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Therapeutic Solutions International, Inc. (TSOI)

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FDA Health News

NEWS 12/31/20 Therapeutic Solutions International Launches Campbell Neurosciences Inc as First Suicide Focused Regenerative Psychiatry Biotechnology Company

Campbell Neurosciences to License Key Intellectual Property Assets as Clinical Trials of Campbell Score and Kaihani Score are Ongoing

OCEANSIDE, Calif., Dec. 31, 2020 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today the launching of Campbell Neurosciences Inc as a partially owned spin-off from the Company. The new corporation will be led by Ms. Kalina O'Connor as President and Chief Executive Officer, Dr. James Veltmeyer as Chief Medical Officer, and Ms. Jona Barnes as Chief Financial Officer.

Campbell Neurosciences Inc has signed license agreements with Therapeutic Solutions International for access to the 9 patents filed related to the previous Campbell Neurosciences Division. The patents are:

1. 63/128759 Immunotherapy for Opioid Addiction
2. 63/122862 Treatment of Major Depressive Disorder and Suicidal Ideations Through Stimulation of Hippocampal Neurogenesis Utilizing Plant-Based Approaches
3. 63/105964 Protection/Regeneration of Neurological Function by Endothelial Protection/Rejuvenation using Stem Cells for Treatment of Conditions such as Chronic Traumatic Encephalopathy and Schizophrenia
4. 17/030416 Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention
5. 63/077723 Immunotherapy of Schizophrenia and Schizophrenia Associated Suicidal Ideation/Suicide
6. 63/071381 Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline
7. 63/068388 Methods of Determining Risk of Suicide and/or Suicidal Ideation by Immunological Assessment
8. 63/061202 Prevention of Neuroinflammation associated Memory Loss Using Nutraceutical Compositions
9. 63/057315 Neuroprotection and Neuroregeneration by Pterostilbene and Compositions Thereof

Additionally, Campbell Neurosciences Inc. has entered into purchase agreements with Therapeutic Solutions International ensuring a continued supply, at a discounted rate, of nutraceuticals which are being explored for antiinflammation/suicide prevention activity.

"I am honored that the Board of Therapeutic Solutions International has agreed to spin off the Campbell Neurosciences Division as an independent entity," said Kalina O'Connor, Chief Executive Officer of Campbell Neurosciences Inc. "By leveraging the unique relationship between immunology, neurosciences and regenerative medicine, we aim to position ourselves as leaders in establishing a scientific and quantifiable basis to the practice of regenerative psychiatry."

"Having collaborated with Ms. O'Connor in our work at Therapeutic Solutions International, I am pleased to be the Chief Medical Officer of Campbell Neurosciences, a company dedicated to preventing suicide," said Dr. James Veltmeyer. "We are dedicated to demonstrating to the world that suicide is not a choice but a disease."

"Ms. O'Connor approached us with the idea of forming a company named after her mother, Kathleen Campbell, who was a victim of suicide. I was impressed by Ms. O'Connor's deep insight into biology, as well as her unwavering commitment to help other people in her mother's situation," said Timothy Dixon, Chairman, President and CEO of Therapeutic Solutions International. "Having worked with Ms. O'Connor and after meeting certain milestones including establishment of two clinical trials, the board decided that enhanced value can be obtained with Campbell Neurosciences spinning out as a separate entity. We will support Ms. O'Connor and Campbell Neurosciences on an ongoing basis."

NEWS 12/30/20 Therapeutic Solutions International Reports QuadraMune™ Increases T Cell Immunity in Animal Studies

Accumulating Data Supports Possibility of Enhanced Antiviral Immunity Using Nutraceutical Approach

OCEANSIDE, Calif., Dec. 30, 2020 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today new data demonstrating a two-week course of QuadraMune™ increased immunological parameters relevant to antiviral immunity.

In a series of experiments, the Company demonstrated that animals injected with a model antigen, keyhole limpet hemacyanin (KLH) possessed a significantly enhanced T cell response. The type of T cell response that was preferentially elicited in animals taking QuadraMune was associated with interferon gamma, a protein known to inhibit viral replication.

"Previously we have demonstrated that QuadraMune is associated with enhanced natural killer cells, which represent the innate arm of the immune system" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The demonstration that the adaptive immune response is also enhanced by QuadraMune, provides further rationale for evaluation of this nutraceutical as a preventative for COVID-19."

The Company is currently running a clinical trial in health care workers using QuadraMune to prevent COVID-19 infection. More information on the clinical trial can be found on the Federal Clinical Trials registry as #NCT04421391.

