BioRestorative Therapies Awarded an STTR Phase I Grant to Explore the Therapeutic Effects of PEG-Peptide Hydrogel-Encapsulated Hypoxic Bone Marrow Stem Cells
January 04 2022 - 6:00AM
BioRestorative Therapies, Inc. (the “Company" or “BioRestorative”)
(NASDAQ:BRTX
), a life sciences company focused on
stem cell-based therapies, today announced that it has been awarded
a Small Business Technology Transfer (STTR) Phase I grant for
$256,000. The funds will be used specifically to evaluate the
therapeutic effects on the Company’s hypoxic cultured bone marrow
derived mesenchymal stem cells (BRTX-100) after encapsulation with
a PEG-peptide hydrogel. The work is being done in collaboration
with Dr. Lori Setton, Chair of the Department of Biomedical
Engineering at Washington University in St. Louis.
Dr. Setton developed the hydrogel from a PEG
backbone conjugated with a proprietary formulation of peptides
mimicking laminin and other matrix proteins selected for their
ability to modulate cell phenotype and biosynthesis. The STTR aims
to define the therapeutic potential and mechanism by which the
newly synthesized hydrogel can optimally support the therapeutic
delivery of hypoxic cultured bone marrow-derived stem cells.
“The National Institutes of Health funds
companies with the most innovative, cutting-edge ideas that have
the potential to become commercial successes and make important
societal impacts,” said Lance Alstodt, CEO of BioRestorative
Therapies.
“We are tremendously grateful and honored to
have been awarded this Phase I STTR. This collaboration is an
important milestone that demonstrates our commitment to developing
and expanding our product pipeline.”
All proposals submitted to the NIH SBIR/STTR
program undergo a rigorous merit-based review process. Once a small
business is awarded a Phase I SBIR/STTR grant (up to $256,000), it
becomes eligible to apply for a Phase II (up to $1,000,000). Small
businesses with Phase II funding are eligible to receive up to
$500,000 in additional matching funds with qualifying third-party
investment or sales.
“We are thrilled to collaborate with
BioRestorative Therapies on this project. By receiving this grant,
we will be able to evaluate the therapeutic benefits of our
PEG-peptide hydrogel in combination with BioRestorative’s hypoxic
cultured stem cells,” said Dr. Lori Setton, co-investigator on this
project.
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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