San Diego, CA -- September. 14, 2022 -- InvestorsHub
NewsWire -- Sigyn Therapeutics, Inc. (OTCQB:
SIGY), a development-stage company focused on the creation of
therapeutic solutions that address unmet needs in global health,
announced today that it plans to pursue first-in-human feasibility
studies of Sigyn Therapy in End-Stage Renal Disease (ESRD) patients
suffering from excess inflammation and/or endotoxemia.
Inflammation and endotoxemia are prevalent conditions associated
with increased mortality in dialysis dependent ESRD patients.
According to the United States Renal Data System (USRDS), there are
more than 550,000 individuals with ESRD, which results in
approximately 85 million dialysis treatments being administered in
the United States each year. At present, there are no approved
drugs to treat ESRD related inflammation and endotoxemia. In
this regard, Sigyn Therapy offers a candidate strategy to improve
the health and quality-of-life of ESRD patients.
In the Company’s proposed study, Sigyn Therapy will be combined
in series with enrolled subjects regularly scheduled dialysis
treatment. Sigyn Therapy is broad-spectrum blood purification
technology that isolates and extracts pathogen sources of
life-threatening inflammation in concert with the depletion of
proinflammatory cytokines from the bloodstream.
“In recent months, we identified and initiated an evaluation of
ESRD inflammation and endotoxemia as a candidate indication to
demonstrate initial safety of Sigyn Therapy in human studies,”
stated Sigyn Therapeutics founder and CEO Jim Joyce. “From a
clinical execution perspective, we concluded it would be
advantageous to incorporate Sigyn Therapy in series with normally
scheduled dialysis treatments of enrolled ESRD patients with
established blood access. We also believe that the high
incidence of ESRD inflammation and endotoxemia may optimize patient
enrollment in a non-intensive care environment and allow for the
collection of secondary data endpoints that will contribute to the
potential advancement of Sigyn Therapy in other indications,”
concluded Joyce.
In addition to evaluating the safety of Sigyn Therapy in health
compromised ESRD patients, the Company plans to quantify changes in
circulating levels of endotoxin (gram-negative bacterial toxin) and
inflammatory cytokines including, tumor necrosis factor-a (TNF-a),
interleukin-1b (IL-1-b), and interleukin-6 (IL-6) before and after
each administration of Sigyn Therapy. Previously
conducted in vitro studies have validated the
ability of Sigyn Therapy to address each of these therapeutic
targets, which are also associated with sepsis (leading cause of
hospital deaths worldwide), community-acquired pneumonia (a leading
cause of death among infectious diseases) and emerging pandemic
threats.
Based on its disclosed intent to enroll ESRD patients, the
Company is updating an Investigational Device Exemption (IDE) that
it drafted for submission to the U.S. Food and Drug Administration
(“FDA”) related to the potential initiation of human feasibility
studies. However, there is no assurance that human feasibility or
pivotal studies will demonstrate Sigyn Therapy to be a safe and
efficacious treatment for any candidate treatment indication.
The Company further reported that it has downgraded its clinical
interest in treating hepatic encephalopathy and other
liver-associated disorders at this time.
Summary of Candidate Treatment Indications
Candidate treatment indications for Sigyn Therapy are primarily
comprised of pathogen-associated inflammatory disorders that are
not addressed with approved drug therapies.
ESRD Inflammation & Endotoxemia
According to the USRDS, more than 550,000 individuals suffer
from end-stage renal disease (ESRD), which results in approximately
85 million kidney dialysis treatments being administered in the
United States each year. Persistent inflammation is a hallmark
feature of ESRD dialysis patients as reflected by the excess
production of inflammatory cytokines, including tumor necrosis
factor-a (TNF-a), interleukin-1b (IL-1b) and interleukin-6 (IL-6),
which contribute to increased all-cause mortality. ESRD
inflammation can also induce intestinal permeability, which allows
endotoxin (gram-negative bacterial toxin) to translocate from the
gut and into the bloodstream. Beyond fueling further inflammation,
endotoxin is a potent activator of sepsis, which can lead to
multiple organ failure and death.
At present, there are no approved drugs to treat excessive
inflammation and endotoxemia that commonly occurs in end-stage
renal disease patients.
Sepsis
Sepsis is defined as a life-threatening organ dysfunction caused
by a dysregulated host response to infection. In January of 2020, a
report entitled; “Global, Regional, and National Sepsis
Incidence and Mortality,” was published in the Journal
Lancet. The publication reported 48.9 million cases of sepsis and
11 million deaths in 2017. In that same year, an estimated 20.3
million sepsis cases and 2.9 million deaths were among children
younger than 5-years old. In the United States, sepsis was reported
to be the most common cause of hospital deaths with an annual
financial burden that exceeds $24 billion.
At present, there are no approved drugs to treat sepsis, which
is commonly induced by a viral or bacterial infection. Sigyn
Therapy establishes a strategy to address a broad-spectrum of
pathogen sources in concert with controlling dysregulated cytokine
production (the cytokine storm), which is a hallmark of sepsis.