"Although there are numerous nutraceutical products on the market that claim to boost immunity, I am extremely proud that we as a company are differentiating ourselves by conducting scientific experiments to objectively validate our approach" said Famela Ramos, Vice President of Business Development.

"Our Company is based on utilizing the immune system to treat numerous chronic and degenerative conditions. Today's findings, that QuadraMune stimulates the Th1 arm of the immune system, suggests that QuadraMune may be useful for other conditions associated with immune dysregulation" said Timothy Dixon, President and CEO of the Company. "It is believed that Th1 immunity is useful not only in the treatment of viruses but also in eradication of cancer and intracellular bacterial." NEWS 12/21/20
Therapeutic Solutions International Files Patent on NeuroLeukin™ Personalized Immunotherapy for Opioid Addiction

Campbell Neurosciences Division Expands its "Regenerative Psychiatry" Approach to Address the $179 Billion Dollar Prescription Opioid Epidemic

OCEANSIDE, Calif., Dec. 21, 2020 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today novel data and filing of a patent covering utilization of its NeuroLeukin™ product for altering molecular pathways associated with opioid addiction. In a series of animal experiments NeuroLeukin™ was demonstrated to reduce activation of TLR-4, which is one of the major innate immune pathways associated with opioid tolerance and addiction1.

It is estimated that the current opioid use epidemic costs the health care system approximately $179 Billion annually2. Campbell Neurosciences, the Company's Division focused on suicide prevention has previously filed intellectual property on utilizing NeuroLeukin™ to reduce suicidal ideations.

"The common biochemical pathways of opioid addiction and suicidal ideation should be no surprise given the inherent relationship between these two conditions," said Dr. James Veltmeyer, Chief Medical Officer of the Company and co-inventor of the patent. "Currently we have 2 clinical trials on the Federal ClinicalTrials.gov website dealing with immunological quantification of psychiatric disorders: suicide and gambling. We are excited to take NeuroLeukin™ into the clinic, which to my knowledge represents the first immunotherapeutic approach for opioid addiction."

"Immunotherapy, which at one point was considered on the fringe of medicine, has blossomed into what is expected to be a 126-billion-dollar annual market in 20263, given its recent successes in the treatment of cancer," said Famela Ramos, Vice President of Business Development and co-inventor of the patent. "We are excited to position ourselves as the potential leaders in applying immunotherapy to mental disorders, an approach that we like to call "regenerative psychiatry."

"Having seen many close friends of mine suffer the horrible effects of opioid addiction, I am proud to be co-inventor on an approach which has the potential to revolutionize the way drug addiction is seen by the medical community," said Wais Kaihani, consultant to the Company.

"I am thankful for our internationally renowned scientific advisory board, which is comprised of immunologists and neurobiologists, that have stimulated our Company to enter such an unexplored space in which very little therapeutic interventions exist," said Timothy Dixon, President and CEO of the Company and co-inventor. "We are 100% dedicated to ending the opioid crisis or catalyzing development of novel approaches to accelerate an end to this tragic and avoidable loss of life."

1 Discovery of a Novel Site of Opioid Action at the Innate Immune Pattern-Recognition Receptor TLR4 and its Role in Addiction - ScienceDirect
2 What Are The Real Costs Of The Opioid Epidemic? : Shots - Health News : NPR
3 Cancer Immunotherapy Market Worth $126.9 Billion By 2026 (grandviewresearch.com)

NEWS 12/17/20
Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell® Universal Donor Stem Cell

OCEANSIDE, Calif., Dec. 17, 2020 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells™.

The JadiCell is a type of umbilical cord derived mesenchymal stem cell which possesses superior therapeutic activity as compared to other stem cell types based on laboratory and clinical studies. The JadiCell was recently reported to possess therapeutic activity against COVID-19 in a recently published clinical trial1. The Company previously obtained an exclusive license for use of JadiCells for CTE and Traumatic Brain Injury (TBI)2,3.

"My team and myself are extremely excited about the potential of using our unique novel cell therapy for treatment of CTE, which is the cause of countless deaths, as well as chronic disabilities" said Dr. Amit Patel, inventor of the JadiCell. "Having worked over the past several years with the multidisciplinary team assembled by Timothy Dixon, I look forward to progress in this area of medicine, for which currently there are limited options."

Chronic Traumatic Encephalopathy (CTE) is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players4. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells.

