iBrands Corp. (IBRC)

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QuadraMune ™? in Phase II trials to test for possible Covid-19 treatment and to treat Type II Diabetes. Previously $TSOI researchers came up with the idea to test QuadraMune ™? with the world’s #1 diabetes drug, Metformin. Results found from that study prompted it to be tested in this study on humans. If this nutraceutical, QuadraMune ™? shows great improvement in cardiovascular health dealing with Covid-19 symptoms and also enhances the positive effects of the Metformin for diabetics this would be huge. IBRC & TSOI stocks would soar. Even if only one of these shows statistically significant positive results it could drive the share prices up. Here is a long analytical write-up that includes previous studies associated with QuadraMune. Keep in mind, $TSOI is the scientific company that created and is testing the drug, while IBRC is more the marketing and distributing company for the drug. Who knows which company’s share price will increase the most, better grab shares of both to make sure.

$IBRC - iBrands Corp
$TSOI - Therapeutic Solutions Intl

Current prices:
$IBRC - $.0001 (52-Wk High: $.0003 on 6/29/20)
$TSOI - $.0066 (52-Wk High: $.023 on 6/15/20)

$TSOI - scientists have a nutraceutical called QuadraMune.
$IBRC - helps market and sell the product for $39.99 on the website @ www.youcanordernow.com

https://www.youcanordernow.com/QuadraMune%E2%84%A2-60-Capsules_p_34.html

QuadraMune™ 60 Capsules
QUADRAMUNE™ 60 CAPSULES
Your Price:$68.00
Retail Price:$89.00
Part Number:QuadraMune™ 60 Capsules

Description
QuadraMune™ - A synergistic blend of pterostilbene, sulforaphane, epigallocatechingallate, and thymoquionone. For more information visit https://areyoucovidmune.com/covidmune/

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CURRENT CLINICAL STUDY:
Major clinical trial involving QuadraMune and its effects on Covid-19 and also its effects on Type II Diabetes when paired with world renowned diabetes drug, Metformin (first & #1 prescribed drug in the world for Type II diabetes).

QuadraMune(TM) for Prevention of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04421391
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
See Contacts and Locations
Sponsor:
Therapeutic Solutions International
Information provided by (Responsible Party):
Therapeutic Solutions International

Study Details Tabular ViewNo Results PostedDisclaimerHow to Read a Study Record
Study Description
Go to sections
Brief Summary:
QuadraMune(TM) is a nutritional supplement which has previously been demonstrated to possess antiinflammatory and immune modulatory activity based on in vitro and pilot in vivo studies. The current clinical trial aims to assess in a 500 volunteer trial the efficacy of QuadraMune(TM) in reducing infection in individuals at high risk of COVID-19.

Condition or disease Intervention/treatment
Phase
Covid19
Coronavirus
SARS-CoV 2
Dietary Supplement: QuadraMune(TM)

Detailed Description:
QuadraMune(TM) is composed of 4 natural ingredients.
Pterostilbene is an analogue of resveratrol, and has been shown to possess antiinflammatory activity. Additionally, this compound suppresses macrophage activation while enhancing NK activity.
Epigallocatechin gallate (EGCG) is one of the active ingredients in green tea and has been shown to act as an activator of T cells, and a suppressor of neutrophil mediated inflammation.
Sulforaphane is derived from broccoli and studies have shown that it protects lungs from inflammatory pathology.
Thymoquinone, which is chemically related to hydroxychloroquine, possessing antiviral effects and increases NK activity.
QuadraMune is a combination of these ingredients and is believed to possess superior in vitro and in vivo therapeutic properties as compared to when the ingredients are administered individually.
The study aims to assess preventative effects of QuadraMune(TM) administration for 12 weeks.
Study Design
Go to sections
Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of QuadraMune(TM) for Prevention of COVID-19 in High Risk Populations
Estimated Study Start Date :
June 8, 2020
Estimated Primary Completion Date :
November 1, 2020
Estimated Study Completion Date :
November 8, 2020
Resource links provided by the National Library of Medicine
Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome
U.S. FDA Resources

Arms and Interventions
Go to sections
Arm Intervention/treatment
Experimental: Treatment Arm
Patients will receive 2 pills of QuadraMune(TM) daily for 12 weeks
Dietary Supplement: QuadraMune(TM)
QuadraMune(TM) is a commercially available nutritional supplement

Outcome Measures
Go to sections

Primary Outcome Measures :
Prevention of COVID-19 [ Time Frame: 12 Weeks ]
Prevention of COVID-19 symptoms as recorded in a daily diary

Secondary Outcome Measures :
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events [ Time Frame: 12 Weeks ]
Assessment of adverse events and serious adverse events will be performed.

