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Sigyn Therapy™ demonstrates the
ability to address viral pathogens, including SARS-CoV-2 (COVID-19)
SAN DIEGO, CA – 
Therapeutics, Inc. (OTCMarkets: SIGY), a medical technology company focused on the
treatment of life-threatening inflammatory conditions precipitated by Cytokine Storm
Syndrome (the Cytokine Storm), today disclosed initial in vitro study observations
that demonstrated the ability of Sigyn Therapy™ to adsorb viral pathogens, including
SARS-CoV-2 (COVID-19).
Cytokine Storm Syndrome is an excessive
response of the immune system that is induced by infectious and non-infectious conditions.
A hallmark indicator of Cytokine Storm Syndrome is the excessive or uncontrolled
release of pro-inflammatory cytokines, which can lead to multiple organ failure
and cause death. The annual market opportunity to address Cytokine Storm related
indications exceeds $20 billion and includes sepsis, the most common cause of hospital
deaths worldwide. Virus-induced Cytokine
Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19)
infections.
In the in vitro study, Sigyn reported
the ability of the adsorbent components incorporated within Sigyn Therapy to address
viral pathogens, including COVID-19. As the
result of a two-hour exposure to Sigyn’s adsorbent components, the presence of SARS-CoV-2
pseudotyped lentivirus was reduced by 68.8% from plasma. SARS-CoV-2 pseudotyped
lentivirus is an established model previously utilized to study the development
of antiviral drugs to treat COVID-19 and to assess the efficacy of vaccines against
COVID-19 variants.
Sigyn Chairman and CEO, Jim Joyce
stated: “While our first viral depletion observation may be compelling, we recognize
this to be the first of several steps to validate viral depletion in combination
with pro-inflammatory cytokine elimination as an effective strategy to mitigate
virus-induced cytokine storms.”
Sigyn Therapeutics further disclosed
that it submitted a provisional patent application to the United States Patent and
Trademark Office (USPTO) to protect this new discovery.
Sigyn Therapy is a proprietary blood
purification technology designed to overcome the limitations of previous drug and
device candidates to treat acute inflammatory conditions. Incorporated within Sigyn
Therapy is a cocktail of adsorbent components with unique binding and capture characteristics
to optimize the broad-spectrum depletion of inflammatory targets from the bloodstream.
The single-use medical device is designed for use on the established infrastructure
of dialysis and CRRT machines already located in hospitals and clinics worldwide.
Since December 1, 2020, the Company
has reported results from several in vitro studies designed to validate the capability
of Sigyn Therapy to address a broad-spectrum of inflammatory targets.
Included among these studies was
the simultaneous capture of endotoxin and relevant pro-inflammatory cytokines, which
included Interleukin-1 Beta (IL-1B), Interleukin-6 (IL-6) and Tumor Necrosis Factor
alpha (TNF-a). Endotoxin (lipopolysaccharide or LPS) is a potent mediator implicated
in the pathogenesis of sepsis and septic shock.
The dysregulated over-production of IL-1B, IL-6 and TNF-a can induce organ
failure and cause death. An objective of this study was to rebalance elevated cytokine
levels and optimize the elimination of endotoxin from human blood plasma. The study
was conducted in triplicate over four-hour time periods with a pediatric version
of Sigyn Therapy. Average reduction of endotoxin
load peaked at 83% during the studies. The average reduction of IL-1B was 69%, IL-6
reduction was 59% and TNF-a reduction was 57% during the four-hour studies.
Sigyn Therapeutics has also reported
the results of an in vitro pilot study that modeled the ability of Sigyn Therapy™
to address CytoVesicles that transport inflammatory cytokine cargos in the bloodstream. CytoVesicles (extracellular vesicles that transport
inflammatory cytokine cargos) participate in concert with freely circulating cytokines
to further escalate Cytokine Storm Syndrome.
CytoVesicles have previously been an elusive target as they can be 20-60
times larger than cytokines themselves. In
the in vitro pilot study, 104nm liposomes were utilized as a model system to assess
the ability of Sigyn Therapy’s adsorbent components to deplete CytoVesicles from
human blood plasma. After a two-hour interaction
with Sigyn’s adsorbent components, liposome concentrations in human blood plasma
were reduced ~90%. Previously published studies
have validated liposomes as a model for the isolation of extracellular vesicles
from blood based on the similarity of their size and structural characteristics.
