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Monday, 05/20/2019 8:34:17 AM

Monday, May 20, 2019 8:34:17 AM

Post# of 64318
TSOI DD / NEWS / SS

Therapeutic Solutions International is focused on immune modulation
for the treatment of several specific diseases

http://therapeuticsolutionsint.com/

On the Right To Try Pathway for Treatment, Prevention, or Treatment and Prevention of :


Stage 1 - 4 Cancers (Tumor types), w/ StemVacs Dendritic Cell Vaccine / Immunotherapy Platform, and NanoStilbeneTM
CTE - (Chronic Traumatic Encephalopathy) w/ JadiCell MSCs - (Mesenchymal Stem Cells), Autologous Neurogenic Stem Cell Banking, sRNA augmented stem cells, "Educated" Monocytes / Progenitors, and NeuroStilbene
TBI / mTBI - (Traumatic Brain Injury / mild TBI) w/ JadiCell MSCs - (Mesenchymal Stem Cells), and NeuroStilbene
CRS - (Cytokine Release Syndrome) / Inflammation w/ NanoStilbeneTM

FDA Right to Try info for patients
https://www.fda.gov/ForPatients/Other/ucm625115.htm

The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018. This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial to access certain unapproved treatments.

The Right to Try Act permits/allows eligible patients to have access to eligible investigational drugs.

An eligible patient is a patient who has:

Been diagnosed with a life-threatening disease or condition
Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
And has provided, or their legally authorized representative has provided written informed consent regarding the eligible investigational drug to the treating physician

An eligible investigational drug is an investigational drug:

For which a Phase 1 clinical trial has been completed
That has not been approved or licensed by the FDA for any use
For which an application has been filed with the FDA or is under investigation in a clinical trial that is intended to form the primary basis of a claim of effectiveness in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
Whose active development or production is ongoing, and that has not been discontinued by the manufacturer or placed on clinical hold by the FDA


Who is in charge of pre-approval access decisions ?
https://med.nyu.edu/pophealth/divisions/medical-ethics/compassionate-use

The companies developing new medical products are the key decision-makers in determining whether to provide access to their investigational medical products. This is the case for both expanded access and right to try. Furthermore, companies that are willing to provide investigational products get to decide which pathway they’ll use. For example, a physician may seek access to a drug via right to try, but the company may inform the physician that it will provide it only via expanded access pathway, or vice versa.


In expanded access and right to try, the patient must provide informed consent; however, the consent document is not held to the same standards in right to try and expanded access. (For example, federal law requires that informed consent documents used in expanded access detail a patient’s rights; right to try has no such requirement.)

Finally, right to try includes a liability provision that shields all parties involved in the use of an investigational product in a therapeutic attempt from lawsuits in most instances; the FDA’s expanded access pathway does not.

In right to try, a physician requests an investigational drug from a company, providing information about the patient who would receive it. If a company agrees to provide it, no FDA or IRB approval is required (unless the facility where the product will be administered requires IRB review).

Currently, CUPA is aware of only one company that has opted to make its products available via right to try. Therapeutic Solutions International, Inc. has indicated its willingness to provide a post–Phase I stem cell immunotherapy product to oncology patients.

TSOI CEO Tim G Dixon receiving the Right To Try Leadership Award
(Video) 12/19/18
https://www.facebook.com/tsoihome/videos/2083466298358398/

Therapeutic Solutions International Announces the Appointment of
James Veltmeyer, MD as Chief Medical Officer

https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/77684969/therapeutic-solutions-international-announces-the

Oceanside, CA -- June 18, 2018 -- InvestorsHub NewsWire -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) previously announced their plans to provide access to its clinical stage cancer immunotherapy product StemVacs under the Right To Try law signed by President Trump on May 30th 2018, and have appointed Dr. James Veltmeyer as Chief Medical Officer of their future planned cancer clinic.

"Having Dr. Veltmeyer head up our future "Right To Try Cancer Clinic", as well as all other clinical programs underway is a dream come true for TSOI," said Timothy Dixon, President, and CEO of Therapeutic Solutions International. "In his role as Chief of the Department of Family Medicine at Sharp Grossmont Hospital, where he currently provides senior leadership to over 200 physicians, Dr. Veltmeyer has developed skills that few ever do, allowing him to bring a wealth of experience in management and medicine to bear on our programs.


TSOI Products

8 Biologics, 10 Nutraceuticals, 1 Pharmaceutical = 19


8 Biologics
innaMune http://www.marketwired.com/press-release/therapeutic-solutions-files-patent-on-blood-derived-innate-immune-system-stimulator-otc-pink-tsoi-2216672.htm
MemoryMune http://www.marketwired.com/press-release/therapeutic-solutions-files-patent-on-methods-re-activating-dormant-memory-cells-with-otc-pink-tsoi-2220094.htm
StemVacs http://stemvacs.com/
BRS-001 http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/77635806/therapeutic-solutions-international-expands-adopti
sRNA augmented stem cells http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/78834511/therapeutic-solutions-international-expands-chroni
JadiCell MSCs https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/78853508/therapeutic-solutions-international-signs-agreemen
Autologous Neurogenic Stem Cell banking http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79022244/therapeutic-solutions-international-continues-to-e
"Educated" Monocytes / Projenitors https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79095195/therapeutic-solutions-international-continues-to-e

