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Therapeutic Solutions International with Subsidiary Campbell Neurosciences Develops Cord Blood Based Inhalable Product for Opioid Addiction

Company Announces Second Therapeutic Candidate for Leveraging Regenerative and Immunological Approaches for Overcoming > $78.5 Billion Dollar Addiction Epidemic


https://www.prnewswire.com/news-release ... 67713.html


ELK CITY, Idaho, April 13, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced filing of a patent with new data covering a cord blood based intranasal product demonstrated to reduce adverse mental effects associated with opioid addiction.

In the series of studies, inflammation was stimulated in the brains of animals using inducers and activators of TLR4, a protein associated with opioid addiction. Administration of the Company's cord blood based therapeutic resulted in suppression of TLR4 as well as inhibition of inflammation in the brain.

"In recent times numerous publications have reported the link between brain inflammation and opioid addiction1,2" said Dr. James Veltmeyer, Chief Medical Officer of Campbell Neurosciences. "By combining the regenerative effects of umbilical cord blood, with the anti-inflammatory properties of NanoStilbeneä, together with proprietary neuromodulating agents, we have created a treatment approach which appears to be safe and potently effective in our preclinical studies."

"Campbell Neurosciences is focused not just on identifying suicidal ideations utilizing our clinically validated Campbell Score™ blood-based test, but also on providing possible solutions to prevent suicide," said Kalina O'Connor, President and CEO of Campbell Neurosciences. "The announcement of preclinical success using our cord blood based approach sets the foundation for optimization and development of a clinically-useful approach to treat this dreaded disease."

"Current approaches to drug addiction many times involve replacing one addiction with another one, while not addressing the root cause," said Timothy Dixon, President and CEO of Therapeutic Solutions International, the Parent Company of Campbell Neurosciences and co-inventor of the patent. "We are glad to lend our immunological expertise to Campbell Neurosciences for the development of the world's first immunotherapeutic approach to opioid addiction."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

ir@tsoimail.com

1 Eidson et al. Inflammatory mediators of opioid tolerance: Implications for dependency and addiction. Peptides. 2019 May;115:51-58.
2 Hofford et al. Neuroimmune mechanisms of psychostimulant and opioid use disorders. Eur J Neurosci. 2019 Aug;50(3):2562-2573.

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Therapeutic Solutions International Spin-Off Campbell Neurosciences Identifies Mechanism of Action for Umbilical Cord Blood Derived NarcoStem™ Drug Rehabilitation Product

Company Demonstrates Key Role for "Endogenous Nerve Repair Compound" in Mediating Therapeutic Activities of Novel Regenerative Approach


https://www.prnewswire.com/news-release ... 71379.html


ELK CITY, Idaho, April 19, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today data implicating a key role in the protein Brain Derived Neurotrophic Factor (BDNF) in the therapeutic activities of NarcoStem™, an umbilical cord blood derived biologic demonstrated to possess positive animal data in preclinical models of addiction and drug induced brain damaged.

"It is saddening that what many consider to be cutting edge approaches to treatment of drug addiction is simply replacement of one harmful drug with another drug," stated Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International and Top Doctor of San Diego. "I am proud to work with TSOI and with Campbell Neurosciences at creating a therapy that concurrently reduces brain inflammation, suppresses addiction associated urges, while at the same time repairs damaged nerve tissue. This is not something that ketamine, CBD, or psilocybin are capable of doing. Demonstration that BDNF mediates therapeutic activities of NarcoStem™ helps accelerate the timeline for clinical translation of this inhalable therapeutic."

BDNF is considered a "master molecule" in controlling brain function and has been reported by numerous groups to associate with efficacy of anti-depressants, as well as the ability to overcome addictive tendencies. Unfortunately, it is almost impossible to provide recombinant BDNF directly into the brain due to its size and half live. Accordingly, preliminary data by the Company suggests that administration of NarcoStem™ can directly stimulate the brain to produce its own BDNF.

"The recent successes in obtaining positive clinical data for both the Campbell Score and the Kaihani Score pushes us to initiate creation of therapeutic approaches to actually intervene at suicidal ideations and conditions predisposing to these conditions," said Kalina O'Connor, President and CEO of Campbell Neurosciences. "It is fundamentally important that we know the mechanisms of action for our products and we are extremely satisfied at the "Warp Speed" that our scientists have been working on to generate this exciting data."