Eligibility Criteria
Go to sections

Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:
18 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Criteria
Inclusion Criteria:
Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study Male or female patients 18 years of age or older that are considered to be high-risk individuals.

High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.

Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized).

Exclusion Criteria:
Refusal to provide informed consent Any previous positive test for COVID-19 by RT-PCR Symptomatic for COVID-19 Diarrhea prior to the start of treatment Type I or II diabetes Atherosclerotic Coronary Artery Disease
Any contraindication for treatment with hydroxychloroquine including:
Hypoglycemia G6PD deficiency Porphyria Anemia Neutropenia Alcoholism Myasthenia Gravis Skeletal muscle disorder Maculopathy Changes in the visual field Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal Psoriasis Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
Contacts and Locations
Go to sections

Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421391

Contacts
Contact: Thomas E Ichim, Ph.D 18583534303 [e-mail]

Locations:
United States, California
Therapeutic Solutions International Recruiting
Oceanside, California, United States, 92056
Contact: Thomas E Ichim 858-353-4303 [e-mail]
Sponsors and Collaborators
Therapeutic Solutions International
Investigators
Principal Investigator: James Veltmeyer, MD Therapeutic Solutions International
More Information
Go to sections
Responsible Party:
Therapeutic Solutions International
ClinicalTrials.gov Identifier:
NCT04421391 History of Changes
Other Study ID Numbers:
QuadraMune002
First Posted:
June 9, 2020 Key Record Dates
Last Update Posted:
June 9, 2020
Last Verified:
June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided

Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Therapeutic Solutions International:
Immunology
Innate Immune System
Additional relevant MeSH terms:
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases

Major Clinical study set to conclude between 11/01/20-11/07/20

- 3rd party has to validate research results which should take 2-4 weeks. Final results should be known at the latest by 12/07/20.

- I expect the results to be positive/effective enough against both Covid-19 & Type II Diabetes that the share price for $IBRC reaches $.02 and $TSOI reaches $.25.

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OTHER STUDIES involving QuadraMune:

(1) DATE: 08/28/20

Therapeutic Solutions International Reports Synergistic Suppression of Suicide-Associated Neuroinflammatory Pathway by QuadraMune™ and Minocycline
August 28, 2020, 6:30 am
Campbell Neurosciences Division Continues its Mission of "Treating Suicide as a Biological Disease"

OCEANSIDE, Calif., Aug. 28, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported filing a patent on new data showing synergy between QuadraMune™ and Minocycline in generating a type of immune cell termed T regulatory cell.

T regulatory cells suppress pathological inflammation, including interleukin-6, which is associated with suicidal ideation, as well as risk of COVID-19 associated death.

QuadraMune™ is a nutraceutical developed by the Company which is currently in a clinical trial for prevention of COVID-19[1]. Minocycline is an antibiotic that is approved by the FDA.

"The recent data supports initiation of clinical trials combining QuadraMune and Minocycline for reduction of suicidal ideations and hopefully preventing suicides" said Kalina O'Connor, Director of the Campbell Neurosciences Division of Therapeutic Solutions International and co-inventor of the patent. "I am thankful to Mr. Dixon and the team at TSOI for having the courage to attack suicide as a biological disease."

Campbell Neurosciences was formed as a Division of the Company to address suicide from an immunological perspective. The company is named after Kathleen Campbell, the mother of Kalina O'Connor, who was a victim of suicide.

"The potent generation of T regulatory cells by the combination of QuadraMune™ and Minocycline suggests that the therapeutic effects of the combination may be long lasting due to the fact that T regulatory cells have a long life in the body and can replicate" said Famela Ramos, Director of Business Development. "The ability of the T regulatory cells generated to suppress interleukin-6 and macrophage activation supports the possible use of this combination for other neurogenerative diseases associated with inflammation."

"By combining quantitative measurements such as the Campbell Score™, with practical interventions such as QuadraMune™ with adjuvants such as Minocycline, we believe that we are primed for initiating a new way of treating suicide based on objective immunology and not speculation" said Timothy Dixon, President and CEO of the Company and co-inventor of the patent. "We thank our Scientific Advisory Board for their leadership in stimulating us to explore this fascinating and underdeveloped area of medicine."

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] https://clinicaltrials.gov/ct2/show/NCT04421391

Therapeutic Solutions International, Inc.
[e-mail]

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(2) DATE: 08/05/2020
https://www.wfmz.com/news/pr_newswire/pr_newswire_health/therapeutic-solutions-international-reports-reduction-of-inflammation-associated-memory-impairment-by-quadramune-tm-administration/article_70dae53b-5c65-57f3-adce-ac06e0a83968.html

Therapeutic Solutions International Reports Reduction of Inflammation Associated Memory Impairment by QuadraMune(TM) Administration
Animal Data has Potential Implications for Ongoing COVID-19 Prevention Study Company Continues Quest to Dominate Intellectual Property Regarding COVID-19 Associated Pathologies

By Therapeutic Solutions International Aug 5, 2020 Updated Aug 5, 2020
OCEANSIDE, Calif., Aug. 5, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), announced today filing of a patent on new data demonstrating memory-protective effects of QuadraMune™ in an animal model of inflammation associated memory loss.

