https://forum.therapeuticsolutionsint.com/viewtopic.php?t=791

https://forum.therapeuticsolutionsint.com/viewtopic.php?f=2&p=20820#p20820

by TimGDixon » Tue Jun 13, 2023 7:29 am
Yeah we have received an award from the Right To Try Foundation but you know whats more rewarding was seeing one of our ards patients, 85 years old, who survived and made it home for Christmas to celebrate with his 85yr old wife of 65 years. He could represent any of you. No one is immune to these things. No kidding we moved this patient from hospital to specialized care facility at 2am and by 6am Dr. V was there transfusing cells and a few weeks later he was celebrating Christmas.

yES CLICK AND PASTE SO beat me with a wet noodle and make me cry--- oh I forget what

by TimGDixon » Sat Jun 10, 2023 6:56 am

I have been holding since 2010 and hold shares at 18 cents

4 grand+ to read the report GO TSOI--12.42 a page

by TimGDixon » Wed May 17, 2023 6:55 pm

Codycrusher wrote: ?Wed May 17, 2023 6:51 pm
Oh ok I understand, what about a commercialization, the subsidiary would be bringing in billions if not 10-20-30 billion a year or more from a breast cancer treatment if you get that commercialized for example, if TSOI owns for example 20% ownership, would that hurt the fact of those profits reflecting on TSOI big time?
Not sure I follow you. But I think you are saying if reno went all the way to fda approval we would own 20%>? We own 65% now - how do you get us to 20%? The other phase(s) I assume you mean and so yes in that case we could own considerably less than we do now but thats not necessarily the plan for reno. The plan for reno is to complete phase 1/2 breast cancer and sell the company. In that case when sold we own about 57%.

Remember TSOI owns all the patents and the licensing agreements either stay in place with new owner in the case of a buyout or the new owner buys out the license from TSOI - either way TSOI is in for much more than the stock.

by cablejohn45 » Sat May 20, 2023 11:21 am

Peep came up with (inadvertently) a good question:
Upon receipt of an IND application, FDA will notify the sponsor of the date it receives the application through an IND acknowledgment letter.
Has TSOI received this letter?

ans;

by TimGDixon » Sat May 20, 2023 11:38 am

No we hadn't as of yesterday's mail which is why this whole stupid thing about 30 days is ridiculous. I'm not required to tell you folks every little detail of every little thing. I have said consistently that when I have some Intel we will make it public. These people are using some arbitrary Date of a news release to stir all this up. I'll say it again and then no more. When we have news we will inform you.

by TimGDixon » Fri May 19, 2023 7:26 am

Hans De Vries wrote: ?Fri May 19, 2023 6:37 am
This thread is the type of interesting and critical discussions I really enjoy reading on the forum. :geek:

Keep up the good work ;)
TimGDixon
Codycrusher
noslippas808
trader32176

I look forward to the time when the tide finally turns favorable for all of us again :roll: :?:
I just listed our 35th drug in our pipeline (VSX-001) all of them having preclinicals completed, 5 of them in human development.
How much does preclinical trials cost?
R&D Costs | Knowledge Portal
Total supporting preclinical studies were estimated to require 73 months and cost USD 7 million for drugs and 47 months and USD 6.3 million for biologics.
VasoSome’s product VSX-001 is a proprietary nanoparticle derived from specialized stem cells that can be utilized in a “universal donor” manner, meaning it does not have to be matched with the donor. The product possesses numerous properties of stem cells, including inhibition of inflammation, suppression of damage to blood vessels, and ability to regenerate damaged tissue. Advantages of administering VSX-001 compared to stem cells include: a) VSX-001 is substantially smaller in size than stem cells, allowing for superior distribution; b) VSX-001 does not multiply, thus possessing a superior long-term safety profile; and c) VSX-001 can be manufactured more economically as compared to stem cells.

