BioRestorative Therapies Enters Agreement with Regenexx, Granting BRTX Exclusive License Rights for Intellectual Property Related to the Development and Commercialization of its BRTX-100® Disc Program to Treat Chronic Lumbar Disc Disease
December 05 2022 - 7:00AM
BioRestorative Therapies, Inc.
(“BioRestorative” or the
“Company”) (NASDAQ:
BRTX), a clinical stage company
focused on stem cell-based therapies, today announced an agreement
with Regenexx, LLC pursuant to which the license rights granted by
Regenexx to the Company for intellectual property developed to
address chronic lumbar disc disease have been made exclusive. The
intellectual property now exclusively licensed to the Company
represents important technological framework for BRTX’s disc/spine
technology related to the Company’s BRTX-100® lead
clinical program, currently in a Phase 2 trial with approximately
15 sites selected across the United States. The intellectual
property was developed in the lab of Dr. Christopher Centeno. Dr.
Centeno has been a leader in the field of cellular therapy for
musculoskeletal indications for over 17 years.
“This is an important event for BioRestorative.
We are thrilled to now have through this agreement an exclusive
license with regard to Regenexx’s technology,” said Lance Alstodt,
Chief Executive Officer at BioRestorative. “With this agreement,
coupled with our unique in-house research and manufacturing
capabilities, we aim to create a new generation of cell-based
products to induce long-term and sustained pain relief for patients
suffering from musculoskeletal indications. Approximately $40
billion is spent annually on invasive surgical procedures. With
BRTX-100, the Company is seeking to provide a paradigm shifting,
non-invasive solution to millions of patients worldwide.”
The BRTX-100 platform is a cell-based technology
that utilizes low oxygen (hypoxia) to engineer the cells’
modulation strategy to repress or activate transcription of target
genes related to tissue remodeling. Data from early
investigator-initiated human studies suggest a potential for this
platform to regulate target hypoxia-dependent gene expression as a
means to improve upon both the efficacy and safety of
first-generation cell-based therapies.
“Regenexx is excited to have granted exclusive
license rights to BioRestorative and support their efforts as they
continue to develop the technology through the regulatory pathway.
We have a great deal of clinical experience with positive clinical
outcomes using this technology. We are grateful that BioRestorative
is working to provide access to this product to the many patients
who are currently left with minimal options that are less effective
and more economically inefficient.” said Christopher Centeno MD,
Founder and Chief Medical Officer for Regenexx, LLC.
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. Pursuant to
authorization received from the Food and Drug Administration, 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 and other public
filings. 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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