BioRestorative Therapies Announces CRO Agreement with PRC Clinical for its BRTX-100 Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease
December 21 2021 - 4:01PM
BioRestorative Therapies, Inc. (the “Company" or “BioRestorative”)
(NASDAQ:BRTX), a life sciences company focused on adult stem
cell-based therapies, today announced it has entered into a Master
Service Agreement with PRC Clinical, a contract research
organization (CRO) specializing in clinical trial management to
conduct BioRestorative’s Phase 2 clinical trial.
PRC Clinical is an all-inclusive CRO and has
specialized expertise across regenerative medicine, CNS,
ophthalmology, pulmonary and COVID-19, rare and orphan disease and
more complex indications. Their innovative approach to executing
studies for biotech and pharmaceutical companies combines
high-touch human elements and cutting-edge technology with
extensive experience and deep therapeutic knowledge. Pursuant to
the agreement, PRC Clinical will manage BioRestorative’s Phase 2
clinical study of BRTX-100, the Company’s lead clinical product to
treat chronic lumbar disc disease.
"This is a significant milestone in our mission
to develop cell-based therapeutics and to become a clinical stage
company. We believe that PRC's renowned expertise in conducting
clinicals trials and their use of innovative technology makes them
an excellent CRO to partner with," said Lance Alstodt, Chief
Executive Officer of BioRestorative Therapies. “This is the most
meaningful step the Company has taken to initiate our clinical
trial. We should now expect a host of developments pertaining to
the advancement of our clinical trial, ultimately leading to the
read out of our primary endpoints.”
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 received
authorization from the Food and Drug Administration to commence 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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