Bhupesh Prusty: "we are on a perfect path for identifying potential transferable factors in ME/CFS blood that can cause mito dysfunction..." GoFundMe

ljimbo423

ljimbo423

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Rufous McKinney said:
Is this saying those Phase 3 trials failed?

https://www.biopharmadive.com/news/stealth-phase-3-setback-elamipretide-alexion/569521/
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This quote is from that link-

Treatment with Stealth's drug, a peptide called elamipretide, didn't appear to benefit patients with an inherited disease characterized by dysfunctional mitochondria,
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I think it's an antioxidant peptide, if I remember right. Which might not work in inherited disease. ME/CFS on the other hand, is well known for causing high levels of oxidative stress. Which elamipretide might help with.
 
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raghav

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babeng said:
I'm speculating here, but maybe Ron doesn't agree with Prusty's HHV-6 theory. He has stated numerous times that they don't find viruses in the blood, and that you should be able to detect them there.
Naviaux is on the SAB of OMF though, so a bit weird.
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In Prusty's presentation at the NIH conference in 2019 april he mentions that HHV-6 inserts a 6 nucleotide sequence into the DNA or RNA (Not sure) and that this is not detected by the immune system just like immune system fails to detect most types of cancer because the cells are our own. This 6 nucleotide sequence it seems is common to many viruses and it acts as a trojan horse. I have a gut feeling this causes the mito fragmentation and weakens the cells defence against future viral attacks.

After the Presentation Prof. Jose Montoya stood up and asked the question about this 6 nucleotide sequence and what it codes ? I dont remember the reply Prusty gave. But he said this is key to many mysteries surrounding the stealthy viruses. So the HHV-6 infection or its entire free nuclear material need not be present in the tissue or plasma but still causes problems. I feel this makes the immune system go into attack mode and after some time the immune system gets exhausted and that is why we are seeing ageing of immune cells. This is purely my speculation trying to connect the dots.

ME need not be due to this. Prusty himself said so during the presentation. But the fragmentation of mitochondria is the key to the disease. Since once you starve the cell of energy naturally the cell tries to conserve energy for the essential processes and shuts down or minimizes the not so important processes. This in the long run causes symptoms which are reflective of the individual's genetic defects and weaknesses.This is Naviaux's postulate. That is why when you try to group people according to symptoms and see what the underlying commanality of that particular subgroup is you are not able to see anything of statistical significance.
 
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raghav

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Hopeful1976 said:
I don't understand why OMF are not making comment? I thought their whole ethos was sharing and collaboration to get to the answers of m.e quickly and efficiently. I'm really sad no comment has been made about Prustys amazing discoveries, even more so as it is so in line with the nanoneedle results. Im honestly baffled by this....
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I hope Ron Davis and Prusty can forget all the past differences if there were any and collaborate and bring this monster of a disease/disorder to an end within 2 years. Prusty has said some pre approved FDA drugs are suitable candidates for this problem. So he will need funds to test them out. Then with proof they can approach the NIH for funding. Usually in such cases Phase I will not be required since it is a repurposed drug. Phase II may be required to prove efficacy. Phase III will be the costliest since you have to test it in a large group of 200 - 300 for atleast 6 months.

But if Prusty finds a cure and eliminates the cell danger signal, that blue blob in the picture which is causing the fission then the mito should fuse back on their own. My gut instinct says we may not need suramin to jump start the process. Since it is a energy starvation mode the cells are in and not dauer state naturally the system should reboot on its own. Prusty has said once you remove the ME serum from the healthy cells they fuse back and become healthy the same should apply to ME patients' cells also. Or I may be wrong and it may require a one time push start with suramin. In such a case phase III will not be costly since no maintenance dose will be required. Anyway Prusty has mentioned in one of his tweets we should try and rope in film celebrities and sports persons for funding. So it looks like we will require funds. How much is the question. Anyway the end is near. ;)
 
MonkeyMan

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Hopeful1976 said:
I don't understand why OMF are not making comment? I thought their whole ethos was sharing and collaboration to get to the answers of m.e quickly and efficiently. I'm really sad no comment has been made about Prustys amazing discoveries, even more so as it is so in line with the nanoneedle results. Im honestly baffled by this....
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Also, Cort Johnson has so far not written a blog about this on Health Rising. It's puzzling.
 