Aneurysm Treatment by Exosomes which provides means of inhibition and/or treating aneurysms and other degenerated blood vessels through administration of regenerative cell derived exosomes, and/or regenerative cell derived apoptotic bodies. In one particular embodiment vessel regeneration is increased through administration of stem cell exosomes/or stem cell apoptotic bodies. Other embodiments include regeneration of vessels prone to aneurysms, repairing aneurysms of vessels, or acceleration of endothelialization after stent placement. Provided within the invention are methods of rejuvenating properties of said vessels associated with physiological health, examples of which include appropriate production of anti-coagulating/clotting factors, control of angiogenesis, and appropriate revascularization of injured tissue.

Remember TSOI owns all the patents and the licensing agreements either stay in place with new owner in the case of a buyout or the new owner buys out the license from TSOI - either way TSOI is in for much more than the stock.

Interesting;

by TimGDixon » Wed May 17, 2023 6:55 pm

Codycrusher wrote: ?Wed May 17, 2023 6:51 pm
Oh ok I understand, what about a commercialization, the subsidiary would be bringing in billions if not 10-20-30 billion a year or more from a breast cancer treatment if you get that commercialized for example, if TSOI owns for example 20% ownership, would that hurt the fact of those profits reflecting on TSOI big time?

Not sure I follow you. But I think you are saying if reno went all the way to fda approval we would own 20%>? We own 65% now - how do you get us to 20%? The other phase(s) I assume you mean and so yes in that case we could own considerably less than we do now but thats not necessarily the plan for reno. The plan for reno is to complete phase 1/2 breast cancer and sell the company. In that case when sold we own about 57%.

now back to barking and back biting

heres an exercise Cody. You have licensed from TSOI the same patents Res Nova has:

On November 08, 2022, the Company licensed from Therapeutic Solutions International, Inc., the following patent:

·Application No.: 63/161526 titled as: Pluripotent Stem Cell Derived Dendritic Cells and Engineered Dendritic Cells for Cancer Immunotherapy.

Abstract:
Disclosed are populations of dendritic cells generated from stem cells capable of inducing immunity towards cancer. In one embodiment said dendritic cells are generated from allogeneic inducible pluripotent stem cells, for some uses, said pluripotent stem cells are genetically engineered/edited to induce cancer specific immunity and/or resist immunosuppressive effect of tumor derived microenvironment. In one embodiment pluripotent stem cells are transfected with cancer stem cell antigens such as BORIS and/or NR2F6.

On February 15, 2023, the Company licensed from Therapeutic Solutions International, Inc., the following patent:

Application No.: 63/445872 titled as: Enhancement of Anti-Angiogenic Cancer Immunotherapy by Abortogenic Agents .

Abstract:
The current invention provides means of suppressing tumor associated immune inhibition through administration of progesterone and/or glucocorticoid receptor antagonists such as RU-486. In one embodiment the invention provides the concurrent utilization RI-486 and anti-angiogenic immunotherapy. In another embodiment, abortogenic inhibitors of immunity such as indolamine 2,3 dioxygenase are administered together with RU-486 and/or anti-angiogenic immunotherapy. Various antiangiogenic agents can be utilized in the practice of the invention including the ValloVax immunotherapy and/or the StemVacs-V therapy.

You also bought from us the IND for Breast Cancer using the first listed patent. When you started your company you owned 100% of the stock but you need to raise $4,000,000 for clinical trial.

What will your stock structure look like to support all this, fund the trial for phase 1 and keep control. You need to hire chief science officer, chief medical officer, chief financial officer and they take equity in lieu of cash salary.

Tell me what you would do to get all this going and still have lots of ownership?

by TimGDixon » Wed May 17, 2023 5:10 pm

Thought would provide an update or overview of current ownership in our subs.
https://forum.therapeuticsolutionsint.com/viewtopic.php?t=756

Gasp a real company https://curestatrx.com/

https://www.businesswire.com/news/home/20230515005454/en/Therapeutic-Solutions-International-Spin-Off-Res-Nova-Bio-Partners-with-Cure-Stat-Rx-to-Manufacture-First-in-Class-Breast-Cancer-Immunotherapy-Product-FloraStilbene%E2%84%A2

TSOI Excelsior!

message so good it went in twice YAWN-- meanwhile by TimGDixon » Fri May 12, 2023 5:27 pm
Its bigger than all that Cody because if we are successful pulling data from phase 3 and requesting upgrade of COPD to phase 3 then that paves the way for asthma, bronchitis, emphysema, pulmonary fibrosis, etc. They could all be initially filed as phase 3's based on the drug master file if it all works and we have high confidence.

