SAN DIEGO, CA, Nov. 02, 2020 -- InvestorsHub NewsWire
-- Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), today released the following
note authored by its Chairman and CEO, Jim Joyce.
Dear Current and Candidate Shareholders,
We created Sigyn Therapy™ to address a significant unmet need in
global health; the treatment of life-threatening inflammatory
conditions that are precipitated by Cytokine Storm Syndrome (The
Cytokine Storm). The intent of this communication (the first in a
series) is to introduce and familiarize you with our technology and
therapeutic opportunities, which include large market indications
that remain beyond the reach of drug therapies.
Cytokine storm syndrome is characterized as a dysregulated
response of the immune system, which can be induced by a wide-range
of infectious and non-infectious conditions. Since the outset of
the current pandemic, medical journals have widely reported
cytokine storm syndrome to be a leading cause of death resulting
from severe COVID-19 infections. A hallmark of the cytokine storm
is an excessive or uncontrolled release of pro-inflammatory
cytokines, which can induce multiple organ failure and result in
death.
To recalibrate this dysregulated immune response, we designed
Sigyn Therapy to deplete a broad-spectrum of inflammatory
contributors from the bloodstream. The most prevalent condition
associated with cytokine storm syndrome is sepsis. Earlier
this year, the Journal Lancet reported that sepsis kills more
people around the world than all forms of cancer combined.
The Lancet reported that in 2017, there were 48.9 million cases of
sepsis and 11 million deaths. In that same year, the journal
reported 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
in-hospital deaths and accounted for more than $24 billion in
annual costs.
To date, more than 70 controlled human studies have been
conducted to evaluate the safety and benefit of candidate drugs to
treat sepsis. With one brief exception (Xigris from Eli Lilly),
none of these studies resulted in an approved drug therapy. When
considering the breadth of contributing inflammatory factors,
sepsis is likely to remain an elusive target for therapeutic drug
agents.
As a result of this therapeutic void, a significant opportunity
for non-pharmaceutical blood purification devices has emerged. In
this regard, I encourage you to learn about CytoSorbents
Corporation and Toray Industries, Inc. Both are
publicly-traded organizations that we highly respect for the
advancement of their respective CytoSorb and Toraymyxin devices.
Each of these industry pioneering devices are market cleared and
broadly deployed to treat a wide-range of inflammatory conditions
outside of the U.S. They are being clinically evaluated in
the U.S. as candidates to treat severe COVID-19 infection under
FDA-awarded Emergency Use Authorizations.
In regards to mechanism of action, Toraymyxin has a high
specificity to bind circulating endotoxin, which is reported to be
a potent activator of cytokine storm syndrome. However, the
Toraymyxin device does not address pro-inflammatory cytokines.
Conversely, the CytoSorb device incorporates an adsorbent component
that depletes pro-inflammatory cytokines from circulation, but does
not address endotoxin.
We designed Sigyn Therapy to deplete the presence of both
endotoxin and pro-inflammatory cytokines. To further optimize the
potential of our therapeutic outcomes, we expanded Sigyn Therapy’s
mechanism to include the elimination of larger proteins that
transport cytokines and other inflammatory cargos. We refer to
these as CytoVesicles. To address this breadth of targets, we
incorporate a cocktail of adsorbent components within Sigyn Therapy
that each have unique binding and capture
characteristics.
In the medical field, the term cocktail often refers to the
simultaneous administration of multiple drugs with differing
mechanisms of action. However, the dosing of multiple drugs is
limited by toxicity and adverse events that may result from
deleterious drug interactions. Sigyn Therapy is not constrained by
such limitations as our cocktail of adsorbent components are not
introduced into the body. As a result, we are able to
incorporate a substantial dose of multiple adsorbents, each with
differing mechanisms and capabilities to optimize the ability of
Sigyn Therapy to calm the cytokine storm that underlies
life-threatening inflammatory conditions.
Our therapeutic opportunities include, but are not limited to
sepsis, virus induced Cytokine Storm (VICS), bacteria induced
Cytokine Storm (BICS), acute respiratory distress syndrome (ARDS)
and acute forms of liver failure, including hepatic
encephalopathy.
To translate our therapeutic vision into a clinical reality, we
are planning a series of studies whose outcomes will be included in
an Investigational Device Exemption (IDE) that we intend to submit
to FDA in 2021. At present, we are conducting an in vitro study
designed to validate the ability of Sigyn Therapy to simultaneously
reduce the presence of endotoxin and relevant pro-inflammatory
cytokines from human blood plasma. In this study, our cytokine
targets include interleukin-6 (IL-6), interleukin-1 (IL-1) and
tumor necrosis factor alpha (TNF-a), which are each drug industry
targets to treat COVID-19 infected individuals.
Roche, Sanofi, Regeneron and EUSA Pharma are evaluating
anti-IL-6 drugs as COVID-19 treatment
candidates. Additionally, SOBI is testing an IL-1 inhibitor
and Amgen is evaluating the potential benefit of Enbrel to inhibit
TNF-a in COVID-19 infected individuals. The prospect of
aligning a therapeutic drug with a specific cytokine may be limited
as researchers at Stanford and Yale have reported that cytokine
profiles in those suffering from severe COVID-19 infection to be
consistent with those previously observed in sepsis patients.
We believe that a device with much broader capabilities will be
required.
I look forward to keeping you updated on our endeavors to
advance Sigyn Therapy.
Sincerely,
Jim Joyce
Chairman and CEO
Sigyn Therapeutics, Inc.
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) the outcome of any legal
proceedings that may be instituted against Sigyn related to the
merger agreement or the transaction. Further risks that could cause
actual results to differ materially from those matters expressed in
or implied by such forward-looking statements are discussed in
“Risk Factors” and elsewhere in the previous Reign Resources
Corporation Quarterly Report on Form 10-Q for the quarter ended
June 30, 2020 and other reports filed with the SEC. 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
jimjoyce@elevatescience.com
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