Welcome back!!

[TimGDixon]

There can only be Peace through Victory for Ukraine!!! Long Live Ukraine!

[Codycrusher]

Apparently some investors are making a group to write letters to the SEC against you and I have heard a few of them already has, probably more than once I am assuming, that costs you money and everything and you time Tim when you got nothing to hide all of us know, you just have ceo laws you have to abide by and most of us understand that.
What I am wondering is this, are you privileged to the sort of information of knowing what specific people by name wrote those letters to the SEC so you can hold them legally accountable down the road?
That is a serious offense for investors to write letters the SEC to waste your money and time and I think they should most definitely be held accountable for trying to jeopardize this company, but without you knowing who wrote the letters by name, you really wouldn’t have much evidence to hold them accountable to so I was wondering if you were privileged to the names of the individuals who writes letters to the SEC about TSOI and you with false and untrue information.

[TimGDixon]

I am not aware of any current letters or complaints being sent/filed to SEC. Back in May 2020 at the beginning of the pandemic - in fact on the day I filed this Granted Patent https://patents.justia.com/patent/11266707 a bunch of people did write letters apparently because we had to spend in excess of $10,000 to answer enquiries by SEC and FINRA concerning said patent and what did it get them? Nothing.

Cody these people are all full of doo-doo..... Ignore them and their "threats" - bunch of pathetic losers is what they are. You just hang in there and don't let those people rile you up, but thank you for defending TSOI out there.

Apparently some investors are making a group to write letters to the SEC against you and I have heard a few of them already has, probably more than once I am assuming, that costs you money and everything and you time Tim when you got nothing to hide all of us know, you just have ceo laws you have to abide by and most of us understand that.
What I am wondering is this, are you privileged to the sort of information of knowing what specific people by name wrote those letters to the SEC so you can hold them legally accountable down the road?
That is a serious offense for investors to write letters the SEC to waste your money and time and I think they should most definitely be held accountable for trying to jeopardize this company, but without you knowing who wrote the letters by name, you really wouldn’t have much evidence to hold them accountable to so I was wondering if you were privileged to the names of the individuals who writes letters to the SEC about TSOI and you with false and untrue information.

[Codycrusher]

Hey Tim, I wonder, is there anything planned for the future for stemvacs because I remember you talking about awhile back about wanting to do a phase 1-2 and haven’t heard about it in awhile, and I understand you can’t talk about EUA or phase 3 because of nda on jadi so I won’t ask, I’m just wondering about stemvacs currently because it’s a cancer treatment and cancer is HUGEEEE, stemvacs would bring a lot of attention to TSOI, definitely if it shows signs of being successful in clinical trials.
Stemvacs or stemvacs-V I think you renamed it stemvacs-V

I would be so excited to see that start going and making progress because cancer is a big subject and it could do massive loads for the future of this company definitely if shown signs of being successful through trials.

[TimGDixon]

Hey Tim, I wonder, is there anything planned for the future for stemvacs because I remember you talking about awhile back about wanting to do a phase 1-2 and haven’t heard about it in awhile, and I understand you can’t talk about EUA or phase 3 because of nda on jadi so I won’t ask, I’m just wondering about stemvacs currently because it’s a cancer treatment and cancer is HUGEEEE, stemvacs would bring a lot of attention to TSOI, definitely if it shows signs of being successful in clinical trials.
Stemvacs or stemvacs-V I think you renamed it stemvacs-V

I would be so excited to see that start going and making progress because cancer is a big subject and it could do massive loads for the future of this company definitely if shown signs of being successful through trials.