The resulting data from each of
these studies will be incorporated into an Investigational Device Exemption (IDE)
that Sigyn Therapeutics plans to submit to the United States Food and Drug Administration
(FDA) in 2021.
About Sigyn Therapeutics
Sigyn Therapeutics™ is a development-stage
therapeutic technology company headquartered in San Diego, California USA. Our focus
is directed toward a significant unmet need in global health; the treatment of life-threatening
inflammatory conditions that are precipitated by Cytokine Storm Syndrome and not
addressed with an approved therapy. Our mission is to save lives.
Sigyn Therapy™ is a novel blood
purification technology designed to mitigate cytokine storm syndrome through the
broad-spectrum depletion of inflammatory targets from the bloodstream. Cytokine
storm syndrome is the hallmark of sepsis, which is the most common cause of in-hospital
deaths and claims more lives each year than all forms of cancer combined. Virus
induced cytokine storm (VICS) is associated with high mortality and is a leading
cause of SARS-CoV-2 (COVID-19) deaths. Other therapeutic opportunities include but
are not limited to bacteria induced cytokine storm (BICS), acute respiratory distress
syndrome (ARDS) and acute forms of liver failure, such as hepatic encephalopathy.
To learn more, visit www.SigynTherapeutics.com
or www.SigynTherapy.com
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks
and uncertainties. All statements contained in this press release are forward-looking
statements within the meaning of The Private Securities Litigation Reform Act of
1995. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,”
“expect,” “potential,” or the negative of these terms or other similar expressions
are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. These forward-looking statements include,
among others, statements about Sigyn’s future financial performance, the impact
of management changes, any proposed organizational restructuring, results of operations,
capital resources to fund operations; statements about Sigyn’s expectations regarding
the capitalization, resources and ownership structure of the combined company; statements
about the potential benefits of the transaction; the expected completion and timing
of the transaction and other information relating to the transaction; and any other
statements other than statements of historical fact. Actual results or events could
differ materially from the plans, intentions and expectations disclosed in the forward-looking
statements that Sigyn makes due to a number of important factors, including (i)
the risk that the transaction may not be completed in a timely manner or at all,
which may adversely affect Sigyn’s business and the price of the common stock of
Sigyn, (ii) the failure to satisfy of the conditions to the consummation of the
transaction, (iii) the occurrence of any event, change or other circumstance that
could give rise to the termination of the merger agreement, (iv) risks related to
the ability to realize the anticipated benefits of the transaction, including the
risk that the businesses will not be integrated successfully, (v) the effect of
the announcement or pendency of the transaction on Sigyn’s business relationships,
operating results and business generally, (vi) risks that the proposed transaction
disrupts current plans and operations, (vii) risks related to the combined entity’s
ability to up-list to a national securities exchange, (viii) risks related to the
combined entity’s access to existing capital and fundraising prospects to fund its
ongoing operations, (ix) risks related to diverting management’s attention from
Sigyn’s ongoing business operations, (x) other business effects, including the effects
of industry, market, economic, political or regulatory conditions, future exchange
and interest rates, and changes in tax and other laws, regulations, rates and policies,
and (xi) risks related to an inability to manufacture Sigyn Therapy, risks related
to the clinical advancement of Sigyn Therapy with regulatory agencies, and no assurance
that Sigyn Therapy will be proven to be a safe and efficacious treatment for any
condition. The forward-looking statements in this press release represent Sigyn’s
views as of the date of this press release. Sigyn anticipates that subsequent events
and developments may cause its views to change. However, while it may elect to update
these forward-looking statements at some point in the future, it specifically disclaims
any obligation to do so. You should, therefore, not rely on these forward-looking
statements as representing Sigyn’s views as of any date subsequent to the date of
this press release.
Contact Sigyn Therapeutics, Inc.
Jim Joyce
Chairman, CEO
(619) 368-2000
jj@sigyntherapeutics.com
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