First Effective Treatment Imminent

dachopper

Super Anarchist
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I've been doing some research on the potential ways out of this lockdown mess and back to normality, and discovered the little Aussie company that could ( Mesoblast ) - are in the middle of a US trial that looks like it's as close to a guaranteed done deal in reducing Covid caused deaths as you can get before a trial end date. They have a treatment of cells that they were in the final  stages of getting approved for use in the USA targeting steroid refractive Graft verses Host disease - which there is no treatment for, and has all ready shown fantastic results ( GVHD is where your own immune system attacks / kills you after receiving a transplant. Steroids are the only treatment but they do not work in about 40% of cases   ). 

As it turns out - the main killing mechanism they observe from Covid , appears to be the Hyper immune response, and the body killing itself also ( cytokine storm ).

So far they have treated 12 people on compassionate grounds who were seriously ill, on ventilators, some with multiple organ failure, some on ventilators for 2 weeks solid prior to being treated, and had a recovery rate of 83% or 10 / 12 people.. The recovery rate in the hospital during that same period for ventilated patients was under 12% ( 88% died ).

They are now about 1 week into the final trial that is necessary to prove that the treatment works, as a proper medical trial with patients getting treated with maximum care standard + either placebo or the cells. The trial has a primary endpoint of survival at 30 days, and also at 7 and 14 days along with other measurements. 33% of the way through the trial, if it is observed that the treatment is overwhelming effective ( which is expected by the compassionate use and other data ) - Then the FDA can approve immediate treatment before the trial has completed.

What is interesting is that Mesoblast by co-incidence were already ramping up production of the cells massively in preparation of their US product launch Ryoncil, and they have stated that they are in a good position to be capable of treating as many critical patents as is needed.

They also have some different cells that are completing their last phase 3 trial next month for lower back pain ( disc regeneration ) / and heart failure which also both look like they are primed for excellent results. 

If they show with the large trial what they did with the 12 critically ill patients, then we are going to be reducing COVID deaths to a level lower than seasonal Flu.... Also the product can treat seasonal Flu aswell..... Fingers crossed we here good news by the end of the month. or some time in June.  

 

Miffy

Super Anarchist
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The “little” company is publicly traded on NYSE and has a capitalization in excess of 6 billion and sort of has a lengthy history of phase 2/3 trials that peters out. 

what I’m saying is... a lot of pharm companies are funding trials then leaking the news during this time to prop up stock values 

so hold yer horses - 

 

El Borracho

Sam’s friend
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Pacific Rim
Can I buy this stock using the Hydroxychloroquine futures I bought a few weeks ago? The future contracts are printed on super high quality paper so should be worth something.

 

dachopper

Super Anarchist
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Do you know how long FDA will insist trials go for?? 
Yep, minimum of 30% completion. There is only 1 primary end point which is 30 days survival. So I imagine once 100 people have clocked over 30 days, which is about the end of the month or in June...If the results are good, they will approve it for immediate use. They already have safety data from over 1000 patients and it has no known side effects from the other phase 3 tests it has completed.

The maximum time frame I have seen is 3 to 4 months for completion for the entire trial for all patients, that is because there are secondary end points which are 90 days ( 3 months ) 

, but this is no  Hydroxychloroquine  or remdisvere.... it actually works so far, I'm expecting they will announce results as soon as they are at the 30 day mark.   If they say nothing in May / June it means the results are not overwhelming and they need the full trial.

 
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dachopper

Super Anarchist
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The “little” company is publicly traded on NYSE and has a capitalization in excess of 6 billion and sort of has a lengthy history of phase 2/3 trials that peters out. 

what I’m saying is... a lot of pharm companies are funding trials then leaking the news during this time to prop up stock values 

so hold yer horses - 
True.... .But the back story behind the failures which I have been looking at, is what is going to make it one of the biggest biomed success stories of the next 5 years without treating COVID, it just so happens that their product is perfectly positioned to treat any viral lung damage causing disease. 

If your interested, then have a look at the phase two primary end points, and what the phase 3 primary endpoints and inclusions are.... You can see they are lined up to succeed   

 

jack_sparrow

Super Anarchist
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, it just so happens that their product is perfectly positioned to treat any viral lung damage causing disease
Except it is not just a traditional respiratory disease but also cardiovascular ie. clotting and depleted O2.

