BioRestorative Therapies Receives Unanimous Recommendation from Data Safety Monitoring Board (DSMB) to Continue its Phase 2 Clinical Trial without any Changes
28 Juin 2023 - 1:00PM
InvestorsHub NewsWire
BioRestorative Therapies Receives Unanimous Recommendation from
Data Safety Monitoring Board (DSMB) to Continue its Phase 2
Clinical Trial without any Changes
MELVILLE, N.Y. -- June 27, 2023 -- InvestorsHub NewsWire --
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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