YAWN-- meanwhile by TimGDixon » Fri May 12, 2023 5:27 pm
Its bigger than all that Cody because if we are successful pulling data from phase 3 and requesting upgrade of COPD to phase 3 then that paves the way for asthma, bronchitis, emphysema, pulmonary fibrosis, etc. They could all be initially filed as phase 3's based on the drug master file if it all works and we have high confidence.

by TimGDixon » Mon May 08, 2023 10:16 am

Codycrusher wrote: ?Mon May 08, 2023 9:18 am
If you had a successful phase 1 than wouldn’t you aim for phase 2 after and than phase 3 and commercialization for this sort of treatment method if the trial is successful?


I don't think you quite understand

What is 505(b)(2)?
Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosmetic Act, the 505(b)(2) pathway expressly permits the US Food and Drug Administration (FDA) to rely, for approval of NDAs, on data not developed by the applicant.

What are the benefits?
• Eliminate costly and time-consuming duplicative clinical studies
• Qualify for 3 or 5 years of market exclusivity
• May be eligible for orphan drug or pediatric exclusivity
• May receive an “AB” substitutability rating in the Orange Book

What type of information can an applicant rely on?
FDA’s finding of safety and/or effectiveness for one or more listed drugs that includes approved product labeling, and product-specific published literature. OTC monograph establishing conditions under which the drug is GRAS/E. Published literature that includes non-product-specific published literature.

What CMC Information is required?
The 505(b)(2) application should contain a full description of the chemistry, manufacturing, and controls (CMC) information.
• Drug Substance: Physical and chemical characteristics, manufacturer, method of synthesis and purification, process controls, specifications, and stability.
• Drug Product: Components, composition, specifications for each component, manufacturer, description of manufacturing and packaging procedures, in-process controls, specifications, and stability

Are nonclinical and clinical studies required for a 505(b)(2)?
Many 505(b)(2) applications do not require the sponsor to conduct nonclinical studies. In these cases, the successful application will contain adequate evidence of safety for the proposed product. This may include clinical data, nonclinical studies reported in the literature or approved product labeling, or other justification of why the product is safe for its proposed use.

The requirement for clinical studies will depend on various factors, including how different the proposed product is from the existing product, including indication, dosage, route of administration, and type and quality of the information available in the literature or in approved-product labeling.

What is the content of 505(b)(2) application?
The 505(b)(2) application should be organized in accordance with the “Common Technical Document” (CTD) format:
• MODULE 1: Mostly administrative information
• MODULE 2: Summaries of the information provided (in full) in the remaining modules. This includes a quality-related subsection called the Quality Overall Summary (QOS) and provides high level overview of critical information
• MODULE 3: Quality for drug substance(s) and drug product
• MODULE 4: Preclinical
• MODULE 5: Clinical

What are the major challenges of 505(b)(2)?
• Delay in approval process due to patent or exclusivity protection on the reference drug.
• Determining what additional information is needed to support the proposed change of the previously approved drug.
• Delay in availability of stability studies for new drug.
• Conducting the appropriate CMC bridging study than can show that the change in formulation doesn’t affect the safety and efficacy of the drug.

by TimGDixon » Sun May 07, 2023 6:58 am

Codycrusher wrote: ?Sun May 07, 2023 6:47 am
Won’t the trial on ctdg also be updated every time you treat a patient so patient 1 we will know when he or she is treated and than patient 10 it will be updated Everytime you finish treating a patient, but I am curious will you be updating us on the patient treatment status successful or failure as the trial is ongoing or will that be a all at once update regarding treatment status once all patients are treated and than you file for BLA;;;


Cody we will provide whatever the reg's require us to but there will be no specific patient detail. These are critically ill patients and have at best 2 or 3 days to turn around or they die. This isn't cancer. In the phase 2b we had a very high survival rate of 100% in patients under 85 and 91% over 85. Why? Two reasons; 1) a patient died of cardiac arrest (87yrs old, with cardiovascular disease, mechanically ventilated in ICU in acute lung failure) and the other also over 85 discharged himself 7 days after 2nd transfusion and because he was not there to meet end point of 28 days his data was censored.

