
Biorasi is headquartered in Miami, Florida, and has regional
offices around the globe.
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.
Contact:Brendan PayneStern Investor
RelationsTel: (212) 362-1200Email: Brendan.payne@sternir.com
Source: Longeveron IncSource: LGVN
Source: Longeveron
Longeveron (NASDAQ:LGVN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Longeveron (NASDAQ:LGVN)
Historical Stock Chart
From Sep 2023 to Sep 2024