BioRestorative Therapies Announces cGMP Cell Manufacturing Facility Certification
April 04 2022 - 8:00AM
BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”)
(NASDAQ: BRTX), a clinical stage company focused on stem cell-based
therapies, today announced that it has completed testing and
certification of its clinical grade cell therapy manufacturing
facility.
The cGMP manufacturing facility is a three suite
ISO 7 certified clean room environment. The facility will support
BioRestorative’s clinical manufacturing needs for its active Phase
2 clinical trial targeting chronic lumbar disc disease.
BioRestorative’s Phase 2 trial is a double-blind
controlled, randomized study to evaluate the safety and preliminary
efficacy of a single dose intradiscal injection of BRTX-100, its
lead cell therapy candidate. A total of up to 99 eligible patients
will be randomized across 15 clinical sites in the United States to
receive either the investigational drug (BRTX-100) or control. It
is anticipated that the first patient will be treated during the
second quarter of 2022.
“Possessing the capability to produce clinical
grade therapeutics in-house provides us with valuable quality
control and oversight in connection with our Phase 2 clinical trial
manufacturing process. The importance of ensuring that BRTX-100 is
produced under the defined standards of quality and release
criteria cannot be overly emphasized”, said Lance Alstodt, the
Company’s CEO.
In addition to supporting the manufacturing
needs for the BRTX-100 Phase 2 trial, BioRestorative’s facility
will also provide clinical production of the Company’s pipeline of
clinical and investigational cell therapy candidates.
The new facility provides cGMP manufacturing
according to the U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) regulations and guidelines to
support clinical grade cell production.
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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