The published final results is all that matters because no conclusions can be made until after end point is reached and data analyzed so we all wait together. Keep in mind that somewhere around 38-40 of the 64 placebo patients will die. Of the 40% we anticipate surviving on standard of care, 30% of them will suffer traumatic brain injury.
https://forum.therapeuticsolutionsint.com/viewtopic.php?f=2&p=19116#p19116

MEANWHILE TSOI GOOD NEWS! back biting put aside for a moment...
“We have numerous physicians eager to join the new trial, including ones who have previously witnessed significant patient improvement in previous clinical uses of our cells.”
https://www.businesswire.com/news/home/20230420005538/en/

by TimGDixon » Thu Apr 27, 2023 6:36 am

Very pathetic stats coming from both stocktwits and ihub. We generate the bulk of our vists by direct access not through the spun crap the targets of our case attempt. It goes to show no one is paying attention to either of them, and yet on average we have 600+ visits an hour.

peeps are not living in the brain of IHUB either rent free or otherwise

What it means is peeps are not getting info from IHUB or ST and going to the TSOI site.

by TimGDixon » Fri Mar 03, 2023 7:46 am

curncman wrote: ?Thu Mar 02, 2023 11:12 pm
TimGDixon wrote: ?Thu Mar 02, 2023 1:00 pm
curncman wrote: ?Thu Mar 02, 2023 6:04 am
Tim while you guys are waiting for guidance from FDA , do you think we are close enough to get green signal on the stemvacs breast cancer trial and campbell cell phase 3 trial and also can we get kicked started with a dozen QM trials with money from GHS inc?
The breast cancer IND is now with RENO who is currently raising money for additional animal studies so it will be after those are completed. This is brand new technology and although we have our own preclinicals done to satisfy filing, FDA wants additional (thats pretty standard). We are deciding on QM's future so don't have anything to tell you there. GHS money can be used for any lawful purpose.
Thanks Tim for your clarifications. we wish you can sell other IPs for a handsome sum so that we can buyback shares of TSOI and invest in conducting more clinical trials
You're welcome... I'm with you on that.

by TimGDixon » Fri Apr 21, 2023 9:12 am

Codycrusher wrote: ?Fri Apr 21, 2023 9:11 am
TimGDixon wrote: ?Fri Apr 21, 2023 8:22 am
No that IND is in process and we have placed it with Breathe. We will supplement Breathe with phase 3 data from ARDS and before actually starting phase 1/2b upgrade to phase 3 - watch.
cablejohn45 wrote: ?Fri Apr 21, 2023 8:18 am
Tim is TSOI going to file again for a new IND for COPD?
-- On the 23rd of May we announced receiving IND number 28508 from the FDA for our proposed clinical trial evaluating the JadiCell in treatment of COPD. --

context;
"On May 02 we reported launching the Phase III Trial. A week later on the 9th we announced filing of a new IND seeking permission to treat 10 patients with advanced COPD using JadiCell. On May 12th we told you about new data demonstrating enhancement of the therapeutic activities of the JadiCell through induction of a specific cell type called myeloid derived progenitor cells. On the 23rd of May we announced receiving IND number 28508 from the FDA for our proposed clinical trial evaluating the JadiCell in treatment of COPD."
from;
So are you saying that you are going to use the data from phase 3 once it’s completed and upgrade breath biologics, that is for COPD and upgrade it to a instant phase 3 once phase 3 ARDS is done and commercialized? That would be HUGEEEE
Thats what I am saying... breathe becomes phase 3 clinical stage co.

