BioRestorative Therapies and Northwell Health Enter into Agreement to Participate in the Company’s Phase 2 Clinical Trial
May 08 2023 - 7:00AM
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 signed a clinical trial agreement with Northwell Health, New
York State's largest health care provider and private
employer, and Northwell’s Feinstein Institutes for Medical
Research. The signing of the agreement will allow Northwell Health
to participate in BioRestorative Therapies ongoing Phase 2 clinical
trial targeting chronic lumber disc disease (cLDD).
BRTX-100, the Company’s lead clinical candidate,
is a novel cell-based therapeutic engineered to target areas of the
body that have little blood flow. BRTX-100 is currently being
evaluated in connection with a Phase 2 clinical trial to treat
cLDD. The BRTX-100 approach involves an office based injection
procedure which introduces the patient’s own cells which have been
uniquely expanded and conditioned to result in therapeutic impact
within the harsh environment of the intervertebral disc and for an
all too common pain which is otherwise not reliably treated. The
trial is prospective, randomized, double-blinded and controlled.
The 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 to
receive either the investigational drug (BRTX-100) or control in a
2:1 fashion. BioRestorative recently completed enrollment for the
safety run-in phase of its Phase 2 trial.
Lance Alstodt, Chief Executive Officer of
BioRestorative, stated, “Partnering with Northwell Health and
Northwell’s Feinstein Institutes for Medical Research, the largest
hospital system and health provider in New York State, is a
testament to the strength of our corporate profile, our technology
and the prospects for our product candidate, BRTX 100. We are
delighted to enter into such an agreement with Northwell and their
world class team of non-surgical and surgical spine clinicians and
researchers across the disciplines. We hope to identify other areas
where our two organizations can work closely with one another.
Research is a very obvious area of focus for both of us and we look
forward to exploring strategic possibilities to enhance and
strengthen our relationship with Northwell.”
Dr. Jeffry Beer, of Northwell, stated “Chronic
low back pain remains one of the most common and difficult clinical
conditions we encounter as spine specialists. We don’t currently
have highly effective treatment options. The current phase 2 FDA
trial is meticulously designed to provide us greater insight into
the role of this unique and autologous stem cell therapy.” Dr.
Jeffry R. Beer is a Voluntary Staff Physician at Long Island Jewish
Medical Center, Northwell Health; Clinical Assistant Professor,
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell;
and Partner, Long Island Spine Rehabilitation Medicine, PC, East
Meadow, NY.
Northwell Health is New York
State's largest health care provider and private employer,
with 21 hospitals, 850 outpatient facilities and more than 12,000
affiliated physicians. The partnership will enable Northwell to
participate in BioRestorative’s clinical trial targeting patients
suffering from chronic lumbar disc disease.
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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