BioRestorative Therapies Announces First Patient Enrolled for the Company’s Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease (cLDD)
June 30 2022 - 7:30AM
BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”)
(NASDAQ: BRTX)
, a clinical stage company focused
on stem cell-based therapies, today announced that the first
patient has been enrolled in the Company’s Phase 2 clinical trial
evaluating the safety and preliminary efficacy of BRTX-100, an
autologous bone marrow-derived mesenchymal stem cell targeting
chronic lumbar disc disease (cLDD). The clinical study is being
conducted at up to 15 sites in the United States.
"Announcing first patient enrollment is our most
significant clinical milestone to date and an exciting milestone
for BioRestorative’s clinical programs overall,”
said Lance Alstodt, CEO of BioRestorative Therapies. “The
initiation of patient enrollment in our study reinforces our
commitment to treating back pain and is an important step in our
efforts to provide patients with potentially improved therapeutic
options to treat chronic lumbar disc disease. In addition, I am
very proud of the BRTX team for its timely execution. This truly
remarkable accomplishment of first patient enrolled in only 6
months from our trial initiation keeps us on schedule to meet our
strategic targets.”
BioRestorative’s Phase 2 trial is a double-blind
controlled, randomized study to evaluate the safety and preliminary
efficacy of a single dose intradiscal injection of the Company’s
autologous investigational stem cell-based therapeutic, BRTX-100. A
total of up to 99 eligible patients will be randomized at up to 15
centers in the United States to receive either the investigational
drug (BRTX-100) or control in a 2:1 fashion.
"Even with the rapid advancements in
regenerative medicine across many musculoskeletal disorders over
the last decade, there still remain many patients who continue to
face unmet needs and experience a high burden of pain and
disability," said Jason Lipitz, M.D., primary investigator in
the clinical trial. "With BioRestorative’s trial now underway, we
look forward to seeing the potential clinical impact
of BRTX-100 to treat chronic lumbar disc disease, which could
be a paradigm shift in treating back pain."
About
BioRestorative Therapies,
Inc.
BioRestorative Therapies, Inc.
(www.biorestorative.com) develops therapeutic products using cell
and tissue protocols, primarily involving adult stem cells. Our two
core programs, as described below, relate to the treatment of
disc/spine disease and metabolic disorders:
• Disc/Spine Program (brtxDISC™): Our lead cell
therapy candidate, BRTX-100, is a product formulated from
autologous (or a person’s own) cultured mesenchymal stem cells
collected from the patient’s bone marrow. We intend that the
product will be used for the non-surgical treatment of painful
lumbosacral disc disorders or as a complementary therapeutic to a
surgical procedure. The BRTX-100 production process utilizes
proprietary technology and involves collecting a patient’s bone
marrow, isolating and culturing stem cells from the bone marrow and
cryopreserving the cells. In an outpatient procedure, BRTX-100 is
to be injected by a physician into the patient’s damaged disc. The
treatment is intended for patients whose pain has not been
alleviated by non-invasive procedures and who potentially face the
prospect of surgery. Pursuant to authorization received from the
Food and Drug Administration, we have commenced a Phase 2 clinical
trial using BRTX-100 to treat chronic lower back pain arising from
degenerative disc disease.
• Metabolic Program (ThermoStem®): We are
developing a cell-based therapy candidate to target obesity and
metabolic disorders using brown adipose (fat) derived stem cells to
generate brown adipose tissue (“BAT”). BAT is intended to mimic
naturally occurring brown adipose depots that regulate metabolic
homeostasis in humans. Initial preclinical research indicates that
increased amounts of brown fat in animals may be responsible for
additional caloric burning as well as reduced glucose and lipid
levels. Researchers have found that people with higher levels of
brown fat may have a reduced risk for obesity and diabetes.
Forward-Looking Statements
This press release contains "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, and such forward-looking statements are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. You are cautioned that such
statements are subject to a multitude of risks and uncertainties
that could cause future circumstances, events or results to differ
materially from those projected in the forward-looking statements
as a result of various factors and other risks, including, without
limitation, those set forth in the Company's latest Form 10-K filed
with the Securities and Exchange Commission and other public
filings. You should consider these factors in evaluating the
forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in this
release are made as of the date hereof and the Company undertakes
no obligation to update such statements.
CONTACT:Email: ir@biorestorative.com
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