 
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dachopper

Super Anarchist
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Except it is not just a traditional respiratory disease but also cardiovascular ie. clotting and depleted O2.
Their other product Revascor is targeted at heart regeneration, and demonstrated a  reduction in gastrointestinal (GI) bleeding and related hospitalizations.... In fact at the 3 year mark post treatment, the patients that received their stem cells had 0 ocurances of Heart Failure events afterwards, compared to 33% in the placebo group. the Clotting and depleted o2, is all related to the same thing which is the Cytokine storm, and these cells, stop that storm, and enable normal 02 respiration by clearing out the fluid- and promote tissue repair instead of tissue scarring. 

Think about it..... why are most kids not effected...... it's because they have a lot more of these cells...... as you get older you have less and less. Significantly less when you are over say 60 or 70.

The nurses that administered the doseage to those initial 12 patients said within 4 hours there were substantial improvements in their indications. These people were knocking on deaths door before hand, and being mechanically ventilated.

They didn't give the treatment to "any " ventilated patients either - they selected patients who had heart problems specifically as these have proven one of the biggest contributers to death. In the trial they are only accepting patients who have just come onto ventilators, which means if anything there should be an increase in efficacy.

Thats my 2 cents anyway. 

 

Chasm

Super Anarchist
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Can I buy this stock using the Hydroxychloroquine futures I bought a few weeks ago? The future contracts are printed on super high quality paper so should be worth something.
Super high quality you said? I forecast an increased earning capacity for a plumber near you if used as TP substitute. Especially if that blockage occurs outside of business hours...

More on topic it very much depends how the trials go. Blind trial or not? Can the results be repeated at another hospital? Time will tell.
This is one of the big things that the lockdowns buys, time to find out how to (not) treat the disease.

 

El Borracho

Sam’s friend
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Pacific Rim
More evidence out there of a classic Pump & Dump than evidence of treatment efficacy. And this little quote:

"...a bet on [MESOBLAST] is a bet against Moderna (MRNA). Which makes it a bet against Bill Gates, the US Military, Merck and host of other big names."

However, why Pump it on SA? Why indeed @dachopper?

 

Miffy

Super Anarchist
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I’m not a complete cynic - but when “news” gets pushed as the trial starts and before there is efficacy? And there’s no FDA results?

i look at finance pukes with no ethics looking to make a buck. 

 

Miffy

Super Anarchist
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There's plenty of info on this if one is prepared to look

It is more promising that any thing Trump has suggested........
That’s a very low threshold. 
 

Again I’m not saying this won’t end up being effective- but clinical trials are funny things in that neither the care providers or the trial managers have any knowledge of its efficacy and the double blind process virtually ensures that “promising leaks” come from non clinical people. 
 

so... who leaks this shit before it is commercially viable? Finance types. 

 

PHIRKIN

Member
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Kizmaiz
More evidence out there of a classic Pump & Dump than evidence of treatment efficacy. And this little quote:

"...a bet on [MESOBLAST] is a bet against Moderna (MRNA). Which makes it a bet against Bill Gates, the US Military, Merck and host of other big names."

However, why Pump it on SA? Why indeed @dachopper?
Imagine what we'd be looking at if Theranos was still ongoing.  No doubt there are some smaller, younger relatives.

 

EYESAILOR

Super Anarchist
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In case anyone is seriously interested in this topic........

1. Cytokine storms are a serious issue associated with critical CV19 cases bu by no means the only issue.

2. We are having some very good results mitigating Cytokine storms by using extracorporeal cytokine adsorbers. In effect we pump the blood through a sophisticated filter to filter out a high proportion of the cytokines. The device we are using is Japanese with filter from a German company.  Interestingly the Germans are having a lot of success with a similar filter provided by US company . The German mortality rate with critical patients is enviable. 

Anyway, we are impressed by the extracorporeal cytokine adsorbers and we are keen to get our hands on the US version.  Simple and effective.

Therapeutic treatments with drugs which attack the protein might be effective but we are a long way away from seeing them and I would question if they would have a sufficiently fast response time. We dont get a lot of warning so you would have to treat proph

 
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