Therapeutic Solutions International Initiates 500 Volunteer COVID-19 Prevention Clinical Trial Using QuadraMune™
June 08 2020 - 9:00AM
InvestorsHub NewsWire
Therapeutic Solutions International Initiates 500 Volunteer
COVID-19 Prevention Clinical Trial Using QuadraMune™
San
Diego Top Doctor James Veltmeyer Leads Efforts to Demonstrate
Efficacy of Immune Boosting Formulation in High-Risk
Population
OCEANSIDE, CA -- June
8, 2020 -- InvestorsHub NewsWire -- Therapeutics
Solutions International, Inc., (OTC
Markets:
TSOI) announced
the
initiation of a
clinical trial aimed at demonstrating safety and efficacy of its
immune-boosting formulation QuadraMune™.
The trial is
anticipated to recruit 500 subjects at risk of SARS-CoV-2
infection, the type of coronavirus which causes
COVID-19.
The new clinical
trial has been granted ClinicalTrials.gov Identifier: NCT04421391
and is expected to appear on the Federal Clinical Trial registry
this week.
Last week the Company
announced data from a preliminary clinical trial in which four
groups of eight volunteers were treated with placebo or escalating
doses of QuadraMune™ [1].
Elevation of innate immune response activity was observed, together
with a decreased responsiveness towards inflammatory stimuli.
These preliminary data were analyzed by the Company's Scientific
Advisory Board, who then
recommended
proceeding to the larger trial.
"At Therapeutic
Solutions International we believe only in hard science. As a
medical doctor who is on the frontlines of the war with
Coronavirus, I and my staff take QuadraMune™ daily"
said James Veltmeyer,
Chief Medical Officer of Therapeutic Solutions International and
"Top Doctor" of San Diego in 2012, 2014, 2016, 2017, and 2019. "The
laboratory and early clinical results seen with QuadraMune™ are
truly inspiring. We believe the time has come to jump into a
large clinical trial to generate the data necessary
to
truly
convince our colleagues and the world of the potential efficacy of
this immune-stimulatory and anti-inflammatory approach."
The clinical trial
calls for the daily administration of QuadraMune™ for a period of
twelve weeks. Rates of infection will be assessed compared to
controls. Subjects eligible to enter the trial are high-risk
individuals, which
are
defined as all health care workers in hospitals, clinics, and
emergency rooms, and medical facilities.
"If you look
historically at pandemics, almost all of them have a Second Wave,
which is almost always substantially more devastating
than the
first. We at
Therapeutic Solutions International are pleased to apply our work
in the area of inflammation and immune stimulation, to attempt to
add another arrow in our quiver against this invisible
enemy" said Timothy Dixon,
President, and CEO of Therapeutic Solutions International. "In some
ways, Coronavirus is like cancer…you want to increase activation of
innate immunity and
suppress
inflammatory reactions simultaneously.
We have been doing this research successfully
using
NanoStilbene™ in cancer, and now
we
are
transposing our findings into the field of virology."
A pre-publication
copy, of the submitted
manuscript of the preliminary
clinical trial, is available by
following this link: https://therapeuticsolutionsint.com/CV/JTRM-D-20-01014.pdf
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] https://www.biospace.com/article/releases/therapeutic-solutions-international-announces-positive-preclinical-and-clinical-evaluation-of-nutritional-supplement-quadramune-designed-to-protect-against-covid-19/
Therapeutic Solutions
International, Inc.
ir@tsoimail.com
- Company Initiates 500 Volunteer COVID-19
Prevention Clinical Trial Using QuadraMune™
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