Can Always Ask Tim

This forum is to discuss general things concerning TSOI.
DailyStockProspector
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Re: Can Always Ask Tim

Post by DailyStockProspector »

Thanks for the reply and insight Tim. It looks Covid and variants will be with us as part of life for a while.
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TimGDixon
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Re: Can Always Ask Tim

Post by TimGDixon »

Thats the present situation I think. The entire world of pharma has been focused on the current generation of vaccines, which have proven to be less effective over time. We think a lot differently than they do. ( https://pdfaiw.uspto.gov/.aiw?PageNum=0 ... 0210393681 )
DailyStockProspector
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Re: Can Always Ask Tim

Post by DailyStockProspector »

So very cool! You guys are amazing.
Go team TSOI (TSI)!
curncman
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Re: Can Always Ask Tim

Post by curncman »

TSOI has potential to come up with STEMVACS-V dendritic non-mRNA vaccine to cure SARS-COV2 epidemic with no side effects with NO booster SHOTS how about that Tim?

With recent patent approval on NANOSTILBENE and QUADRAMUNE can we expect WORLDS first non-mRNA dendritic based vaccine to CURE SARS-COV2 epidemic? :roll: :roll: :roll: :roll: :roll:

Peeps have no clue (EXCEPT the BIGPHARMA) about the significance of recent patent approval for NANOSTILBENE and QUADRAMUNE > SHORTS ARE BURIED NOW :o :o :o :o :o :o :o :o :o :o :o
curiousman
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Re: Can Always Ask Tim

Post by curiousman »

Yeah about that Mesoblast failing their phase 3 trial which they rushed headlong into.

So the phase 2 trial for covid 19, 83% survived https://investorsmedia.mesoblast.com/st ... 71d2c71460

These are the results for the phase 3 trial
"Remestemcel-L reduced mortality through day 60 by 46% in the pre-specified group below age 65, but not in patients 65 or older. Remestemcel-L reduced mortality by 75% and increased days alive off mechanical ventilation in patients under age 65 when combined with dexamethasone, in comparison with controls on dexamethasone." https://www.globenewswire.com/news-rele ... Trial.html

So apparently during the phase 2 trial, 11 of 12 patients were younger than 65, where as in the phase 3 trial a large portion were older than 65, and well Mesoblast's bone marrow derived mesenchymal stem cells don't work so well for people older than 65. So that's why Mesoblast did so well in the phase 2 trial but then bombed during the phase 3.

So Tim how many people were over the age 65 during the phase 2 trial for JadiCell? How was it possible for Mesoblast to do so well in the phase 2 but then absolutely bomb during the phase 3, what is your professional opinion on why they failed? Mesoblast used 18 year old bone marrow MSCs while TSOI is using umbilical cord MSCs, what are the advantages of using the latter? Please go into detail?
curncman
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Re: Can Always Ask Tim

Post by curncman »

just my suggestion to Curiousman, I think this forum is only meant for TSOI products and science behind them. I don't think its proper for Tim to comment on MESO trial or their products as MESO management would know first hand about their trial results and data and so forth!

Please give time to the management of TSOI to execute their plans and initiate and conduct the trial hopefully soon. Moreover these questions you are posing are very confidential in nature given the competitive landscape and surrounded by lot of NDAs , it will be little over enthusiastic on our part to expect Tim to go into any further details.

Sorry Curiousman if i have jumped ahead of myself in expressing my personal views on your post. thanks Hope your questions gets answered
lampspost
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Re: Can Always Ask Tim

Post by lampspost »

Yes I am getting a little curious about curiousman. Asks a lot of questions that Tim can't or shouldn't answer. Maybe I have been reading the stock boards to much but it is getting close to not passing smell test in my opinion.
DebG53
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Re: Can Always Ask Tim

Post by DebG53 »

He sounds "curiously" like Cody IMHO.
Be Blessed, everyone. The future looks great.
Debbie
lampspost
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Re: Can Always Ask Tim

Post by lampspost »

Exactly
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TimGDixon
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Re: Can Always Ask Tim

Post by TimGDixon »

Here are the patients in phase 2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046040/ We are not concerned about MESO nor do I have time to explain why.

Acute respiratory distress syndrome (ARDS) in COVID‐19 is associated with high mortality. Mesenchymal stem cells are known to exert immunomodulatory and anti‐inflammatory effects and could yield beneficial effects in COVID‐19 ARDS. The objective of this study was to determine safety and explore efficacy of umbilical cord mesenchymal stem cell (UC‐MSC) infusions in subjects with COVID‐19 ARDS. A double‐blind, phase 1/2a, randomized, controlled trial was performed. Randomization and stratification by ARDS severity was used to foster balance among groups. All subjects were analyzed under intention to treat design. Twenty‐four subjects were randomized 1:1 to either UC‐MSC treatment (n = 12) or the control group (n = 12). Subjects in the UC‐MSC treatment group received two intravenous infusions (at day 0 and 3) of 100 ± 20 × 106 UC‐MSCs; controls received two infusions of vehicle solution. Both groups received best standard of care. Primary endpoint was safety (adverse events [AEs]) within 6 hours; cardiac arrest or death within 24 hours postinfusion). Secondary endpoints included patient survival at 31 days after the first infusion and time to recovery. No difference was observed between groups in infusion‐associated AEs. No serious adverse events (SAEs) were observed related to UC‐MSC infusions. UC‐MSC infusions in COVID‐19 ARDS were found to be safe. Inflammatory cytokines were significantly decreased in UC‐MSC‐treated subjects at day 6. Treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), SAE‐free survival (P = .008), and time to recovery (P = .03). UC‐MSC infusions are safe and could be beneficial in treating subjects with COVID‐19 ARDS.

Twelve subjects were randomized to the UC‐MSC treatment group (age 59 ± 16 years; 7 women [58%]) and 12 to the control group (age 59 ± 12 years; 4 women [33%]) (Table ​(Table1;1; Table S2). The age of enrolled subjects was 59 ± 14 years (mean ± SD).

A total of nine deaths were documented by day 28 after the second infusion. Two deaths occurred in the UC‐MSC treatment group and seven deaths in the control group. One subject (Subject #11) in the UC‐MSC treatment group died as a result of a failed endotracheal intubation. This outcome was deemed to be unrelated to the patient's COVID‐19 disease. Therefore, data analyses for this subject were censored at the time of failed endotracheal intubation.

Two cases required special considerations. Subject #11 died for reasons unrelated to COVID‐19 after failed endotracheal intubation. Therefore, this subject was considered as censored in the data analysis for time to COVID‐19‐related death and time to recovery outcomes. Subject #24 left the hospital against medical advice 11 days after second infusion and was thus considered as censored in the time to recovery analysis. This patient eventually recovered at home and was confirmed alive at 31 days after the first infusion.

The primary endpoint was safety, defined as the occurrence of prespecified infusion‐associated AEs within 6 hours after infusion in addition to cardiac arrest or death within 24 hours after infusion. Prespecified infusion‐associated AEs are outlined in Table ​Table3.3. One subject in each group developed infusion‐associated AEs. UC‐MSC treatment was found to be safe, as it did not lead to an increase in prespecified infusion‐associated AEs. In the UC‐MSC treatment group, the only reported adverse event occurred in a subject with bradycardia, who experienced worsening of bradycardia and required transient vasopressor treatment. In the control group, all prespecified infusion‐associated AEs occurred in the same subject, who experienced cardiac arrest 2 hours after infusion of vehicle solution. In each group, one subject developed infusion‐associated AEs.
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