BioRestorative Therapies Announces Key Milestone of Dosing Completion in Safety Cohort of Phase 2 Trial Targeting Chronic Lumbar Disc Disease
June 12 2023 - 7:00AM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ: BRTX ), a clinical stage company
focused on stem cell-based therapies, today announced that the
final subject in its BRTX-100 Phase 2 clinical trial safety cohort
has been dosed. Four study participants were dosed at a 3:1 ratio
with either BRTX-100 or control.
BRTX-100, the Company’s lead clinical candidate,
is a novel cell-based therapeutic engineered to target areas of the
body that have little blood flow. BRTX-100 is currently being
evaluated in a Phase 2 clinical trial to treat chronic lumbar disc
disease (“cLDD"). The trial is prospective, randomized,
double-blinded and controlled. The trial will evaluate the safety
and preliminary efficacy of a single dose of BRTX-100, with 40
million cells intradiscally injected into the nucleus of the lumbar
disc. A total of up to 99 eligible patients will be randomized at
up to 15 clinical sites in the United States to receive either the
investigational drug (BRTX-100) or control in a 2:1 fashion.
The initial safety run-in part of the study is
intended to assess the initial safety of a dose of BRTX-100. If no
dose limiting toxicity (“DLT”) occurs among the four BRTX-100
treated subjects, enrollment will transition and expand to the 2:1
randomization scheme planned for the main component of the study.
Establishing the safety profile and DLT of patients dosed with
BRTX-100 will allow for open enrollment across all activated
clinical sites participating in the clinical trial and accelerate
patient recruitment.
“We are excited to announce this important
clinical milestone as we continue to drive the development of
BRTX-100 as a potential treatment for patients suffering from lower
back pain,” said Lance Alstodt, CEO of BioRestorative. "I am
extremely impressed with the effort of our clinical and operational
teams, working collectively throughout the early stages of the
trial to coordinate and successfully complete dosing our safety
cohort. Open enrollment will enable us to rapidly increase patient
recruitment and allow us to work toward the completion of our Phase
2 trial.”
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. We have commenced a
Phase 2 clinical trial using BRTX-100 to treat chronic
lower back pain arising from degenerative disc disease. We are also
investigating the expansion of the clinical application
of BRTX-100 to other indications within the body.
• 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. 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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