Community Acquired Pneumonia
According to the American Thoracic Society, Community Acquired
Pneumonia (CAP) is a leading cause of death among infectious
diseases, the leading cause of death in children under five years
of age, and a catalyst for approximately 50% of sepsis and septic
shock cases. In the United States, more than 1.5 million
individuals are hospitalized with CAP each year, resulting in an
annual financial burden that exceeds $10 billion.
In a recent study of 2,259 patients hospitalized with pneumonia,
ninety seven percent (97%) of cases were either viral or bacterial
in origin. Sigyn Therapy offers a broad-spectrum mechanism to
deplete the bloodstream presence of viral pathogens and bacterial
toxins. Additionally, Sigyn Therapy may assist to control the
excess production of inflammatory cytokines that can lead to
sepsis.
Emerging Pandemic Threats
Covid-19 affirmed the use of extracorporeal blood purification
devices as first-line countermeasures to treat an emerging pandemic
threat. On March 24, 2020, the U.S. Department of Health and Human
Services (HHS) declared that the emergence of COVID-19 justified
the Emergency-Use Authorization (EUA) of drugs, biological
products, and medical devices to combat the pandemic. Within a
month, the FDA awarded an EUA to four different blood purification
therapies. In connection with these authorizations, FDA published a
statement that blood purification devices may be effective at
treating patients with confirmed COVID-19 by reducing various
pathogens, cytokines, and other inflammatory mediators from the
bloodstream.
Consistent with FDA’s statement, Sigyn Therapy addresses
pathogen sources of life-threatening inflammation in concert with
the broad-spectrum depletion of cytokines and other inflammatory
mediators from the bloodstream. Sigyn Therapy provides a candidate
strategy to address future pandemic outbreaks, which are
increasingly being fueled by a confluence of global warming, urban
crowding, and intercontinental travel.
Sigyn Therapy also aligns with HHS initiatives established
through the Public Health Emergency Medical Countermeasure
Enterprise (PHEMCE) that support the development of broad-spectrum
medical countermeasures that can mitigate the impact of an emerging
pandemic, yet also have viability in established disease
indications.
About Sigyn Therapeutics™
Sigyn Therapeutics is a development-stage company focused on the
creation of therapeutic solutions that address unmet needs in
global health.
Sigyn Therapy™ is a broad-spectrum blood purification device
designed to address pathogen-associated inflammatory disorders that
are not addressed with an approved drug therapy. To accomplish such
unmet medical needs, Sigyn Therapy extracts pathogen sources of
life-threatening inflammation in concert with dampening down the
dysregulated overproduction of inflammatory cytokines.
In vitro blood purification studies have
demonstrated the potential of Sigyn Therapy to address a
broad-spectrum of relevant therapeutic targets, including endotoxin
(gram-negative bacterial toxin); peptidoglycan and lipoteichoic
acid (gram-positive bacterial toxins); viral pathogens (including
SARS-CoV-2); CytoVesicles (extracellular vesicles that transport
inflammatory cytokine cargos); and tumor necrosis factor alpha (TNF
alpha), interleukin-1 beta (IL-1b), and interleukin 6 (IL-6), which
are inflammatory cytokines that play a prominent role in each Sigyn
Therapy treatment indication. Subsequent to these milestone
achievements, Sigyn Therapy has been demonstrated to be well
tolerated in animal studies.
Based on Sigyn Therapy’s ability to isolate and extract viral
pathogens, bacterial toxins, and inflammatory cytokines from the
bloodstream, candidate treatment indications include
pathogen-associated sepsis (leading cause of hospital deaths),
community acquired pneumonia (a leading cause of death among
infectious diseases), emerging pandemic threats, and inflammation
& endotoxemia that commonly occurs in end-stage renal disease
patients.
To learn more about our therapeutic endeavors, market
opportunities and management team, we encourage to visit our
website at: www.SigynTherapeutics.com
Cautionary Note Regarding Forward-Looking Statements
This information in this press release contains forward-looking
statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve
substantial risks and uncertainties. All statements contained in
this summary are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 that involve risks and
uncertainties. Statements containing words such as "may,"
"believe," "anticipate," "expect," "intend," "plan," "project,"
"will," "projections," "estimate," "potentially" or similar
expressions constitute forward-looking statements. Such
forward-looking statements are subject to significant risks and
uncertainties and actual results may differ materially from the
results anticipated in the forward-looking statements. These
forward-looking statements are based upon Sigyn's current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Factors that may contribute to such
differences may include, without limitation, the Company's ability
to clinically advance Sigyn Therapy in human studies required for
market clearance, the Company's ability to manufacture Sigyn
Therapy, the Company's ability to raise capital resources, and
other potential risks. The foregoing list of risks and
uncertainties is illustrative but is not exhaustive. Additional
factors that could cause results to differ materially from those
anticipated in forward-looking statements can be found under the
caption "Risk Factors" in the Company's Annual Report on Form 10-K
for the year ended December 31, 2021, and in the Company's other
filings with the Securities and Exchange Commission, including its
quarterly Reports on Form 10-Q. All forward-looking statements
contained in this report speak only as of the date on which they
were made. Except as may be required by law, the Company does not
intend, nor does it undertake any duty, to update this information
to reflect future events or circumstances.
Contacts:
Stephen Kilmer
Sigyn Therapeutics, Inc.
Investor Relations
(646) 274-3580
stephen@sigyntherapeutics.com
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