Therapeutic Solutions International
Leverages Filed and Issued Intellectual Property to
Develop COVID-19 Nutraceutical Candidate:
QuadraMune™
Company Intends to Initiate
Clinical Trials using Novel "Multipronged" Attack on Coronavirus
Pathology
OCEANSIDE, CA -- May
5, 2020 -- InvestorsHub NewsWire -- Therapeutics
Solutions International, Inc., (OTC
Markets:
TSOI) announced the
filing of
a patent application
covering QuadraMune™, a
nutraceutical developed to address issues of susceptibility,
inflammation, and viral immunity, for COVID-19
patients.
Initial work on
QuadraMune™ was based on patent application 62/735867, filed Sept
25, 2018, which disclosed uses of
pterostilbene to treat cytokine
release syndrome in a variety of conditions including severe acute
respiratory syndrome (SARS) and acute respiratory
distress syndrome (ARDS). Furthermore,
issued patent #9,682,047 described the
use of
pterostilbene to decrease neutrophil activation in cancer
patients.
"Given the
fundamental role of unrestrained inflammation
[1], as well as
pulmonary and systemic neutrophil activation in COVID19
patients
[2], we sought to
leverage the potential of this molecule to address the current
pandemic," said
Thomas
Ichim, Ph.D., Board Member
of TSOI and
co-inventor
of the patent. "We decided to expand our work by applying a
multi-angled
nutraceutical solution that addressed various aspects of
COVID-19. For example, at the beginning of the disease
process, the body's susceptibility to infection with the SARS-CoV-2
virus is a major determining factor as to progression of the
disease. Belonging to the coronavirus family of viruses, it
is well recognized that natural killer cells and interferon
responses play a role in host susceptibility
[3]."
The role of
inflammatory cytokines in the progression of ARDS and its pathology
may be seen in several situations. For example, tumor
necrosis factor (TNF) –alpha, has been demonstrated to correlate
with the severity of ARDS in several studies
[4].
Ingredients in
QuadraMune such as pterostilbene
[5],
sulforaphane
[6],
and thymoquinone [7]
have been
shown to inhibit TNF-alpha by independent investigators.
Another cytokine that
has been studied extensively in ARDS is interleukin-6.
This cytokine is known to possess pro-inflammatory properties, as
well as to suppress the generation of T regulatory cells and
promote Th17 cells. It is accepted that in ARDS there is a
reduction in T regulatory cells, whose role is tissue protection,
and Th17 cells, which are commonly associated with
inflammation [8].
"We have demonstrated
the pterostilbene administered in the form of NanoStilbene in
cancer patients results in increased NK cell activity, as well as
interferon-gamma production. Additionally, pterostilbene has
shown to inhibit inflammatory cytokines associated with
ARDS" said Dr. James
Veltmeyer, Chief Medical Officer of TSOI. "For example, studies
have demonstrated inhibition of interleukin-1, interleukin-6,
interleukin-8, and TNF-alpha, by pterostilbene".
"QuadraMune, as the
name applies, consists of four unique ingredients that in tandem
provide synergism in reducing inflammation," said Tim Dixon,
President, and CEO of TSOI and co-inventor of
the patent.
"We
have of course included pterostilbene, a very potent inhibitor of
inflammatory molecules, along with sulforaphane, a phase II detox
promoter which also protects lungs from damage by activating the
Nrf2 gene [9],
EGCg (epigallocatechin gallate), extracted from green tea that can
stimulate T cells [10],
inhibit pathological immunity [11],
and also protect the lungs, and thymoquinone which comes from the
plant nigella sativa that suppresses autophagy, potential antiviral
mechanistic effects on cells [12],
and has been demonstrated to stimulate NK cells [13]
which are
antiviral."
About
Therapeutic Solutions International, Inc.
Therapeutic Solutions
International is focused on immune modulation for the treatment of
several specific diseases. Immune modulation refers to the ability
to upregulate (make more active) or downregulate (make less active)
one's immune system. The Company's corporate website is at
www.therapeuticsolutionsint.com
and our
e-commerce is at www.youcanordernow.com and for additional
info on QuadraMune™
visit www.areyoucovidmune.com/covidmune/.
These statements have
not been evaluated by the Food and Drug Administration. These
products are not intended to diagnose, treat, cure, or prevent any
disease.