MonkeyMan

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Badpack said:
Elamipretide just good fast track fda approval process for barth syndrom today. This means it could be possible that end of the year its commercially available for off label use in cfs. Should it be able to stop mitochondrial fission it could be a top line medication.
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I just don't understand why ultra-rare conditions like Barth Syndrome get priority and generate pharma company attention and ME/CFS does not. As many as 2.5 million Americans have ME/CFS. Barth Syndrome? About 1,000. What the heck is going on here??! Can someone please enlighten me?
 
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babeng

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Badpack said:
Elamipretide just good fast track fda approval process for barth syndrom today. This means it could be possible that end of the year its commercially available for off label use in cfs. Should it be able to stop mitochondrial fission it could be a top line medication.
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Where do you get this timeline? The press release doesn't say anything of the requirements going forward.
 
paul80

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@raghav or anyone else who wants to answer. if it was so hard to isolate this factor from the blood will it not be just as hard to isolate the others? Cause i thought he said there was other factors in the serum that were causing the dysfunction.
 
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Badpack

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@babeng fast track fda approval process means a decision in under 6 months. Following this, we hear from them in early september with a possible launch the month after.
 
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bread.

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Who wrote the grandiose comment from OMF towards Dr. Prusty and were there any explanations?
 
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babeng

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Badpack said:
@babeng fast track fda approval process means a decision in under 6 months. Following this, we hear from them in early september with a possible launch the month after.
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I don’t think this is correct tbh. First, they received a «Rare Pediatric Disease Designation”. It doesn’t seem that this is equal to a fast track designation. This program seems to give other rights. In addition, a fast track designation doesn’t mean a decision in 6 months. Drugs can have fast track for many years. Fast Track designation gives the right to have close contact and discussions with FDA during clinical trials.
My understanding is that even though the designation they received gives the same rights as fast track, which I don’t believe, this news doesn’t say anything about the requirements going forward.

For all we know they will need more studies/patients/longer follow up etc. That’s at least my take on it.
 
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raghav

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paul80 said:
@raghav or anyone else who wants to answer. if it was so hard to isolate this factor from the blood will it not be just as hard to isolate the others? Cause i thought he said there was other factors in the serum that were causing the dysfunction.
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Others did not look at the event of mito fissioning which Prusty alone saw most probably because he has seen this phenomenon in most herpes class of viruses doing it to healthy host cells. So he caught the blue blob you see in the cell picture, right in the act of fissioning the mitochondria and thus was able to point out and say this is it. Others just added the serum to the healthy cells and waited for a fixed period of time and then looked at it and could not see the blue blob (which Prusty has stained after most probably multiple attempts and then narrowed in on the suspect list and stained them all and this one did the fissioning). And moreover people were looking at the mito through the Seahorse instrument which gives a lot of quantitative data but says nothing about the fissioning phenomenon.

Prusty was the first to see the phenomenon of mito fission and fusion because he had the patience to keep looking at the cell intently with the Zeiss confocal microscope. Astronomers call this "Event Horizon" when say for example a giant star is going to explode into a supernova they need to know when it is going to do so. Only then they can catch the mechanics of what is happening. This is what Prusty did. So he saw it. Otherwise the molecule(s) causing this fission simply mingle with the other contents of the cell cytoplasm and then it is like looking for a salt molecule in the ocean. The same molecule may also spread out of the cell into the serum thereby moving into other nearby cells and repeating the act. When sufficient number of cells have shut down then you start seeing symptoms. This is my guess. I think this is where Naviaux's novel cell based assay came in helpful for isolating the molecule(s).
 
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