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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: Therapeutic Solutions talks up suicide prevention study preclinical data 03/04/2021 09:18:03 AM
TSOI News: Current Report Filing (8-k) 02/26/2021 11:51:02 AM
TSOI News: Current Report Filing (8-k) 12/30/2020 05:33:47 PM
TSOI News: Statement of Changes in Beneficial Ownership (4) 12/30/2020 04:13:23 PM
TSOI News: Statement of Changes in Beneficial Ownership (4) 12/30/2020 04:10:25 PM
PostSubject
#30510  Sticky Note Long post sorry - BUT ...I just jumped MaverickDillon 01/20/21 12:25:01 PM
#32091   great news @ the end of the day centsability4me 03/05/21 06:27:21 PM
#32090   That's how it's done. I originally bought my fsshon 03/05/21 04:21:07 PM
#32089   Anything at this level is a gift . FROZENFLAME 03/05/21 03:07:58 PM
#32088   It will and very fast . FROZENFLAME 03/05/21 03:05:40 PM
#32087   Buy this Baby back .10. Let's go. Going fsshon 03/05/21 03:04:43 PM
#32086   Little bit more for me :-) FROZENFLAME 03/05/21 02:59:29 PM
#32085   Good to see TSOI in the green - no_ur_stox 03/05/21 01:52:22 PM
#32084   With 120k shares bought at avg .011 I'm dv22192 03/05/21 01:10:37 PM
#32083   The run up will be too fast, very FROZENFLAME 03/05/21 12:57:10 PM
#32082   Agree, should see some big buying by the FROZENFLAME 03/05/21 12:55:23 PM
#32080   I put 20k on.05 and Boom it went fsshon 03/05/21 12:34:57 PM
#32079   We have a few options We can say ‘well, rrao11 03/05/21 12:29:16 PM
#32078   Excellent, more Longs need to support the Bid x-ray-eyes 03/05/21 12:21:19 PM
#32077   Adding 100K shares for me :-) FROZENFLAME 03/05/21 11:37:36 AM
#32076   I agree, there has to be oversight, above x-ray-eyes 03/05/21 11:03:07 AM
#32075   complaining to the agencies centsability4me 03/05/21 10:51:01 AM
#32074   Yep, 2021's forever gonna be known in OTC doogdilinger 03/05/21 10:46:32 AM
#32073   TSOI Tim, we stand with you in the x-ray-eyes 03/05/21 10:45:17 AM
#32067   You bet doogi! Into the stronger hands rrao11 03/05/21 09:34:14 AM
#32064   can you post a link to the forum TAB78 03/05/21 09:25:57 AM
#32063   GM everyone, thanks to the panic sellers I doogdilinger 03/05/21 09:23:26 AM
#32062   Stock should have been at or near a fsshon 03/04/21 05:49:24 PM
#32061   We don't run with lamb chops in TSOI. centsability4me 03/04/21 03:30:58 PM
#32060   Yep, I can rattle off over 4 dozen doogdilinger 03/04/21 01:44:19 PM
#32059   You bet! It will work out just rrao11 03/04/21 01:42:40 PM
#32058   Exactly subs buddy! 2021, the year of the doogdilinger 03/04/21 01:42:23 PM
#32057   I will bet anyone that time proves my doogdilinger 03/04/21 01:41:14 PM
#32056   That my doogi is being worked on as subslover 03/04/21 01:40:26 PM
#32055   Agree doogi! Longs will be fine! rrao11 03/04/21 01:03:16 PM
#32054   The best part about all that is this doogdilinger 03/04/21 12:44:40 PM
#32053   Another msg from Tim on the Forum. rrao11 03/04/21 12:42:48 PM
#32052   Thanks for the additional gift cheapies panic sellers! doogdilinger 03/04/21 11:45:46 AM
#32051   Excellent rrao11, know what you're loadin' b4 they doogdilinger 03/04/21 11:45:09 AM
#32050   That is an awesome list Cents! rrao11 03/04/21 11:11:13 AM
#32049   Wow Cents!!!, Excellent!!!, I think there is a Rollo P. Coltrane 03/04/21 10:36:08 AM
#32048   Msg from $TSOI CEO Tim Dixon! $TSOI rrao11 03/04/21 10:35:36 AM
#32047   I'm not going anywhere, TSOI is a spectacular strawpatch 03/04/21 10:28:26 AM
#32046   building a patent portfolio centsability4me 03/04/21 09:59:40 AM
#32045   Awesome news, TSOI is really something to own. Yooperman 03/04/21 09:46:24 AM
#32044   GM Neb brotha, more real deal news released doogdilinger 03/04/21 09:42:44 AM
#32043   Fantastic News! Love it! This is rrao11 03/04/21 09:40:05 AM
#32042   TSOI Incredible cutting-edge company, love this team x-ray-eyes 03/04/21 09:14:44 AM
#32041   good morning $TSOI Nebuchadnezzar 03/04/21 09:14:36 AM
#32040   Nice news! gotinearly 03/04/21 09:10:33 AM
#32039   NEWS 3/4/21 Therapeutic Solutions International Spin-off Campbell Neurosciences centsability4me 03/04/21 09:04:20 AM
#32038   I'm comparing data, and trying to find the centsability4me 03/04/21 07:01:55 AM
#32037   no_ur_stox you know it all as you mentioned ADVFN_curncman 03/03/21 08:40:37 PM
#32036   Huge potential, long term investment, it’s one of FROZENFLAME 03/03/21 08:16:26 PM
#32035   Thank you for sharing your insights Stockgamer2020 03/03/21 07:43:35 PM
#32034   FrozenFlame - you are right. Dimes to dollars. xstream 03/03/21 06:37:34 PM
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