Suicide is a major cause of death in military veterans, approximately 20 deaths per day5. It is widely known that TBI and CTE are associated with increased propensity for suicide6,7. Furthermore, studies show that cytokines associated with brain inflammation, such as IL-6 and TNF-alpha are found in higher levels in patients with suicidal tendencies8.

"To our knowledge, this is the first therapeutic intervention addressing CTE using stem cells and we are tremendously excited to finally move into clinical testing for this terrible disease that not only affects athletes but our military and law enforcement as well" said Timothy Dixon, President and CEO of the Company. "Having worked over the last 2 years in developing the preclinical data supporting this IND, we are extremely pleased to file this new drug application today."

1 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3696875

2 https://www.globenewswire.com/news-release/2019/07/01/1876699/0/en/Therapeutic-Solutions-International-2Obtains-Exclusive-License-for-Patented-Clinical-Stage-Adult-Stem-Cell-for-Treatment-of-Military-and-Sports-Brain-Injuries.html

3 https://patents.google.com/patent/US9803176?oq=9803176

4 https://www.nytimes.com/interactive/2017/07/25/sports/football/nfl-cte.html

5 https://en.wikipedia.org/wiki/United_States_military_veteran_suicide

6 https://www.psychcongress.com/news/traumatic-brain-injury-tied-increased-risk-suicide

7 https://sbindependent.org/nfl-athletes-with-cte-who-committed-suicide/

8 https://www.ncbi.nlm.nih.gov/pubmed/20951793

NEWS 12/16/20
Therapeutic Solutions International Signs Letter of Intent with Premier Adipose Stem Cell Company Synova Life Sciences to File IND for Suicide Prevention
Campbell Neurosciences Division Aims to Combat Suicide-Causing Brain Inflammation using Stromal Vascular Fraction Immunotherapy

OCEANSIDE, Calif., Dec. 16, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today signing a letter of intent with Synova Life Sciences aimed at developing a "First in Class" cellular therapy for suicide and suicidal ideation.

Under the proposed collaboration, Therapeutic Solutions International will contribute its existing expertise and intellectual property regarding adipose stem cell treatment of neuroinflammatory disorders, whereas Synova Life Sciences will provide access to its non-enzymatic stromal vascular fraction isolation device.

The two parties aim to file an Investigational New Drug (IND) application to the FDA for initiating a clinical trial in patients at high risk of suicide.

"Numerous publications have supported potent anti-inflammatory activity of stromal vascular fraction (SVF) cells 1, 2, which are rich not only in mesenchymal stem cells, but also in T regulatory cells, type 2 monocytes, and endothelial progenitor cells3," said Kalina O'Connor, Director of the Company's Campbell Neurosciences, which is focused on Suicide Prevention. "We are highly impressed by the superior speed, viability, and quality of SVF cells obtained using the Synova Life Sciences device as compared to other collagenase-based approaches. Based on this, we are eager to initiate collaborations in leveraging this device to extract the cellular fractions which we hope will be useful in reducing suicidal ideations and suicide."

"I look forward at working with the Team at Therapeutic Solutions International in advancing this novel utility of adipose derived stem cells," said John Chi, President and CEO of Synova Life Sciences. "Through collaboration with cutting edge innovators, we believe we will obtain greatest shareholder value while accelerating the progress of medicine."

"To our knowledge the Synova Device not only provides the highest quality cells, but also accomplishes this is in more rapid time than compared to other devices," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "The rapid development and track record of success possessed by the team at Synova, makes them ideal partners for us as we enter this brave new world of regenerative psychiatry."

1 Bowels et al. Immunomodulatory Effects of Adipose Stromal Vascular Fraction Cells Promote Alternative Activation Macrophages to Repair Tissue Damage. Stem Cells. 2017 Oct;35(10):2198-2207.
2 Riordan et al. Non-expanded adipose stromal vascular fraction cell therapy for multiple sclerosis. J Transl Med. 2009 Apr 24;7:29.
3 Mizer et al. Exogenous endothelial cells as accelerators of hematopoietic reconstitution. J Transl Med . 2012 Nov 21;10:231.

NEWS 12/9/20
Therapeutic Solutions International Division of Campbell Neurosciences Files Patent on QuadraMune™ for Treatment of Major Depressive Disorder

Preclinical Data Suggests QuadraMune™ Prevents Stress-Induced Suppression of Neurogenesis More Effectively than Prozac

OCEANSIDE, Calif., Dec. 9, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today new data suggesting the possibility that QuadraMune™ may mediate neuroprotective activity through preserving the ability of regenerative brain cells to proliferate subsequent to psychological stress.