"COPD is a stand-alone investigational drug application ( https://breathebiologics.com/index.php/clinical-trial/ ) that has nothing to do with the covid-19 ARDS trial other than both INDs reference the same drug master file but not the same source for the investigational product."
"What I am saying is JadiCell LLC's Master Cell Bank One is not the only source of clinical grade cells."

ARDScells Phase 3 ----NEW!
Phase IIb/III Trial of Umbilical Cord-derived Mesenchymal Stem Cells for Patients with Acute Respiratory Distress Syndrome
(IIb/III UC-MSCs for ARDS)

This is a double-blind, phase 2b/3, randomized, controlled, multi-center trial of 128 subjects with moderate to severe ARDS. Allocation to UC- MSC treatment group or control group will be based on 1:1 randomization: 64 subjects will be allocated to UC-MSC treatment group, 64 subjects to control group. Randomization will be stratified by site and by type of oxygen therapy (High Flow Oxygen/NIPPV versus mechanical ventilation). The study will test the hypothesis that UC-MSC treatment leads to an increase of the proportion of patients alive and free of respiratory failure at day 60 after randomization. The study will also estimate effects on survival, on the occurrence of Serious Adverse Events (SAEs), and on time to recovery.

REDUCTION OF NEUTROPHIL EXTRACELLULAR TRAP FORMATION BY MESENCHYMAL STEM CELLS AND THEIR EXOSOMES
Publication number: 20230107484

Abstract: Disclosed are methods of reducing lung inflammation in acute respiratory distress syndrome elicited by various factors such as COVID-19 infection by reduction of neutrophil extracellular trap formation through administration of mesenchymal stem cells and/or exosomes thereof. The invention provides means of inhibiting neutrophil release of extracellular traps by mesenchymal stem cells and/or exosomes derived from said mesenchymal stem cells. Additionally, synergies are provided between mesenchymal stem cells and/or exosomes derived from mesenchymal stem cells and agents approaches which reduce neutrophil extracellular trap formation.

https://therapeuticsolutionsint.com/pipeline/

by TimGDixon » Thu Apr 20, 2023 6:33 pm

Let me help you all understand something. The Phase 3 IND approved to treat covid-19 ARDS is based on scientific evidence that the msc's that were used in phase 2b were garden variety msc's of unknown tissue origin. That is they expressed >90% of CD90 and CD105 and <10% of CD34 and CD45. That data is all contained in the drug master file of which we own the exclusive rights for lung and brain we are able to apply all that clinical data to our own IND's just as we have done with CTE and COPD and as we will do with all others in the future. We're not relying on anything but the clinical data already available to us in the DMF.

and

30 DAYS FROM TODAY--

ARDScell
The USA has the very best medicine and standard of care in the world and our very best can only save 4 out of 10 people diagnosed with ARDS. And of the 40% that survive, 30% of them will suffer a traumatic brain injury. We are going to become the standard of care, and ARDScell we hope will be in every hospital that treats ARDS patients.

And TSOI can make Jadicells

yes true you have no reason to say otherwise Excelsior!

Let’s take a look at a few recent case studies involving the use of JadiCell
TSOI makes their own licensed Jadicell

FDA has the data they have approved once and will do so again everybody but you knows this

key word "its" this is to be a new trial---Therapeutic Solutions International (TSOI) announced today filing of a new Phase III clinical trial application with the FDA for use of its JadiCell adult stem cells in treatment of acute respiratory distress syndrome (ARDS)

Can u read? the jadicells come from TSOI not MU

Let’s take a look at a few recent case studies involving the use of JadiCell
https://veltmeyerinstitute.org/medical-miracle-stem-cells/

another no name though you want to call them up?
https://www.businesswire.com/news/home/20221024005539/en/Therapeutic-Solutions-International-Announces-Successful-Treatment-of-Epilepsy-in-Animal-Model-and-Complete-Cessation-of-Seizures-in-Treatment-Resistant-Patient

Here's one ALS