MIAMI, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Longeveron
Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage
biotechnology company developing regenerative medicines for unmet
medical needs, today announced the completion of enrollment in its Phase
2a trial of Lomecel-BTM in patients with mild Alzheimer’s Disease (AD).
“We are pleased to have completed enrollment in our Phase 2a study of Lomecel-BTM
for Alzheimer’s Disease. We look forward to building on our Phase 1b
study, which met its primary endpoint of safety and was published in a
leading journal, Alzheimer’s and Dementia, the Journal of the Alzheimer’s Association this year. We are excited to advance our program designed to assess the therapeutic potential of Lomecel-BTM in patients with AD,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer of Longeveron.
The Phase 2a trial follows the previously announced positive results of Longeveron’s Phase 1b clinical trial of Lomecel-BTM
for AD. In that trial, the primary endpoint of safety was met. That
trial was a randomized, placebo-control design and included endpoints in
several domains, including measures of cognitive function and quality
of life, brain volumetry using magnetic resonance imaging, and
circulating biomarkers.
The Phase 2a trial, called the CLEAR
MIND trial, is a 48 patient, 4-arm, parallel design, randomized
(1:1:1:1) clinical trial of Lomecel-BTM to evaluate the
safety of single and multiple infusions of two different dose levels
compared to placebo in patients with mild AD. The primary endpoint is
safety as measured by the occurrence of serious adverse events (SAEs)
within the first 30 days after administration of Lomecel-BTM.
Secondary and exploratory endpoints include brain volumetry by magnetic
resonance imaging (MRI), biomarkers relevant to inflammation and
endothelial/vascular systems, and measures of cognitive function.
About Longeveron Inc.
Longeveron
is a clinical stage biotechnology company developing regenerative
medicines to address unmet medical needs. The Company’s lead
investigational product is Lomecel-B™, an allogeneic medicinal signaling
cell (MSC) therapy product isolated from the bone marrow of young,
healthy adult donors. Lomecel-B™ has a multi-modal mechanism of action
that is pro-vascular, pro-regenerative, and anti-inflammatory, promoting
tissue repair and healing with broad potential applications across a
spectrum of disease areas. Longeveron is advancing Lomecel-B™ through
clinical trials in three indications: Hypoplastic Left Heart Syndrome
(HLHS), Alzheimer’s Disease, and Aging Frailty. Additional information
about the Company is available at www.longeveron.com.
Certain
statements in this press release that are not historical facts are
forward-looking statements made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995, which 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. Factors that could cause
actual results to differ materially from those expressed or implied in
any forward-looking statements in this release include, but are not
limited to, statements about the ability of Longeveron’s clinical trials
to demonstrate safety and efficacy of the Company’s product candidates,
and other positive results; the timing and focus of the Company’s
ongoing and future preclinical studies and clinical trials and the
reporting of data from those studies and trials; the size of the market
opportunity for the Company’s product candidates, including its
estimates of the number of patients who suffer from the diseases being
targeted; the success of competing therapies that are or may become
available; the beneficial characteristics, safety, efficacy and
therapeutic effects of the Company’s product candidates; the Company’s
ability to obtain and maintain regulatory approval of its product
candidates; the Company’s plans relating to the further development of
its product candidates, including additional disease states or
indications it may pursue; existing regulations and regulatory
developments in the U.S., Japan and other jurisdictions; the Company’s
plans and ability to obtain or protect intellectual property rights,
including extensions of existing patent terms where available and its
ability to avoid infringing the intellectual property rights of others;
the need to hire additional personnel and the Company’s ability to
attract and retain such personnel; the Company’s estimates regarding
expenses, future revenue, capital requirements and needs for additional
financing; the Company’s need to raise additional capital, and the
difficulties it may face in obtaining access to capital, and the
dilutive impact it may have on its investors; the Company’s financial
performance, and the period over which it estimates its existing cash
and cash equivalents will be sufficient to fund its future operating
expenses and capital expenditures requirements. 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 Securities and Exchange Commission, including Longeveron’s Annual
Report on Form 10-K for the year ended December 31, 2021, filed with the
SEC on March 11, 2022, and the Company’s Quarterly Reports on Form 10-Q
for the periods ended March 31, and June 30, 2022. 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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