You may have forgot but we have a filed an IND for Metastatic Breast Cancer. https://therapeuticsolutionsint.com/the ... st-cancer/


StemVacs-V for Metastatic Breast Cancer

The proposed study will assess feasibility and safety of an allogeneic therapeutic vaccine, StemVacs-V comprising inducible pluripotent stem cell (iPSC) derived endothelial-like cells generated under conditions designed to replicate the tumor microenvironment. StemVacs-V is designed to replicate tumor endothelial cells and induce immunity

Numerous preclinical studies in animal models, as well as 2 clinical studies, have demonstrated the feasibility of breaking tolerance to tumor associated endothelium, while not inducing cross-immunity towards healthy endothelium. Previous clinical studies have utilized human umbilical vein derived endothelial cells as a polyvalent immunogen, the current approach is modified in that iPSC-derived endothelial cells are utilized. This modification is performed based on: a) need for consistency of manufacturing; b) significantly higher amount of endothelial cells can be derived from the iPSC source as compared to umbilical cord; and c) ability for future generations of the vaccine to utilize molecular adjuvants. Additionally, the iPSC based StemVacs-V product is different than classical endothelial cell vaccines due to the step of pre-treatment with interferon gamma, which is performed in order to augment immunogenicity of tumor endothelial-like cells.

In the current study we seek to evaluate safety and signals of efficacy of StemVacs-V. Treatment protocol will comprise of 4 administrations of StemVacs-V, once per month, with each administration consisting of 4 separate intradermal administrations of 2.5 million cells in a volume of 1 ml. Therefore total cell dose will be 40 million cells, with 10 million cells administered per month.

[Codycrusher]

Hey Tim, I wonder, is there anything planned for the future for stemvacs because I remember you talking about awhile back about wanting to do a phase 1-2 and haven’t heard about it in awhile, and I understand you can’t talk about EUA or phase 3 because of nda on jadi so I won’t ask, I’m just wondering about stemvacs currently because it’s a cancer treatment and cancer is HUGEEEE, stemvacs would bring a lot of attention to TSOI, definitely if it shows signs of being successful in clinical trials.
Stemvacs or stemvacs-V I think you renamed it stemvacs-V

I would be so excited to see that start going and making progress because cancer is a big subject and it could do massive loads for the future of this company definitely if shown signs of being successful through trials.

You may have forgot but we have a filed an IND for Metastatic Breast Cancer. https://therapeuticsolutionsint.com/the ... st-cancer/


StemVacs-V for Metastatic Breast Cancer

The proposed study will assess feasibility and safety of an allogeneic therapeutic vaccine, StemVacs-V comprising inducible pluripotent stem cell (iPSC) derived endothelial-like cells generated under conditions designed to replicate the tumor microenvironment. StemVacs-V is designed to replicate tumor endothelial cells and induce immunity

Numerous preclinical studies in animal models, as well as 2 clinical studies, have demonstrated the feasibility of breaking tolerance to tumor associated endothelium, while not inducing cross-immunity towards healthy endothelium. Previous clinical studies have utilized human umbilical vein derived endothelial cells as a polyvalent immunogen, the current approach is modified in that iPSC-derived endothelial cells are utilized. This modification is performed based on: a) need for consistency of manufacturing; b) significantly higher amount of endothelial cells can be derived from the iPSC source as compared to umbilical cord; and c) ability for future generations of the vaccine to utilize molecular adjuvants. Additionally, the iPSC based StemVacs-V product is different than classical endothelial cell vaccines due to the step of pre-treatment with interferon gamma, which is performed in order to augment immunogenicity of tumor endothelial-like cells.

In the current study we seek to evaluate safety and signals of efficacy of StemVacs-V. Treatment protocol will comprise of 4 administrations of StemVacs-V, once per month, with each administration consisting of 4 separate intradermal administrations of 2.5 million cells in a volume of 1 ml. Therefore total cell dose will be 40 million cells, with 10 million cells administered per month.

How long does it take for an IND to be granted or are you still in the process of questions from fda and answering questions sort of process until they give you the go ahead for the IND?

[TimGDixon]

Yeah were going to be in back and forth and more animal models mode for a bit - but its still very exciting.

[Codycrusher]

Yep, cancer breast cancer cure would be MASSIVE, I just learned today that 2 years ago GLSI went from 3 dollars to 5 and 5 dollars to 158 on a single breast cancer cure on a OS of 10 million, TSOI has 2.5 million so that would be like a 500 dollar share price for us, could you imagine that? That’s the insane potential of a breast cancer cure and I assume Jadicell also once clinical trials phase 3 is completed once started and finished to commercialization.
Man the future gonna rock.