HOUSTON, Feb. 20,
2024 /PRNewswire/ -- FibroBiologics (Nasdaq: FBLG)
("FibroBiologics") is a clinical-stage biotechnology company with
150+ patents issued and pending with a focus on the development of
therapeutics and potential cures for chronic diseases using
fibroblasts and fibroblast-derived materials. FibroBiologics will
present in vitro and in vivo preclinical data using allogeneic
human dermal fibroblasts (HDFs) and HDF spheroids as well as
primary safety phase 0/1 clinical trial data for the
single-dose infusion of HDFs during the poster sessions at the
upcoming Americas Committee for Treatment and Research in Multiple
Sclerosis (ACTRIMS) Forum 2024 on Thursday,
February 29, at the Palm Beach
County Convention Center and the Hilton West Palm Beach in
West Palm Beach, Florida.
The National Institutes of Health describes multiple sclerosis
(MS) as a T-cell-mediated autoimmune disorder in which the immune
system targets and destroys the myelin sheath of axons in the
central nervous system, leading to severe and progressive cognitive
impairment, sensory deprivation, and weakened coordination.
FibroBiologics is investigating the therapeutic potential of using
HDFs as a treatment for MS through immune modulation and
stimulation of myelin expression by oligodendrocytes to rebuild the
damaged myelin sheath.
Extensive preclinical studies were conducted using allogeneic
HDFs in the experimental autoimmune encephalomyelitis (EAE) animal
model of MS. In vivo results indicated that HDFs significantly
suppressed Th17 cell activation, stimulated T regulatory (Treg)
cell expansion, inhibited dendritic cell maturation, reduced
microglial activation, and stimulated oligodendrocyte expansion and
remyelination. The results also demonstrated that administration
of HDFs in the EAE model significantly enhanced Treg-dependent
disease inhibition in a manner superior to adipose or bone
marrow-derived MSCs.
The phase 0/1 primary-safety clinical trial studied a
single-dose infusion of allogeneic HDFs into four
relapsing-remitting and one secondary progressive MS patients. The
primary outcome of the safety clinical trial indicated a strong
correlation for CBC, blood chemistry, and electrocardiogram data
for all patients compared with pre-infusion test results, and no
adverse events were reported.
"Our in vivo animal studies provided evidence that allogeneic
HDFs are capable of suppressing pathogenic T cell activation,
stimulating T regulatory (Treg) cell expansion, inhibiting
dendritic cell maturation, and stimulating oligodendrocyte
expansion and myelin protein expression," said Dr. Hamid Khoja, Chief Scientific Officer at
FibroBiologics. "Based on our results to date, we are enthusiastic
about the promise of HDFs for the treatment of MS, although we
understand that further study is required. In pursuit of that goal,
FibroBiologics is designing a phase II clinical trial to study the
safety and efficacy profile of various concentrations of HDF
spheroids and the effect of multiple-dose treatments over an
eighteen-month study period."
Abstract Information:
Title: The Potential of
Using Allogeneic Human Dermal Fibroblast Spheroids as a Biological
Extended-Release Therapy for the Treatment of Multiple Sclerosis:
Preclinical and Phase 0/1 Clinical Trial Results
Authors: H. Khoja, B. Jiang, P. O'Heeron
Session Title: PS1-Poster Session 1
Session Date and Time: February 29,
2024, 6:00 PM - 7:30 PM
Poster Number: P341
For more information, please visit FibroBiologics'
website or email FibroBiologics at:
info@fibrobiologics.com.
Cautionary Statement Regarding Forward-Looking
Statements
This communication may contain "forward-looking
statements" as defined in the Private Securities Litigation Reform
Act of 1995. Forward-looking statements include information
concerning FibroBiologics' possible or assumed future results of
operations, business strategies, debt levels, competitive position,
industry environment, potential growth opportunities and the
effects of regulation, including whether FibroBiologics will
generate returns for stockholders. These forward-looking statements
are based on FibroBiologics' management's current expectations,
estimates, projections and beliefs, as well as a number of
assumptions concerning future events. When used in this
communication, the words "estimates," "projected," "expects,"
"anticipates," "forecasts," "plans," "intends," "believes,"
"seeks," "may," "will," "should," "future," "propose" and
variations of these words or similar expressions (or the negative
versions of such words or expressions) are intended to identify
forward-looking statements. These forward-looking statements are
not guarantees of future performance, conditions or results, and
involve a number of known and unknown risks, uncertainties,
assumptions and other important factors, many of which are outside
FibroBiologics' management's control, that could cause actual
results to differ materially from the results discussed in the
forward-looking statements, including those set forth in the Risk
Factors section of FibroBiologics' Registration Statement for the
Direct Offering filed with the SEC. Copies are available on the
SEC's website, www.sec.gov. These risks, uncertainties, assumptions
and other important factors include, but are not limited to: (a)
the occurrence of any event, change or other circumstances that
could cause the Registration Statement to not become effective; (b)
the ability of FibroBiologics to continue to meet Nasdaq listing
requirements; (c) the ability to effectively manage the business as
a result of the super-voting proxy given to the Board of Directors.
Forward-looking statements speak only as of the date they are made.
Readers are cautioned not to put undue reliance on forward-looking
statements, and FibroBiologics assumes no obligation and, except as
required by law, does not intend to update or revise these
forward-looking statements, whether as a result of new information,
future events, or otherwise. FibroBiologics gives no assurance that
it will achieve its expectations.
About FibroBiologics
Based in Houston, FibroBiologics is a cell therapy,
regenerative medicine company developing a pipeline of treatments
and potential cures for chronic diseases using fibroblast cells and
fibroblast-derived materials. FibroBiologics holds 150+ US and
internationally issued patents/patents pending across various
clinical pathways, including disc degeneration, orthopedics,
multiple sclerosis, psoriasis, wound healing, reversing organ
involution, and cancer. FibroBiologics represents the next
generation of medical advancement in cell therapy. For more
information, visit www.FibroBiologics.com.
General Inquiries:
info@fibrobiologics.com
Investor Relations:
Nic
Johnson or Harrison Seidner,
Ph.D.
Russo Partners
212-845-4242
fibrobiologicsIR@russopr.com
Media Contact:
Liz
Phillips
Russo Partners
(347) 956-7697
Elizabeth.phillips@russopartnersllc.com
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