BioRestorative Therapies Announces Activation of Northwell Health in the Company's Phase 2 Clinical Trial Targeting Chronic Lumbar Disc Disease
September 08 2023 - 8:30AM
BioRestorative Therapies, Inc . (“BioRestorative”, “BRTX”
or the “Company”) (NASDAQ: BRTX ) , a clinical stage
company focused on stem cell-based therapies, today announced that
Northwell Health, New York State's largest health care
provider, has been activated and can now start recruitment in the
State of New York for BioRestorative’s ongoing Phase 2 clinical
trial targeting chronic lumbar disc disease (“cLDD”).
BioRestorative and Northwell Health entered into a clinical trial
agreement in May with regard to the Phase 2 trial. Much effort and
collaboration have taken place and, now that site specific training
is complete, the site can initiate patient recruitment and
enrollment.
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 and limited oxygen supply. It is
currently being evaluated in connection with the Company’s ongoing
Phase 2 clinical trial targeting cLDD. 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,
with 40 million cells injected into the lumbar disc that is causing
pain. 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 its safety run-in phase of the
Phase 2 trial and is now openly enrolling patients across all its
clinical sites located throughout the United States.
“I’m pleased to report that, after several
months of a deliberate and thoughtful collaboration with Northwell
Health, the largest healthcare provider and employer in New York
State, we have reached the point of initiating the patient
enrollment process. Given the size of Northwell Health and its
relative proximity to our facilities in Melville, New York, we look
forward to significant benefits from working with Northwell Health
in connection with our Phase 2 clinical trial. We hope that our
partnership will result in a highly efficient recruitment /
enrollment process among other significant benefits,” stated Lance
Alstodt, Chief Executive Officer of BioRestorative.
Dr. Sohrab Virk of Northwell Health
stated, “Everyone at Northwell is laser focused on improving
clinical outcomes related to the spine. The technology of BRTX-100
represents a new hope for improving pain/functionality for our
patients dealing with discogenic pain. We are eager to begin our
investigation and hope to bring the extensive clinical volume and
outstanding physician talent at Northwell to help with this
trial.”
Dr. Virk is an orthopedic surgeon who
specializes in the treatment of spine-related issues, specifically
using minimally invasive surgical techniques and motion sparing
technology. He is also an assistant professor of Orthopedic Surgery
at the Donald and Barbara Zucker School of Medicine at Hofstra
University.
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 Health
to begin active recruitment and enrollment 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 chronic lumbar 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
BioRestorative Therapies (NASDAQ:BRTX)
Historical Stock Chart
From Sep 2024 to Oct 2024
BioRestorative Therapies (NASDAQ:BRTX)
Historical Stock Chart
From Oct 2023 to Oct 2024