#TherapeuticTechnology #Stock Sigyn
Therapeutics (OTC: $SIGY) CEO Note: Rethinking the Treatment of Sepsis and
Other Life-Threatening Inflammatory Conditions; #COVID19 #CytokineStorm @Sigyn_inc
SAN DIEGO, November 2, 2020 / Investorideas.com Newswire – Therapeutic technology stock news - Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), today released the following note authored by its Chairman and CEO, Jim Joyce.
Read this news,
featuring SIGY in full at https://www.investorideas.com/news/2020/biotech/11021OTC-SIGY.asp
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
Paid
News -Disclaimer/Disclosure: Investorideas.com is a
digital publisher of third party sourced news, articles and equity research as
well as creates original content, including video, interviews and articles.
Original content created by investorideas is protected by copyright laws other
than syndication rights. Our site does not make recommendations for purchases
or sale of stocks, services or products. Nothing on our sites should be
construed as an offer or solicitation to buy or sell products or securities.
All investment involves risk and possible loss of investment. This site is
currently compensated for news publication and distribution, social media and marketing,
content creation and more. Contact each company directly regarding content and
press release questions. Disclosure is posted for each compensated news
release, content published /created if required but otherwise the news was not
compensated for and was published for the sole interest of our readers and
followers. Disclosure : this news release featuring Sigyn
Therapeutics, Inc. (OTCMarkets: SIGY), is a paid for service
on Investorideas.com . More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our
other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com
Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp
About
Investorideas.com
https://www.investorideas.com/About/
Sign up for free
stock news alerts at Investorideas.com
https://www.investorideas.com/Resources/Newsletter.asp
BiotechIndustryStocks.com
- investing ideas in biotechnology stocks, medical technology, telemedicine,
Covid-19
Like Biotech Stocks? View our Biotech Stocks Directory
Get News Alerts on
Biotech Stocks
