BioRestorative Therapies Announces SBIR Phase I Grant to Explore the Therapeutic Effects of ThermoStem Targeting Polycystic Ovary Syndrome as an Indication
December 06 2022 - 9:52AM
InvestorsHub NewsWire
BioRestorative
Therapies Announces SBIR Phase I Grant to Explore the Therapeutic
Effects of ThermoStem® Targeting
Polycystic Ovary Syndrome as an Indication
--Non-Dilutive
Grant Funding to Support Development of Brown Adipose-Based
Therapeutic Programs Directed at Polycystic Ovary Syndrome
--
MELVILLE, NY
-- December 6, 2022 -- 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 it has been awarded a Small Business
Innovation Research (SBIR) Phase I grant from
the Eunice Kennedy Shriver
National Institute Of Child Health & Human Development of the
National Institutes of Health. This
collaborative research will be conducted in partnership
with Dr.
Sheng Wu, Associate
Professor, Center for Metabolic Disease Research at
Temple University, School of Medicine, Dr.
Wu has received numerous national and international awards such as
the Women in Endocrinology Young Investigator Award, Eugenia
Rosemberg Abstract Award, Early Investigator Award from the
Endocrine Society; Virendra B. Mahesh Award of Excellence in
Endocrinology, and Endocrinology and Metabolism Section New
Investigator Award from American Physiology Society.
The specific objective of this NIH grant is to enable the
development and evaluation of the
Company's ThermoStem® program
for the treatment of polycystic ovary syndrome
(PCOS). Therapeutic
brown adipocyte transplantation is an emerging and novel therapy
for PCOS. BRTX
has developed proprietary methods for the generation of
metabolically active brown adipocytes.
"This new indication will
expand BioRestorative's current discovery pipeline focused on the
novel brown fat therapy at the intersection of innate, adaptive
metabolic regulation and women's health. Our
industry expertise in brown fat complements world class research
conducted by Dr. Wu's laboratory and thus strengthen our commitment
to discover innovative solutions for patients with unmet medical
needs." said Lance
Alstodt, CEO of BioRestorative
Therapies.
PCOS affects 6-18% of
reproductive age females, representing the most common endocrine
disease in women and a $4.36 billion healthcare cost annually in
the US. PCOS causes gynecological,
dermatologic and metabolic comorbidities, and also imposes
long-term risks of diabetes mellitus type 2 (T2D), cardiovascular
diseases (CVD) and psychiatric problems including severe
depression.
PCOS is commonly associated with
metabolic disorders, with 50-70% of PCOS patients showing insulin
resistance and 10% with T2D, implying a potential causative link
between them. Current standard of care includes lifestyle changes
and multiple lines of medications with aims to relieve symptoms.
Medications usually have moderate success rates, and have limited
effects and long-term risks of T2D, CVD and psychiatric
problems
"There is a
tremendous gap in the understanding of the metabolic dysfunction
of PCOS and the underlying mechanisms remain largely incomplete. In
addition, the development of more efficient, even personalized
therapeutic strategies for the metabolic management of PCOS
patients persists as an unmet need. ThermoStem® may
provide a therapeutic option," said Francisco Silva, Vice President
of Research and Development of BioRestorative Therapies.
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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