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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: Current Report Filing (8-k) 05/11/2022 02:02:57 AM
TSOI News: Stem Cell Company Investigating Treatment for COPD 05/09/2022 07:33:00 AM
TSOI News: Current Report Filing (8-k) 05/02/2022 12:54:12 PM
TSOI News: Statement of Ownership (sc 13g) 04/20/2022 01:28:05 PM
TSOI News: Statement of Changes in Beneficial Ownership (4) 04/11/2022 02:23:11 PM
PostSubject
#51360  Sticky Note Agreed haystax! TSOI's built the most ROCK SOLID doogdilinger 05/02/22 01:35:47 PM
#51217  Sticky Note NEWS 5/2/22 Therapeutic Solutions International Announces Launching of centsability4me 05/02/22 09:04:43 AM
#50907  Sticky Note change in sponsor update cablejohn 04/13/22 09:35:48 AM
#50360  Sticky Note Therapeutic Solutions International - TSOI centsability4me 03/27/22 01:28:41 PM
#51580   by TimGDixon » Thu May 19, 2022 7:59 am cablejohn 05/19/22 10:14:08 AM
#51579   Post by TimGDixon » Sat May 14, 2022 BigBadWolf 05/19/22 09:21:25 AM
#51578   Breast Cancer IND # 28508 COVID-19 IND # BigBadWolf 05/19/22 09:17:29 AM
#51577   As IND's are cleared we will list on cablejohn 05/19/22 09:02:11 AM
#51576   by TimGDixon » Thu May 19, 2022 7:02 am cablejohn 05/19/22 08:59:55 AM
#51575   Oh is he now ???? Hmmmmmmm, very interesting!!!!! bobthebldr 05/18/22 09:07:25 PM
#51573   AGREED They have to promote QUAD--- big cablejohn 05/18/22 09:04:13 PM
#51572   That’s cool and good to hear. Many just johnnytrader33 05/18/22 06:24:10 PM
#51571   Insider dumping, massive dilution, sub penny levels coming, tractor4sale 05/18/22 06:22:57 PM
#51570   Been knowing and interacting with BBW for several familyof5 05/18/22 04:10:06 PM
#51568   I couldn’t agree more just tells it like johnnytrader33 05/18/22 03:58:51 PM
#51567   BBW - Still my favorite poster on ihub! familyof5 05/18/22 03:58:07 PM
#51566   https://forum.therapeuticsolutionsint.com/viewtopic.php?p=2354&hilit=community+s BigBadWolf 05/18/22 01:38:42 PM
#51565   Think this sums it up for us shareholders...we morg38off 05/18/22 12:50:46 PM
#51564   it's up to CS LLC centsability4me 05/18/22 11:15:37 AM
#51563   AGREED cablejohn 05/18/22 09:15:37 AM
#51562   My thinking is, if it’s been twice as work-n-hard 05/18/22 08:01:48 AM
#51561   Agreed.. We know how long its been,, too cablejohn 05/17/22 11:03:21 PM
#51560   Okay, I'm back home now. Sorry my work-n-hard 05/17/22 10:36:52 PM
#51559   That's thing, I made no comment about what work-n-hard 05/17/22 10:33:37 PM
#51558   Should and will Have 2 different meanings-- Tim cablejohn 05/17/22 10:09:31 PM
#51557   I’m truly confused. Are you not able to work-n-hard 05/17/22 08:55:26 PM
#51556   Better Confirmed & Screenshot of https://investorshub.advfn.com/boards/read_msg.aspx?message_id= BigBadWolf 05/17/22 08:27:22 PM
#51555   So it’s frivolous and unsupported. Just confirming! NCBchBoy 05/17/22 08:17:05 PM
#51554   As I stated, my quote was from a work-n-hard 05/17/22 07:26:41 PM
#51553   Please repost the link. If not, it’s just NCBchBoy 05/17/22 07:22:55 PM
#51552   I was quoting from a link, in the work-n-hard 05/17/22 07:10:43 PM
#51551   Can you provide the link to the source NCBchBoy 05/17/22 07:05:21 PM
#51550   On Feb. 5th he said, " We should work-n-hard 05/17/22 01:53:34 PM
#51549   Excellent we'll soon see if your instincts are right! doogdilinger 05/17/22 01:40:14 PM
#51548   I meant tomorrow my bad but yes I johnnytrader33 05/17/22 01:40:04 PM
#51547   My guess is today based off other extensions johnnytrader33 05/17/22 01:39:41 PM
#51546   Agreed subs! QM is awesome! doogdilinger 05/17/22 01:39:34 PM
#51545   With the extension filed we could see the doogdilinger 05/17/22 01:38:38 PM
#51544   Agreed cents! TSOI's buildin' it & the world doogdilinger 05/17/22 01:35:46 PM
#51543   I think we will see filings tomorrow. Maybe johnnytrader33 05/17/22 12:46:14 PM
#51542   Just checked, still now Quadramune at Costco, hopefully Yooperman 05/17/22 11:53:32 AM
#51541   yes doog, centsability4me 05/17/22 11:48:58 AM
#51540   screenshots https://investorshub.advfn.com/uimage/uploads/2022/5/17/tezmzDixon_Costco1.png[/img BigBadWolf 05/17/22 11:15:36 AM
#51539   Re: Outstanding - Phase 3, EUA, Costco BigBadWolf 05/17/22 10:55:37 AM
#51538   link to any Costco deal as BS & BigBadWolf 05/17/22 10:29:08 AM
#51537   Would love to see Quadramune get bought out subslover 05/17/22 10:21:41 AM
#51536   agree subs, Costco is a great retailer, my JMC$ 05/17/22 10:19:24 AM
#51535   1st Q revs for Quadramune should be very subslover 05/17/22 10:16:43 AM
#51534   GM JMC:) doogdilinger 05/17/22 10:16:09 AM
#51533   Spot on morgan! Going to be an epic doogdilinger 05/17/22 10:15:52 AM
#51532   Morning doog and TSOI Longs Let's have a JMC$ 05/17/22 09:29:31 AM
#51531   That's right Doog...private placement funding is huge...think about morgan8 05/17/22 09:28:23 AM
#51530   BIG CEO Dixon already informed the market that doogdilinger 05/17/22 08:52:14 AM
#51529   Excellent cents! What an extraordinary journey we're embarking doogdilinger 05/17/22 08:49:20 AM
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