Therapeutic Solutions International Announces Intention to Use Clinical Stage NK Activating Cancer Immunotherapy
June 22 2020 - 9:00AM
InvestorsHub NewsWire
Therapeutic Solutions International Announces Intention to
Use Clinical Stage NK Activating Cancer Immunotherapy
for COVID-19
Company Files Patent on FDA-Pending StemVacs™ Dendritic Cell
Therapy
for Boosting of COVID-19 Immunity
OCEANSIDE, CA -- June
22, 2020 -- InvestorsHub NewsWire -- Therapeutics
Solutions International, Inc., (OTC
Markets:
TSOI) announced today plans to
utilize its clinical-stage cancer immunotherapy StemVacs™ for
treatment of COVID-19 patients.
Previously the Company has
filed data with the FDA, as part of IND #17448, which demonstrated
that treatment of cancer patients with StemVacs™ resulted in
enhanced activity of a type of immunological cell called "natural
killer" cells, otherwise known as "NK cells [1]".
NK cells have been published to
inhibit SARS-CoV-2, the virus which causes COVID-19
[2]. More importantly,
companies such as Celularity have been cleared by the FDA to
administer pre-made NK cells for the treatment of COVID-19 as part
of clinical trials [3].
"We are very excited by the
potential of us offering to COVID-19 patients a new cellular
therapy which has already demonstrated safety and
immune-stimulating activity in a small 10 patient trial in cancer,"
said Dr. James Veltmeyer, Chief Medical Officer of the Company.
"Dendritic cell-based therapies have been proven safe for over a
decade and various companies have FDA clearance for clinical trials
using these cells, including one company, Dendreon, which has obtained marketing
approval [4]. In contrast to previous
dendritic cell approaches, StemVacs uses a proprietary means of
"supercharging" the dendritic cells, which we believe makes our
approach uniquely suited for application in virology."
The rationale described in the
patent application and regulatory documents being generated for
potential clinical trials is based on the finding that dendritic
cells instruct the body to generate natural killer cells. The
Company believes that natural killer cells generated by the body
will be more potent than infusions of artificially generated cells
that other approaches are currently utilizing.
"We are very thankful to our
internationally renowned Scientific Advisory Board who pointed out
the advanced stage of our StemVacs™ clinical program, and the
possibility of "repositioning" this cellular therapy for use in
COVID-19," said Timothy Dixon, President, and CEO of the Company.
"Given that the innate immune system is the first line of
protection against viruses, we see our repositioned StemVacs
product as being developed both as stand-alone immunotherapy, as
well as an adjuvant product to enhance the efficacy of stimulators
of the adaptive immune responses."
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.globenewswire.com/news-release/2018/09/04/1564969/0/en/Therapeutic-Solutions-International-Completes-Phase-1-Clinical-Trial-in-Advanced-Cancer-Patients-for-Right-to-Try-Access-of-its-StemVacs-Product-for-American-Cancer-Patients.html
[2]
Mazzoni
et al.
Impaired Immune Cell Cytotoxicity in Severe COVID-19 Is IL-6
Dependent. J Clin Invest. 2020 May 28;138554. https://www.jci.org/articles/view/138554
[3]
https://www.cancernetwork.com/view/fda-accepts-ind-nk-cell-therapy-cynk-001-treat-patients-covid-19
[4]
DeFrancesco. Landmark
Approval for Dendreon's
Cancer
Vaccine. Nat Biotechnol.
2010 Jun;28(6):531-2.
Therapeutic Solutions
International, Inc.
ir@tsoimail.com
- Company Files Patent on FDA-Pending StemVacs™ Dendritic
Cell Therapy for Boosting of COVID-19 Immunity
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