Correct some confusion

This forum is to discuss general things concerning TSOI.
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TimGDixon
Posts: 1206
Joined: Fri Jun 26, 2020 4:36 am

Correct some confusion

Post by TimGDixon »

I need to set the record straight in respect to StemVacs vs. Stem cells.

StemVacs was originally (and still is and is still viable) an autologous cancer vaccine (autologous means self, as in we produce the vaccine (immunotherapy) from the patients own cells) that completed a Phase 1 clinical trial. It has not advanced beyond Phase 1 because we made the 2nd generation you know as StemVacs-V (iPSC-TEC). So SVV needs to start its regulatory march (yes we can go back and do more on SV version 1) and conduct a Phase 1 which will require an IND to be filed so we are not any further along than that but we are about ready to initiate that work. You see us issue press surrounding this and most of it has to do with us prepping animal studies we know will be asked of us in IND anyways so we're just getting that work knocked out - patience my friends - this is revolutionary stuff and we want to do it right.

Stem Cells is a different thing - we are waiting phase 3 approval of the Jadi Cell, and we are working through IND for CTE right now with FDA - patience my friends - this too is revolutionary stuff and it has to be right.

We do have an option with SVV to conduct a small proof-of-concept trial ahead of IND and buttress our filing with human data on top of the animal data that is required. I personally like this option because its the same thing we did with SV #1 - that IND is still filed and contains both human and animal data (as to safety and evidence of efficacy) and yet FDA asked for more animal data even though we provided data on 10 humans with advanced solid tumor cancers. So in anticipation of the same response we are doing that work now.

So hang in there - we're all just singers in a rock and roll band... about to go on tour...


rrao11
Posts: 135
Joined: Sat Jun 27, 2020 5:33 am

Re: Correct some confusion

Post by rrao11 »

Thanks for the detailed explanation Tim. Makes a lot of sense! Thanks and keep up the great work!
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TimGDixon
Posts: 1206
Joined: Fri Jun 26, 2020 4:36 am

Re: Correct some confusion

Post by TimGDixon »

Thank you Rrao... we're not counting on "lucky stars" but we think 1000 stars have aligned in a lovely way...


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