Therapeutic Solutions International (TSOI) announced today an update on progress made by its subsidiary Campbell Neurosciences, Inc.

Campbell was founded on the principle that suicide in numerous situations is a result of biological factors that can be diagnosed and addressed using medical approaches. In contrast to other fields of medicine, to date, suicidal tendencies are only identified by subjective approaches without any biological basis. Campbell aims to reverse this.

Campbell Score: Identification and Validation of Objective Biomarker for Suicidal Ideation

The Company’s initial goal, to identify molecules associated with propensity towards suicide, was accomplished through the successful completion of phase 1/2 clinical trials demonstrating correlation between its patent-pending biomarker and suicide attempts¹.

The diagnostic test, termed the “Campbell Score” utilizes proprietary technology to accurately quantify an immunological cytokine which historically has been shown to be associated with brain inflammation. However, it has not been practically utilized as a marker of suicidality until now. Having proven the viability of this marker, the Company is currently focusing on accelerating development of a saliva-based method of assessment, which will provide in-office, real-time results. Rationale for testing of inflammatory markers as a means of quantifying suicidal tendencies was described in a paper published by the Company².

Publication and Issuance of Patents on Intervening in Suicide-Prone/Addiction/Depression

In order to provide therapeutic approaches for preventing suicide, based on reducing brain inflammation and stimulating neural regeneration, the Company has licensed and developed numerous therapeutic products. Intellectual property to both the diagnostic test and interventions has been exclusively licensed from Therapeutic Solutions International. Some of the exciting patents that have been published/issued are listed below:

1. Immunotherapy for Opioid Addiction³. This 700-claim published patent application provides means of using oxytocin and various biologics as novel treatments for opioid addiction through stimulation of neural regeneration combined with anti-inflammatory effects. Campbell is planning to partner/license with various organizations to accelerate development and/or augment existing therapeutic approaches.

2. Treatment of Major Depressive Disorder and Suicidal Ideations Through Stimulation of Hippocampal Neurogenesis Utilizing Plant-Based Approaches⁴. Various compositions of matter are disclosed which reduce depressive symptoms using non-SSRI approaches. Some of the disclosed treatment compositions include combinations of minocycline with human chorionic gonadotrophin, as well as mixtures of various inhibitors of the inflammatory pathway NF-kappa B. The compositions disclosed can be utilized as monotherapies or can be incorporated into existing conventional psychotherapy protocols. The patent application also provides means of quantifying efficacy of the intervention before clinical effects are observed.

3. Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention⁵. Protocols are disclosed for generation of unique patient-specific therapeutics to reduce some of the pathological pathways associated with propensity towards self-harm. This patent is based in part on some of the findings discovered in the Campbell Score trial.

4. Upregulation of Therapeutic T Regulatory Cells and Suppression of Suicidal Ideations in Response to Inflammation by Administration of Nutraceutical Compositions Alone or Combined with Minocycline⁶. Means of increasing levels of immune cells which possess ability to reduce brain inflammation and indirectly stimulate regeneration of damaged brain tissue are disclosed.

5. Neuroprotection and Neurodegeneration by Pterostilbene and Compositions Thereof⁷. The ability to utilize various natural compounds alone or in combination for stimulation of brain inflammation suppressing mechanisms are disclosed in this issued patent.

6. Treatment of Major Depressive Disorder by Low Dose Interleukin-2⁸. Interleukin-2 is an FDA approved immune modulating drug that has conventionally been used in treatment of cancer. Disclosed are means of using lower concentrations of this drug to induce specific immune alterations that possess therapeutic activities in major depressive disorder and other mental conditions.

7. Therapeutic Monocytes for Prevention of Suicidal Ideation⁹. Monocytes are manipulated in vitro and/or in vivo to endow specific phenotypes that induce immunological processes typically associated with remission from mental disease and/or suicidal ideations.

Expansion of Internationally Renowned Advisory Board

The Company has assembled an advisory board comprising of Dr. Peter Farrell¹⁰, Benjamin Floyd, Howard Leonhard, Dr. Pablo Guzman, J Christopher Mizer, Darren Maggot and Justin Parsons. The latest addition was Dr. Bradley Messmer (CEO of NASDAQ public company Aegirbio (AEGIR) who has successfully developed several diagnostic devices.

Closing First PPM and Increased Valuation

The Company closed its private placement memorandum at 25 cents a share in August 2022 which funded the mentioned progress. The Company has launched a new PPM at $1.00 a share in January of this year.

The protein marker that we identified has subsequently been accepted by the scientific community as playing a role in the neuroinflammatory processes associated with tendency for self-harm and other mental health issues. Based on advice from our advisory board, the Company made the decision to focus on leveraging existing data into development of a saliva-based test identifying the same protein marker. This decision was made in part because the majority of end users (psychiatrists) do not have readily available access to blood draw. Additionally, making it simpler and less traumatic is believed to increase greater compliance.

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.

¹ Therapeutic Solutions International Spin-Off Campbell Neurosciences Announces Positive Clinical Trial Results for Campbell Score Blood Based Suicide Prediction | BioSpace

² Suicide: An Immunological Disorder? by Kalina O'Connor :: SSRN

³ US Patent Application for IMMUNOTHERAPY FOR OPIOID ADDICTION Patent Application (Application #20220193127 issued June 23, 2022) - Justia Patents Search

⁴ US20220175701 TREATMENT OF MAJOR DEPRESSIVE DISORDER AND SUICIDAL IDEATIONS THROUGH STIMULATION OF HIPPOCAMPAL NEUROGENESIS UTILIZING PLANT-BASED APPROACHES (wipo.int)

⁵ US Patent Application for Personalized Immunotherapies for Reduction of Brain Inflammation and Suicide Prevention Patent Application (Application #20220088086 issued March 24, 2022) - Justia Patents Search

⁶ US Patent Application for 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 Patent Application (Application #20220062367)

⁷ 11504410 (uspto.gov)

⁸ US Patent Application for TREATMENT OF MAJOR DEPRESSIVE DISORDER BY LOW DOSE INTERLEUKIN-2 Patent Application (Application #20220362341 issued November 17, 2022) - Justia Patents Search

⁹ 20220280574 (uspto.gov)

¹⁰ Therapeutic Solutions International Announces Titan of Industry Dr. Peter Farrell Joins Advisory Board of its Suicide Prevention Spin-Off Campbell Neurosciences (prnewswire.com)

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