MIAMI, Nov. 05, 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, 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.
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)
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