10 Nutraceuticals
Projuvenol http://projuvenol.com/
NanoStilbene http://nanostilbene.com/
DermalStilbene http://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/77477228/therapeutic-solutions-international-releases-derm
IsoStilbene https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/77734511/therapeutic-solutions-international-releases-isos
NeuroStilbene https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/77868683/therapeutic-solutions-international-inc-release
Alpha Lipoic Acid https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/78013140/therapeutic-solutions-international-develops-micro
Cancer Metabolic DeTox http://www.marketwired.com/press-release/therapeutic-solutions-files-new-patent-on-targeting-tumor-microenvironment-through-nutraceutical-otc-pink-tsoi-2215015.htm

3 New Products distributed in Mexico under the Immun ET Label
Nano Cannabidiol
NanoVita
NanoVita Plus

https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79840011/therapeutic-solutions-international-awards-distrib

1 Pharmaceutical
LymphoBoost http://www.marketwired.com/press-release/therapeutic-solutions-files-new-patent-on-augmentation-anti-tumor-immunity-mifepristone-otc-pink-tsoi-2217703.htm


4 nutraceutical products for sale online
Projuvenol, NanoStilbene, DermalStilbene
(x2)
http://www.youcanordernow.com/

4 Biologics, 3 Nutraceuticals, 1 Pharmaceutical licensed to Pan Am Cancer Treatment Center in Mexico
StemVacs, innaMune, MemoryMune, BRS-001, Cancer Metabolic DeTox, NanoStilbene, IsoStilbene, LymphoBoost


http://ih.advfn.com/p.php?pid=nmona&article=77606645
http://ih.advfn.com/p.php?pid=nmona&article=77309980
http://ih.advfn.com/p.php?pid=nmona&article=77635806
https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/77734511/therapeutic-solutions-international-releases-isos

Pan Am Cancer Treatment Center Introductory Tour Video
https://www.youtube.com/watch?v=rWgJLRCICa8&feature=youtu.be

TSOI Products in Development


https://www.facebook.com/tsoihome/ (description under new TSOI lab photos)

Look for many new exciting specialty products to come from these facilities
including combination compounds such as pterostilbene and cannabidiol, pterostilbene and alpha-lipoic-acid, pterostilbene and huperzine, all in nanoparticle formulations
.

TSOI Patents
http://therapeuticsolutionsint.com/?page_id=68
TSOI Patent Search
https://patents.google.com/?assignee=Therapeutic+Solutions+International+Inc

TSOI Scientific Advisory Board Members
https://therapeuticsolutionsint.com/?page_id=64

NEWS 5/6/19

Therapeutic Solutions International Awards Distribution of NanoStilbene and Nano Cannabidiol in Mexico to Immun ET Laboratories, LLC.

NanoStilbene Shown to Enhance Anticancer Immunity in Cancer Patients through Modulation of Inflammatory Mediators
https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79840011/therapeutic-solutions-international-awards-distrib

OCEANSIDE, CA -- May 6, 2019 -- InvestorsHub NewsWire -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) announced today a sales agreement for the exclusive distribution of NanoStilbene and Nano Cannabidiol throughout Mexico with Immun ET.

TSOI recently announced preliminary data for immune stimulation in advanced cancer patients with NanoStilbene, a nanoemulsion of nanoparticle pterostilbene that is taken orally. Daily treatment with NanoStilbene caused a reduction in serum levels of inflammatory markers TNF-alpha, IL-6, and CRP. Assessment of peripheral blood mononuclear cell ability to generate IFN-gamma subsequent to stimulation with anti-CD3 and anti-CD28 was increased. Additionally, NK cytotoxicity was augmented.

These results suggest that NanoStilbene may be a useful adjuvant to immunotherapy of cancer rescuing T cell and NK cell activities. Augmentation of NK cell function may stimulate efficacy of approved therapies that depend on an active NK compartment such as Herceptin, Rituximab, and Cetuximab.

The Nano Cannabidiol product we have produced is built upon the same nano particle platform as NanoStilbene. This provides for good protection and oral delivery system, the nanoemulsion for cannabidiol isolate uses the same low-energy emulsification method as NanoStilbene. Nanoemulsions are non-equilibrium systems and possess kinetic stability in a long period with a remarkable small droplet size (below 200 nm).

The cannabidiol isolate (which contains zero THC, and zero Terpenes) we place in the nanodroplet is free from air, light, and hard environment and contains 200mg of >99% pure isolate per milliliter of liquid. Typical clinical doses of cannabidiol are in the range of 15-20mg daily. 2 drops of our Nano Cannabidiol provides 20mg.

"We are pleased to make this announcement today for Immun ET Laboratories to have exclusive distribution rights for NanoStilbene and Nano Cannabidiol throughout all of Mexico" said Tim G Dixon CEO & President of Therapeutic Solutions International, Inc. "Having worked closely with the principal of Immun ET, Dr. Javier Lopez, for many years in advanced cancer studies where in 2015 we conducted our 10 patient StemVacs immunotherapy clinical trial, we are excited to continue our long-standing relationship further solidified by this award announced today."