The experiments, which involved exposing mice to established stressors, demonstrated that specific areas of the brain associated with production of new brain cells are damaged by stress.  In agreement with previously published research, administration of fluoxetine (Prozac™) protected the brain from stress-induced damage.  Surprisingly, QuadraMune™ administration appeared superior to Prozac™ at stimulating proliferation of new brain cells. 

"QuadraMune™ which is currently in a clinical trial for prevention of COVD-191, has also been demonstrated to possess anti-inflammatory activity in other clinical trials, suppressing cytokines such as IL-62, which are known to be involved in depression3 and suicide4" said Kalina O'Connor, Director of Campbell Neurosciences and co-inventor on the patent.  "Given major depressive disorder causes a significant risk for suicide, we are highly interested in exploring the use of QuadraMune™ for preventing suicide."

"Although much enthusiasm has been generated over the planned distribution of the COVID vaccine, at present little is being done to address mental health issues that are being exacerbated by the current pandemic" said Dr. James Veltmeyer, co-inventor of the patent, and Chief Medical Officer of the Company. "If current results are reproducible, the possibility that a nutraceutical would concurrently boost immunity while preserving mental health is highly enticing."

"It has not escaped us that COVID-19 is associated with increased inflammatory cytokines in the blood of patients, cytokines that also predispose to depression" said Famela Ramos, Vice President of Business Development for the Company. "It may be that the recent increase in suicides and suicide attempts is related biologically to activities of the coronavirus. It will be interesting to examine whether QuadraMune™ may modify putative negative mental effects of the virus."

"An estimated 17.3 million adults in the United States had at least one major depressive episode. This number represented 7.1% of all U.S. adults" stated Timothy Dixon, President and CEO of the Company. "We believe the Mission of our Company is not just providing a return on investment to our shareholders, but also increasing the quality of life for Americans.  We are extremely pleased to report this unexpected finding with significant potential implications to advancing non-toxic means of helping patients with this terrible condition."

1 QuadraMune(TM) for Prevention of COVID-19 - Full Text View - ClinicalTrials.gov
2 Therapeutic Solutions International Announces Positive Preclinical and Clinical Evaluation of Nutritional Supplement QuadraMune™, Designed to Protect Against COVID-19 | BioSpace
3 Ting et al. Role of Interleukin-6 in Depressive Disorder. Int J Mol Sci. 2020 Mar 22;21(6):2194.
4 O'Donovan et al. Suicidal ideation is associated with elevated inflammation in patients with major depressive disorder. Depress Anxiety. 2013 Apr;30(4):307-14.