Animals were treated with QuadraMune™ for 3 days and exposed to lipopolysaccharide, which serves as an inflammatory stimulus. Subsequently, the ability of animals to remember a submerged platform was assessed. In agreement with previously published studies, lipopolysaccharide administration resulted in approximately 57% reduction in memory. Animals which received QuadraMune had restoration of memory activity. Additionally, it was demonstrated that QuadraMune™ reduced the presence of proteins associated with inflammation in the brain, termed cytokines.

"The current data is an extension of our ongoing obsession with identifying mechanisms by which QuadraMune™ works and expanding its potential for other diseases. It is known that conditions such as Alzheimer's Disease, Multiple Sclerosis and Parkinson's Disease are all associated with brain inflammation [1, 2]," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The same cytokines, such as interleukin 6, that we are reducing with QuadraMune™ in the brain, are associated with COVID-19 severity [3]. Studies show that viral infections in general, and especially the SARS-CoV-2 virus, can cause memory impairment. It will be interesting to explore whether QuadraMune™ may have therapeutic effects in this arena."

QuadraMune™ is comprised of green tea extract, pterostilbene, nigella sativa, and sulforaphane. Studies published in the peer-reviewed literature have shown that these ingredients by themselves possess anti-inflammatory [4-7], neuroprotective [8-13], and immune stimulatory properties [14-17].

"It has not escaped us that mental health issues such as dementia and depression are associated with inflammatory cytokines [18, 19]. We are currently investigating the possibility of utilizing QuadraMune™ or similar formulations for psychiatric indications," said Famela Ramos, director of business development and co-inventor on the patent.

"I am very thankful for our scientific advisory board, and our research collaborators who are working tirelessly to advance QuadraMune™ into new indications, as well as identifying mechanisms of action," said Timothy Dixon, President and CEO of the Company. "We plan to continue expanding our collaborations and strengthening our science and portfolio, because at the end of the day, the best marketing is when the science speaks for itself."

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 , our public forum where all are welcome is https://board.therapeuticsolutionsint.com/ and all referenced lit may be reviewed here: https://therapeuticsolutionsint.com/news-8-5-2020-refrences/

Therapeutic Solutions International, Inc.
[e-mail]

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Therapeutic Solutions International Files Patent on Ability of QuadraMune Ingredient Pterostilbene to Reduce Inflammation while Stimulating Brain Protective Biological Pathways
Published: July 28, 2020 at 9:45 a.m. ET

OCEANSIDE, Calif., July 28, 2020 /PRNewswire via COMTEX/ -- OCEANSIDE, Calif., July 28, 2020 /PRNewswire/ -- Therapeutics Solution International, Inc., (OTC Markets: TSOI), reported new data demonstrating that the blueberry derived compound pterostilbene possesses numerous brain protective and potentially brain regenerative activities. Pterostilbene is one of four ingredients which comprise QuadraMune™, a nutraceutical being developed by the Company which is currently in a clinical trial for prevention of COVID-19. Information on the clinical trial can be found on the Government Clinical Trials website https://clinicaltrials.gov/ct2/show/NCT04421391.

"These new data confirm previous findings published on pterostilbene and also reveal novel therapeutic properties of this naturally occurring nutrient," said Dr. James Veltmeyer, Chief Medical Officer of the Company and Voted Top Doctor of San Diego. "By continually investigating mechanisms of action of our products, our ambition is to ensure we have support of the top medical and scientific leaders. In my opinion, many times, it does not matter how good your product is, what matters is that you have scientific basis for why it works. This is especially important in the current age of molecular medicine."

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The data disclosed by the Company indicates:

a) pterostilbene suppresses inflammatory cytokines TNF-alpha, IL-1 beta and IL-6;

b) pterostilbene inhibits death of neurons caused by inflammatory mediators;

c) pterostilbene stimulates production of regenerative factors from cells in the brain such as BDNF, NGF, FGF-1, and FGF-2; and

d) pterostilbene allows/enhances proliferation of endogenous brain stem cells.

"The importance of possessing a deep scientific understanding of your product can be seen in the example of nutraceuticals which ended up obtaining regulatory clearance as drugs," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "For example, Lovaza and Vascepa are both fish oil based products which have been developed scientifically and FDA approved through clinical trials. Lovaza, which is sold by GSK, had sales of approximately 1 billion per year and is used for reduction of triglycerides.1 Vascepa, sold by Amarin, had sales in 2019 of 410 million and is used to prevent heart attacks.2 We believe that similar developmental pathways may be possible with several of our existing products."