"Immun ET is very excited to offer both of these nano particle compounds from TSOI to our customers in both their original form and in various blends together we are calling NanoVita and NanoVita Plus. Having the privilege to observe all of the work in developing NanoStilbene, essentially from bench to bedside, including a pharmacokinetic study and a clinical trial of advanced cancer patients, we have eagerly awaited this day to be able to provide this patented immune adjuvant to cancer patients in Mexico" said Dr. Javier Lopez, Chief Executive Officer of Immun ET Laboratories. "And in addition, having the ability to distribute exclusively their Nano Cannabidiol in Mexico as well, gives us two very potent and highly concentrated formulations to meet a variety of clinical needs" added Dr. Lopez.


NEWS 2/19/19

Therapeutic Solutions International Continues to Refine NanoStilbene™ Formulation

NanoStilbene Shown to Reduce Tumor Necrosis Factor-a (TNF-a ) in Cancer Patients

https://ih.advfn.com/stock-market/USOTC/therapeutic-solutions-international-inc-pc-TSOI/stock-news/79295986/therapeutic-solutions-international-continues-to-r

OCEANSIDE, CA -- February 19, 2019 -- InvestorsHub NewsWire -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) announced today further refinement of their patented formulation of nanoparticle pterostilbene known as NanoStilbene™.

NanoStilbene™ is a nanoemulsion of nanoparticle pterostilbene in the 75-90nm (nanometer) range at a concentration of 200mg per milliliter. We have successfully produced the same stable nanoemulsion using peach kernel extract to fortify the NanoStilbene against tumor necrosis factor-a (TNF-a ).

"We recently announced the conclusion of a clinical trial involving 12 advanced, solid tumor, cancer patients who received the equivalence of 300mg's of nanoparticle pterostilbene daily for three weeks which showed on average a 26% decrease in TNF-a 1," said Tim G Dixon CEO & President of Therapeutic Solutions International, Inc. "By adding peach kernel extract to our nanoemulsion formulation we intend to fortify NanoStilbene to be even more effective against high levels of inflammatory cytokines."

"In a recent paper, peach kernel extract has been shown to reduce tissue factor (TF) elevations in atherosclerosis, which is a pathological process in arteries due to plaque formation, by first reducing tumor necrosis factor-a (TNF-a)2," said Dr. Thomas Ichim, Director of Therapeutic Solutions International. "Tumor necrosis factor (TNF) is a type of messenger protein known as a cytokine that is produced by white blood cells. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal" added Dr. Ichim.

"By adding the peach kernel extract to the nanoemulsion formulation, our purpose is to open the way for new therapeutic approaches that might eventually decrease the prevalence of tumor necrosis factor-a (TNF-a) in not only cancer patients where TNF-a has been shown to play a key role in these inflammatory processes but also in acute and chronic inflammatory conditions such as trauma, sepsis, infection, rheumatoid arthritis, atherosclerosis, and cardiovascular disease" said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International.

TNF-a is a member of a growing family of peptide mediators comprising at least 19 cytokines, including lymphotoxin-, Fas ligand, and CD40 ligand. TNF-a has important proinflammatory properties, which play crucial roles in the innate and adaptive immunity, cell proliferation, and apoptotic processes. The cytokine is produced by different kind of cells, including macrophages, monocytes, T-cells, smooth muscle cells, adipocytes, and fibroblasts.


TSOI NEWS HISTORY 5/1/18 - 1/22/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146277441


SHARE STRUCTURE
https://www.otcmarkets.com/stock/TSOI/security

AS - 2.5 B common , 5 M preferred - https://www.nvsos.gov/SOSEntitySearch/CorpDetails.aspx?lx8nvq=LvtIoYTPV6wB1RIovm008A%253d%253d&nt7=0
OS - 1,101,102,071
Restricted - 899,619,214
Unrestricted - 201,482,857
Held at DTC - 168,729,857
Float - 105,109,529


SEC Filings https://www.sec.gov/cgi-bin/browse-edgar?company=therapeutic+solutions+international&match=contains&action=getcompany

TA
New Horizon Transfer Inc.
215-515 West Pender Street
Vancouver, BC V6B 6H5
CAN(604) 876-5526
http://newhorizontransfer.com/

TSOI Management / Board of Directors
https://therapeuticsolutionsint.com/?page_id=62

Contact

Investor Relations
ir@tsoimail.com
Corporate Website
http://therapeuticsolutionsint.com/
Additional info
http://projuvenol.com/
https://nanostilbene.com/
https://stemvacs.com/
E Commerce Sites
http://www.youcanordernow.com/
http://immhealth.com/?route=common/home&home_id=44
TSOI Facebook
https://www.facebook.com/tsoihome/
TSOI Twitter
https://twitter.com/tsoisupplement
https://twitter.com/search?f=tweets&vertical=default&q=%24TSOI&src=typd

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