BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
April 16 2024 - 7:45AM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX
), a clinical stage company
focused on stem cell-based therapies, today announced that the U.S.
Food and Drug Administration (“FDA”) has cleared an important
amendment to the protocol of the ongoing Phase 2 study
investigating the use of BRTX-100, the Company’s lead cell therapy
candidate, in treating chronic lumbar disc disease (“cLDD”). The
protocol amendment removes saline injection in the control arm of
the study and replaces it with a sham injection.
“The FDA clearance of this important amendment
highlights our positive relationship with the agency, brings
additional safety to our subject participants, and helps preclude
the possibility of transient clinical outcomes in the control
group, which can impact end of study readouts,” said Lance Alstodt,
BioRestorative’s Chief Executive Officer. “To further clarify,
control patients in our Phase 2 clinical trial will now have a
needle placed in close proximity to the target disc, but the disc
will not be pierced, nor will it have saline injected into it. This
positive change in our protocol will not have any impact from a
timing perspective, affirming our already established 2024
enrollment completion target.”
BRTX-100, a novel cell-based therapeutic
engineered to target areas of the body that have little blood flow,
is the Company’s lead clinical candidate. The safety and efficacy
of BRTX-100 in treating cLDD is being evaluated in a Phase 2,
prospective, randomized, double-blinded and controlled study. A
total of up to 99 eligible subjects will be enrolled at up to 16
clinical sites in the United States. Subjects included in the trial
will be randomized 2:1 to receive either BRTX-100 or placebo.
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.
• 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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