BioRestorative Therapies Presents Preliminary Clinical Data from Phase 2 Study of BRTX-100 in Chronic Lumbar Disc Disease
February 05 2024 - 7:30AM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX), a clinical stage company focused on stem
cell-based therapies, today announced the public availability of a
poster, presented yesterday at the Orthopaedic Research Society
(ORS) 2024 Annual Meeting, which describes preliminary 26 and 52
week blinded data from the ongoing Phase 2 clinical trial of the
Company’s lead clinical candidate, BRTX-100, in subjects with
chronic lumbar disc disease (“cLDD”).
The presented poster, titled “Autologous Stem
Cell Therapy for Chronic Lumbar Disc Disease; Initial Phase 2
Clinical Safety and Feasibility Data of Intradiscal Injections of
Hypoxic Cultured Mesenchymal Stem Cells” can be accessed on the
Company’s website at www.biorestorative.com under “Scientific
Publications” in the Product Candidate section. During a webcasted
conference call scheduled for 8:30am EST today, BioRestorative
management will be available to discuss data from the presentation
as well as provide a clinical update.
Previous clinical studies have demonstrated that
the harsh microenvironment of the disc could impact cell dose
viability and result in a non-efficacious or the worsening of
clinical outcomes. Although this is blinded and early clinical
data, it is important to note that the Visual Analog Scale,
Oswestry Disability Index, Roland Morris Disability Questionnaire,
and Functional Rating Index collected at weeks 26 and 52
post-injection demonstrated a positive trend compared to baseline.
In addition to safety outcomes, changes to these pain and function
scales compared to baseline are used by the U.S. Food and Drug
Administration (FDA) to determine whether the trial will be allowed
to proceed and ultimately gain Biologics License Application (BLA)
approval.
“We are thrilled with the progress of our
ongoing clinical development programs. With regard to the Phase 2
study investigating the use of BRTX-100 in the treatment of cLDD,
we are strongly encouraged by the preliminary data presented at ORS
2024. The preliminary clinical data shows meaningful signals in
patients enrolled in the study and, importantly, no notable safety
signals,” said Lance Alstodt, Chief Executive Officer of
BioRestorative.
Conference Call & Webcast
Information
BioRestorative management will host a webcasted
conference call with an associated slide presentation today,
February 5, at 8:30AM EST. To join the conference call via phone
and participate in the live Q&A session, please dial
888-506-0062 (United States) or 973-528-0011 (International),
participant access code 234972. The live webcast and audio archive
of the presentation may be accessed on the investor section of the
BioRestorative website at
https://www.biorestorative.com/investor-relations/. An archived
replay will be available for approximately 90 days following the
event.
About BRTX-100
BRTX-100, a novel cell-based therapeutic
engineered to target areas of the body that have little blood flow,
is the Company’s lead clinical candidate. The safety and efficacy
of BRTX-100 in treating cLDD is being evaluated in a Phase 2,
prospective, randomized, double-blinded and controlled study. A
total of up to 99 eligible subjects will be enrolled at up to 16
clinical sites in the United States. Subjects included in the trial
will be randomized 2:1 to receive either BRTX-100 or control.
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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