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TSOI News: Statement of Changes in Beneficial Ownership (4) 11/30/2021 10:52:40 AM
TSOI News: Quarterly Report (10-q) 11/22/2021 09:46:59 AM
TSOI News: Notification That Quarterly Report Will Be Submitted Late (nt 10-q) 11/16/2021 01:07:34 AM
TSOI News: Statement of Changes in Beneficial Ownership (4) 10/01/2021 10:30:20 AM
TSOI News: Current Report Filing (8-k) 09/20/2021 01:29:25 PM
#44993  Sticky Note Updated TSOI full DD packet as of Monday doogdilinger 11/22/21 10:59:16 AM
#44683  Sticky Note https://www.otcmarkets.com/filing/html?id=15161255&guid=d53wkK4Kn-TCpEh 302 and 906 BigBadWolf 11/15/21 07:29:20 AM
#39793  Sticky Note You can buy a TSOI Hat now, designed Codycrusher 08/26/21 06:04:51 PM
#37207  Sticky Note 1000's of American Companies qualify for Covid grants doogdilinger 08/06/21 11:04:10 AM
#30510  Sticky Note Long post sorry - BUT ...I just jumped MaverickDillon 01/20/21 12:25:01 PM
#45386   [In other words, one optimal licensing deal with A2Z 12/01/21 11:28:33 AM
#45385   [So much for the recent HOGWASH that TSOI A2Z 12/01/21 11:26:43 AM
#45383   Exactly Lou! The only share price that remotely doogdilinger 12/01/21 11:19:07 AM
#45382   Yep! But Dr. Ichim's supposedly an unqualified buffoon doogdilinger 12/01/21 11:17:37 AM
#45381   None of the entire executive mgmt team and doogdilinger 12/01/21 11:16:09 AM
#45380   doog, my friends have to learn to be as centsability4me 12/01/21 11:09:14 AM
#45379   Insiders buying down here for a reason!! BIGMONEYPLAYA 12/01/21 11:08:57 AM
#45378   Around February, TSOI went up to .17 and TyphoonLou 12/01/21 11:08:49 AM
#45377   It's called growth Cody and understanding how dramatically doogdilinger 12/01/21 11:08:14 AM
#45376   HOGWASH, TSOI is up 10's of thousands of doogdilinger 12/01/21 11:06:41 AM
#45374   No it's due to your own buy/hold/sell decisions, doogdilinger 12/01/21 11:04:59 AM
#45373   How do you know it’s going to hit Codycrusher 12/01/21 11:04:56 AM
#45372   So complain about it, like that's gonna somehow doogdilinger 12/01/21 11:04:00 AM
#45371   lmfao @ 3 months ago the share price doogdilinger 12/01/21 11:02:41 AM
#45370   Only a dumb person sells and takes a Codycrusher 12/01/21 11:02:33 AM
#45369   3 months ago my shares were worth 50,000 Codycrusher 12/01/21 11:00:17 AM
#45368   There's always a real easy solution to any doogdilinger 12/01/21 10:59:21 AM
#45367   This has been 3 months of share price Codycrusher 12/01/21 10:58:36 AM
#45366   Last time I'll say this to you Cody! doogdilinger 12/01/21 10:58:18 AM
#45364   Who cares about the past 3 months Cody? doogdilinger 12/01/21 10:54:52 AM
#45363   So like I have stated, very disappointed I am. Codycrusher 12/01/21 10:54:42 AM
#45362   Ya, I am also concerned that Tim won’t Codycrusher 12/01/21 10:54:20 AM
#45361   Yep strawpatch! And the Kite/Gilead big board career doogdilinger 12/01/21 10:51:47 AM
#45360   Me personally, I feel disappointed in Tim in Codycrusher 12/01/21 10:50:51 AM
#45359   Canadians can no longer fly out of the doogdilinger 12/01/21 10:49:25 AM
#45358   Those who know the company know this is strawpatch 12/01/21 10:48:23 AM
#45357   haha exactly tractor! Things that make one go doogdilinger 12/01/21 10:48:02 AM
#45356   Knowing Tim supposedly won’t partner and this supposedly tractor4sale 12/01/21 10:47:15 AM
#45355   Bios require ample time to negotiate and cut doogdilinger 12/01/21 10:45:47 AM
#45354   Not any TSOI investors prob if anyone hasn't doogdilinger 12/01/21 10:41:08 AM
#45353   very true i_like_bb_stock 12/01/21 10:37:35 AM
#45352   Every dog OTC stock ran up in 1st layton 12/01/21 10:32:30 AM
#45351   Exactly bb! Are we there yet? It's beyond doogdilinger 12/01/21 10:31:44 AM
#45350   Jim Cramer wants Biden to have the US tw0122 12/01/21 10:30:12 AM
#45349   Total bs Cody! How does any biotech strike doogdilinger 12/01/21 10:29:16 AM
#45348   yep just follow him on twitter amazing i_like_bb_stock 12/01/21 10:27:28 AM
#45347   Anyone who thinks Dr. Ichim doesn't know the doogdilinger 12/01/21 10:26:42 AM
#45346   In other words, one optimal licensing deal with doogdilinger 12/01/21 10:24:44 AM
#45345   So much for the recent HOGWASH that TSOI doogdilinger 12/01/21 10:17:24 AM
#45344   No it’s a garbage stock. Truth is Tim johnnytrader33 12/01/21 10:16:23 AM
#45343   GM Shortstop doogdilinger 12/01/21 10:02:39 AM
#45342   BBW thanks for the post refreshing our memories... A2Z 12/01/21 09:32:34 AM
#45341   Knowledge is a powerful investing tool ignorance is bliss BigBadWolf 12/01/21 08:50:59 AM
#45340   Insiders buying down here! Hmmmm may grab 200k BIGMONEYPLAYA 12/01/21 01:34:18 AM
#45339   Let's Go $TSOI Arnold25764 11/30/21 10:28:20 PM
#45338   Agreed i_like_bb_stock 11/30/21 09:11:35 PM
#45337   Rock on ?? Shortstop747 11/30/21 09:05:51 PM
#45334   I never said Tim said it directly, I Codycrusher 11/30/21 08:28:20 PM
#45333  Restored Lots of chatter on the board past few morgan8 11/30/21 07:14:47 PM
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