BioRestorative Therapies Receives Unanimous Recommendation from Data Safety Monitoring Board (DSMB) to Continue its Phase 2 Clinical Trial without any Changes
27 June 2023 - 9:00PM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX), a clinical stage company focused on stem
cell-based therapies, today announced that the independent Data
Safety Monitoring Board (“DSMB”), which is overseeing the Company’s
ongoing Phase 2 clinical trial to treat chronic lumbar disc disease
(“cLDD”), unanimously recommended the continuation of
BioRestorative’s study in accordance with the current version of
the protocol with no changes. The treated patients will receive
BRTX-100, a product formulated from autologous (or a person’s own)
hypoxic cultured mesenchymal stem cells collected from the
patient’s bone marrow and autologous platelet lysate. Three
patients in the safety run-in group received an intradiscal
injection of 40,000,000 hypoxic cultured mesenchymal stem cells and
one patient received an injection of saline placebo. This safety
run-in was used to evaluate the safety and dose limiting toxicity
of BRTX-100. There were no DLTs observed in the patients within the
safety run segment of the study. Based on the clinical results of
the safety run-in segment of the Phase 2 trial, the DSMB
recommended that the Company be permitted to commence open
enrollment of the 99 patient study. Each of these additional
patients (other than those receiving a placebo) will be treated
with BRTX-100, which includes 40,000,000 hypoxic cultured
mesenchymal stem cells.
"This unanimous recommendation of the DSMB to
allow BioRestorative to proceed without any changes to the protocol
represents a significant binary outcome and major milestone for the
continuation of our clinical program. With the safety profile of
BRTX-100 now established through the DSMB process, we intend to
accelerate the enrollment of the balance of our 99 patient study.
In addition and more importantly, we intend to leverage the product
technology platform across multiple indications further extending
our pipeline opportunities," said Lance Alstodt, CEO of
BioRestorative Therapies.
“The results of this in-depth safety review by
an unbiased team of independent experts provides us with great
confidence,” said Francisco Silva, Vice President of Research and
Development of BioRestorative Therapies. “The DSMB, which includes
experts in chronic lumbar disc disease, has recommended that the
study continue at the present dosage of cells. A DSMB
recommendation is a critical step towards confirming the safety of
our BRTX-100. We hope that the treatment of the next set of
patients will provide further evidence that BRTX-100 is a safe and
effective treatment option for patients with chronic lumbar disc
disease.”
The Company’s Phase 2 clinical trial to treat
chronic lumbar disc disease is prospective, randomized,
double-blinded and controlled. The multi-center trial will evaluate
the safety and preliminary efficacy of a single dose of BRTX-100. A
total of up to 99 eligible patients will be randomized at up to 15
clinical sites in the United States. The patients will receive
either the investigational drug (BRTX-100) or a placebo in a 2:1
fashion.
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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