The Company is currently pursuing FDA clearance for its cell therapy produce StemVacs, for which an IND number was previously granted. The Company's in-licensed stem cell, the JadiCell has FDA clearance for other indications.

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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, our public forum is https://board.therapeuticsolutionsint.com/.

1 http://www.pmlive.com/pharma_news/teva_launches_first_generic_of_gsks_lovaza_in_us_559273

2https://www.fool.com/investing/2020/01/07/amarin-reports-preliminary-vascepa-sales-projects.aspx

Therapeutic Solutions International, Inc.
[e-mail]

View original content:http://www.prnewswire.com/news-releases/therapeutic-solutions-international-files-patent-on-ability-of-quadramune-ingredient-pterostilbene-to-reduce-inflammation-while-stimulating-brain-protective-biological-pathways-301101258.html

SOURCE Therapeutic Solutions International



(#) DATE: 06/04/2020
https://www.prnewswire.com/news-releases/therapeutic-solutions-international-announces-positive-preclinical-and-clinical-evaluation-of-nutritional-supplement-quadramune-designed-to-protect-against-covid-19-301070796.html

Therapeutic Solutions International Announces Positive Preclinical and Clinical Evaluation of Nutritional Supplement QuadraMune™, Designed to Protect Against COVID-19
Company Submits Results of Clinical Trial for Publication in Peer-Reviewed Medical Journal

NEWS PROVIDED BY
Therapeutics Solutions International, Inc.
Jun 04, 2020, 09:08 ET
OCEANSIDE, California, June 4, 2020 /PRNewswire/ -- Therapeutics Solutions International, Inc., (OTC Markets: TSOI) announced today the submission to an international medical journal the results of pre-clinical and clinical evaluation of QuadraMune™ in 32 healthy volunteers between 18-65 years of age, lacking chronic or active disease.

The study comprised of 4 groups of patients who received QuadraMune™, or placebo. Group 1 was placebo control, Group 2 received 2 capsules per day, group 3 received 4 capsules per day, and group 4 received 8 capsules per day. The trial lasted 7 days. QuadraMune™ was provided by Therapeutic Solutions International.

"To date, there are no FDA cleared means of preventing COVID-19. Despite work being performed at 'Warp-Speed' towards vaccine development, these efforts are still believed to be months if not years away," said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International and "Top Doctor" of San Diego in 2012, 2014, 2016, 2017, and 2019. "We aimed to perform a series of experiments to assess preclinical and pilot clinical feasibility of QuadraMune™ to address the issue of immune stimulation while inhibiting inflammation. The current data strongly supports that the combination of natural ingredients in QuadraMune™ possesses a synergistic effect at suppressing key components of 'Cytokine Storm,' namely interleukin-6 and TNF-alpha. If studies continue to support these conclusions, future use of QuadraMune™ in conditions such as cancer inflammation and rheumatoid arthritis will be considered."

The cytokine interleukin-6 is considered a cornerstone of the inflammatory response. Suppression of interleukin-6 for pathological inflammation, such as in rheumatoid arthritis, is the basis of the drug Actemra (Tocilizumab). Manufactured by Roche, this drug had sales of $2.4 billion dollars last year.[1]

"In vivo administration of QuadraMune™ was successful in stimulating markers of immunity both at the level of the innate immune response, and adaptive immune responses," said Timothy Dixon, President, and CEO of Therapeutic Solutions International. "Many approaches that suppress inflammation also suppress immunity. In order to have a fighting chance, any approach being developed for this condition must induce both the suppression of inflammation and the activation of immunity. These early data support this statement."

The Company plans to expand clinical trials to patients suffering from COVID-19 and/or individuals at risk of COVID-19. A pre-publication copy, of the submitted manuscript, is available by following this link: https://therapeuticsolutionsint.com/CV/JTRM-D-20-01014.pdf.

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. Immune modulation refers to the ability to upregulate (make more active) or downregulate (make less active) one's immune system. The Company's corporate website is at www.therapeuticsolutionsint.com and our e-commerce is at www.youcanordernow.com and for additional info on QuadraMune™ visit www.areyoucovidmune.com/covidmune/.

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

1. https://www.fiercepharma.com/pharma-asia/china-turns-roche-arthritis-drug-actemra-against-covid-19-new-treatment-guidelines

Nutraceutical Product Appears to Stimulate Natural Killer Cell Arm of Immune System
Contact:
Timothy Dixon
Therapeutic Solutions International, Inc.
[e-mail]
[phone]

SOURCE Therapeutics Solutions International, Inc.

Related Links

https://therapeuticsolutionsint.com

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