BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease
April 08 2024 - 7:45AM
BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the
“Company”) (NASDAQ:BRTX), a clinical stage company focused on stem
cell-based therapies, today announced a collaboration with Galen
Patient Recruitment, Inc. (“Galen”) which, combined with the recent
expansion of clinical trial capacity from approximately 10 to 30
participants per month, is expected to help accelerate the
completion of patient enrollment in the ongoing Phase 2 study of
BioRestorative’s lead clinical candidate, BRTX-100, in chronic
lumbar disc disease (“cLDD”).
BRTX-100 is a novel cell-based therapeutic
engineered to target areas of the body that have little blood flow.
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 placebo.
“The industry statistics can be sobering; around
80% of clinical trials fail to meet their initial enrollment
targets and timelines, with patient recruitment being the single
biggest cause of trial delays,”1 said Lance Alstodt, Chief
Executive Officer of BioRestorative. “With that in mind, we are
confident that our partnership with an industry leader like Galen
will help us achieve our 2024 enrollment goals by closing any gaps
that may exist in our current recruitment process.”
Reference
1 Brøgger-Mikkelsen M, Ali Z, Zibert JR,
Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical
Trials: Systematic Review and Meta-Analysis. J Med Internet Res.
2020 Nov 4;22(11):e22179. doi: 10.2196/22179. PMID: 33146627;
PMCID: PMC7673977.
About Galen Patient
Recruitment
Since 2006, Galen (www.galenrecruitment.com) has
helped its clients bring new medical innovations to market through
cost-effective patient recruitment solutions. Galen doesn’t believe
in one-size fits all. It approaches each study with a fresh
perspective, and considers all of the variables in the study
enrollment equation – the research sites, study coordinators and,
most importantly, the patients. This leads to comprehensive yet
flexible recruitment programs that take the guesswork out of
achieving enrollment goals.
About BioRestorative
Therapies
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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