"The staggering rise in drug addiction, as well as the disturbing news that as many as 1 out of 3 post-covid patients will suffer neurological manifestations, is very strong rationale for our 'hyper-acceleration,' in developing regenerative approaches to neurological issues," said Timothy Dixon, President and CEO of TSOI. "We look forward to continuing our collaborations with internationally renowned scientists dedicated to utilizing modern day approaches to solve this age-old curse of drug addiction."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

ir@tsoimail.com

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Therapeutic Solutions International

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Therapeutic Solutions International Reports Regression of Established Tumors by Combining its Cancer Blood Vessel Targeting Immunotherapy with Low Dose Chemotherapy

Unexpected Efficacy in Reduction of Melanoma, Glioma, and Lung Cancer Models Supports Company's Rational for Advancing its Stem Cell Derived Platform to Multi-Cancer Clinical Trials


https://www.prnewswire.com/news-release ... 76645.html


ELK CITY, Idaho, April 26, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today new data demonstrating an unexpected synergy between its inducible pluripotent stem cell (StemVacs-V iPSC) derived immunotherapy product with low dose cyclophosphamide in evoking potent immune mediated cancer regression.

In a series of experiments, the Company demonstrated that its previously announced stem cell derived tumor endothelial-like cell vaccine1 enabled non-toxic doses of cyclophosphamide, an established chemotherapeutic agent, to induce significant reduction of established lung cancers, brain cancers, and skin cancers in animal models. Furthermore, it was demonstrated that reduction of tumors was associated with increased infiltration of immune cells.

"Previous companies, such as Batu Biologics, have demonstrated the clinical safety of using the immune system to selectively kill the blood vessels that feed cancer2, which was validated by FDA clearance3 to initiate clinical trials," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "As a physician who sees firsthand the suffering of cancer patients caused by current chemotherapy protocols, the thought of leveraging the patient's own immune system to allow for increased efficacy with reduced toxicity is extremely exciting."

"From a business perspective, one of the significant hurdles preventing advancement in cancer therapeutics is lack of interdisciplinary collaboration," said Famela Ramos, Vice President of Business Development. "The demonstration that our immunotherapy possesses ability to potentiate anticancer activities of existing therapeutics, thus allowing for utilization of lower doses while retaining efficacy, is a game changer in my opinion."

"The idea that killing tumor blood vessels weakens cancer, and thus allows for lower doses of chemotherapy to be effective is very attractive. This concept has been validated in clinical trials which involved combinations of chemotherapy with the antiangiogenic activities of the monoclonal antibody drug Avastin," said Timothy Dixon, President and CEO of the Company. "Based on side-to-side comparisons, our stem cell based immunotherapy appears substantially more efficacious in inducing immune mediated "choking" of the tumor blood supply and demands deeper investigation."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Therapeutic Solutions International Demonstrates Potent and Selective Destruction of Tumor Blood Vessels by Leveraging Pre-Existing Natural Anti-Xenogeneic Antibodies (prnewswire.com)2 Safety of targeting tumor endothelial cell antigens | Journal of Translational Medicine | Full Text (biomedcentral.com)
3 Batu Biologics Receives FDA Clearance for First Multi-Pronged Immunotherapy Targeting the Blood Vessels That Feed Cancer | BioSpace

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Therapeutic Solutions International Comes to Agreement with FDA on Clinical Trial Design for First Stem Cell Clinical Trial in Chronic Traumatic Encephalopathy (CTE) Patients

Company to Address Minor Comments from FDA Before Initiating Clinical Trial


https://www.prnewswire.com/news-release ... 81061.html

ELK CITY, Idaho, April 30, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today receipt of a written communication from the Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application, which was granted number 27377.

"We are pleased that the FDA has thoroughly reviewed our proposed clinical trial and agrees with us that chronic traumatic encephalopathy (CTE) is a valid disease indication for potential therapeutic intervention," stated Dr. James Veltmeyer, Chief Medical Officer of the Company and Top Doctor of San Diego. "Classically, the perception is that CTE can only be diagnosed post-mortem. The fact that the FDA is open to allowing our protocol, with minor changes, strongly supports development of regenerative-based approaches for this terrible condition."

The FDA requested several changes to the IND and clarifications centered around manufacturing, delivery, and monitoring of the cellular product before patient treatment can be initiated.

In regard to recognition of CTE as a valid clinical indication, the FDA stated, "To limit the number of subjects being exposed to unknown but potentially significant risk(s), please modify your protocol to include an appropriate staggering period between consecutive subjects for the first several subjects." Additionally, the FDA requested that the Company potentially exclude pediatric patients and patients unable to provide proper informed consent.

"To our knowledge, we are the only entity actively developing regenerative based therapeutics for CTE through legitimate regulatory pathways," said Famela Ramos, Vice President of Business Development. "Society enjoys the entertainment of modern-day gladiators (football players) and the freedom and security afforded to us by our military. Unfortunately, these brave individuals are forgotten once they develop mental issues which are caused as a result of their occupation."

"As a Company, we are pleased that the FDA is open to our parameters for classifying CTE while patients are pre-mortem," said Timothy Dixon, President and CEO of the Company. "Based on the experiences of our clinical team and advisors, we are confident in responding to the FDA's questions in a timely manner."

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

ir@tsoimail.com

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Therapeutic Solutions International

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