[1]
Liu et
al. Longitudinal characteristics of lymphocyte responses and
cytokine profiles in the peripheral blood of SARS-CoV-2 infected
patients. EBioMedicine.
2020 Apr 18;55:102763.
[2]
Zuo
et al.
Neutrophil extracellular traps in COVID-19. JCI Insight. 2020 Apr
24. pii:
138999
[3]
Yaqinuddin
et al.
Innate immunity in COVID-19 patients mediated by NKG2A receptors,
and potential treatment using Monalizumab,
Cholroquine,
and antiviral agents. Med Hypotheses. 2020 Apr 22;140:109777.
[4]
Li et al.
Risk factors for severity and mortality in adult COVID-19
inpatients in Wuhan. J Allergy Clin Immunol. 2020 Apr 12.
pii:
S0091-6749(20)30495-4.
[5]
Hsu et
al. The inhibitory effect of pterostilbene on inflammatory
responses during the interaction of 3T3-L1 adipocytes and RAW 264.7
macrophages. J Agric Food Chem. 2013 Jan
23;61(3):602-10.
[6]
Liu et
al. Biomarker Exploration in Human Peripheral Blood Mononuclear
Cells for Monitoring Sulforaphane Treatment Responses in Autism
Spectrum Disorder. Sci Rep. 2020 Apr 2;10(1):5822
[7]
Akter
et al.
Targeting inflammatory mediators: An anticancer mechanism of
thymoquinone action. Curr
Med Chem.
2019 Oct 11.
[8]
Toyama et
al. Attenuated accumulation of regulatory T cells and reduced
production of interleukin 10 lead to the exacerbation of tissue
injury in a mouse model of acute respiratory distress syndrome.
Microbiol Immunol. 2018 Feb;62(2):111-123
[9]
Qi et al.
Sulforaphane exerts anti-inflammatory effects against
lipopolysaccharide-induced acute lung injury in mice through the
Nrf2/ARE pathway. Int J Mol Med. 2016 Jan;37(1):182-8.
[10]
Rawangkan
et al.
Green Tea Catechin Is an Alternative Immune Checkpoint Inhibitor
that Inhibits PD-L1 Expression and Lung Tumor Growth. Molecules.
2018 Aug 18;23(8). pii:
E2071
[11]
Wheeler
et al. The green tea polyphenol epigallocatechin-3-gallate improves
systemic hemodynamics and survival in rodent models of
polymicrobial sepsis. Shock. 2007 Sep;28(3):353-9.
[12]
https://chemrxiv.org/articles/Identification_of_Compounds_from_Nigella_Sativa_as_New_Potential_Inhibitors_of_2019_Novel_Coronasvirus_Covid-19_Molecular_Docking_Study_/12055716
[13]
Majdalawieh
et al.
Immunomodulatory and anti-inflammatory action of Nigella sativa and
thymoquinone: A comprehensive review. Int Immunopharmacol.
2015 Sep;28(1):295-304.
Safe Harbor
Statement
This
release contains forward-looking statements that are based upon
current expectations or beliefs, as well as a number of assumptions
about future events. Although we believe that the expectations
reflected in the forward-looking statements and the assumptions
upon which they are based are reasonable, we can give no assurance
that such expectations and assumptions will prove to have been
correct. Forward-looking statements are generally identifiable by
the use of words like "may," "will," "should," "could," "expect,"
"anticipate," "estimate," "believe," "intend," or "project" or the
negative of these words or other variations on these words or
comparable terminology. The reader is cautioned not to put undue
reliance on these forward-looking statements, as these statements
are subject to numerous risk factors as set forth in our SEC
filings. To the extent that statements in this press release are
not strictly historical, including statements as to product launch
timing, revenue projections, business strategy, outlook,
objectives, future milestones, plans, intentions, goals, future
collaboration agreements, or otherwise as to future events, such
statements are forward-looking, and are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. The forward-looking statements contained in this release
are subject to certain risks and uncertainties that could cause
actual results to differ materially from the statements
made.
Contact
Information:
- Therapeutic Solutions
International, Inc.
ir@tsoimail.com
- New Patent Filing Based on Stimulation of Immunity While
Suppressing Inflammation
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