Trial of CT38 for ME/CFS by Cortene Inc.: big claims being made...

Is it technically possible for someone to be suffering from this form of learned helplessness they speak of, whilst at the same time striving hard to get the best they can out of their life despite their limitations, and refusing to give up.

Is this LH something that can exist at one level within the brain, yet co-exist with very very positive love-of-life indications and refusing to give in?
 
akrasia said:
There will be consequences if a drug that affirms a stress hypothesis is approved for M.E. Perhaps this will happen only in the short term. But I'm not optimistic about that either.
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Yeah I agree, there could be some consequences from this, which would not be good.

However, I'd look at it optimistically this way. Either A) the drug fails to show any effect, in which case their hypothesis is of no concern and can be thrown to the trash can or B) the drug is shown to be effective, in which case, there would finally be at least one approved drug for ME/CFS treatment. So this is a no loss scenario, except if case B) turns out to be true and the drug trial is somehow subject to bias or other issues, a la PACE.

However, I see it much less likely that a trialed drug would end being backed up by a similar methodological mess as PACE. The biggest flaw about PACE that has constantly been pointed out was that it was an unblinded trial, which used subjective outcomes only. In the case of drug trials, the blinded factor is there, so we don't have this problematic of a combination of unblinded treatments affecting the subjective outcome. Finally, there is a huge hurdle for new drugs to ever reach FDA approval, which is why even the big drug companies are failing to develop many new drugs lately. If I had to place my bets, going by the odds, it would be obviously most likely that this drug will either fail to show an effect or fail to ever reach phase 3 trials, due to funding or other issues.
 
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Barry said:
Is it technically possible for someone to be suffering from this form of learned helplessness they speak of, whilst at the same time striving hard to get the best they can out of their life despite their limitations, and refusing to give up.

Is this LH something that can exist at one level within the brain, yet co-exist with very very positive love-of-life indications and refusing to give in?
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When I was involved with abused children many years ago learned helplessness was used to describe the apathy you often found in them. It was described as sitting trying not to be noticed waiting for the next blow to fall.

In adults it could maybe be seen as low esteem or pessimism I suppose but it is probably one of those BPS phrases which sounds good but is so nebulous it can be applied to anyone at any time.

Experiments were done with rats where if you stressed them enough they just gave up but that was in rats who were confined and could not escape the stress they were under. Humans watch some cat videos or have chocolate or alcohol. They have resources to cope not available to rats so while the same outcome could happen under extreme stress, applying it to people who don't know they have it is just wrong.
 
Mithriel said:
When I was involved with abused children many years ago learned helplessness was used to describe the apathy you often found in them. It was described as sitting trying not to be noticed waiting for the next blow to fall.

In adults it could maybe be seen as low esteem or pessimism I suppose but it is probably one of those BPS phrases which sounds good but is so nebulous it can be applied to anyone at any time.

Experiments were done with rats where if you stressed them enough they just gave up but that was in rats who were confined and could not escape the stress they were under. Humans watch some cat videos or have chocolate or alcohol. They have resources to cope not available to rats so while the same outcome could happen under extreme stress, applying it to people who don't know they have it is just wrong.
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Thanks, that explains what I was wanting to understand. Because my wife always impresses me with the way she constantly strives to do stuff, and stay on top of life. She loves her gardening, loves her quilting and related courses, never capitulates. Does she ever get blue about her ME and the thing she can no longer do ... yes of course she does, but it is always transitory and rarely long lasting. The very last thing she ever exhibits is signs of learned helplessness; she always strongly exhibits potent signs of learned self-help strategies. These people seem to just pull these ideas out of their 'arris.
 
akrasia said:
There will be consequences if a drug that affirms a stress hypothesis is approved for M.E.
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I don't really see the big deal, I mean if stress is part of the pathology and the drug works, then fantastic. But we also need to emphasise the reverse, namely if the drug doesn't work, then we need to abandon hypotheses that involve the corticotropin-releasing factor (and glucocorticoid receptor). They can't have it both ways.
 
I read their newsletter this morning. They are waiting to complete the filing of a patent before publishing a peer-reviewed article (review period by the newspaper, 6 months). They cannot yet publish the results because that would influence the reviewers. New placebo test as soon as they have the funds (phase 2), $ 5 million needed. Then move on to phase 3 ($ 7 million required) for FDA agreement. Drug available at the earliest in 4 years in the US.
 
newsletter said:
With the help of Dr. Lucinda Bateman at the Bateman Horne Center, our InTiME trial tested 2-3 subcutaneous infusions of CT38 at 4 different dose-levels in 14 ME/CFS patients. While the trial was completed in April 2019, the publication of results has been delayed due to novel findings that necessitated the filing of a new patent. This should be filed this month and our next objective will be publication.
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'Novel findings' of course could mean lots of things but probably does not mean that Cortene provided a clear benefit in all the ME/CFS patients as was hoped and expected. If I had to bet, I'd go for 'no statistically significant benefit at the whole sample level, but a subset of patients appeared to show some benefit. So the patent is being adjusted to reflect a tighter selection criteria'. In a sample size of 14 patients, any subset is going to be small and could easily be the product of chance and a post hoc investigation of many possible patient characteristics.

Jaybee00 said:
I don't think that they would be proceeding if the drug had demonstrated no positive effect.
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A small Phase 1 trial could not have the drug demonstrating a positive effect - it could suggest a positive effect but it isn't sufficient to demonstrate one. I don't recall what this Phase 1 trial involved, but I doubt that there was much in the way of objective outcomes.

As others have already said, there are reasons why the company might be proceeding to a Phase 2 trial other than Cortene demonstrating an objectively positive effect.
beverlyhills said:
The owner of the molecule may be pumping its value for resale. One way to do this is a performative and non-substantive open-label study, make a press release and get some buzz to increase its right's of manufacture price and sell it to another entity.
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I guess time will tell.
 
Jaybee00 said:
Here is the link to the newsletter

https://cortene.wordpress.com/2020/01/

I don't think that they would be proceeding if the drug had demonstrated no positive effect.
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Pilot studies don't really demonstrate effect, you have to proceed to a larger study if you want to demonstrate effect. The patent is there just in case it has any therapeutic value for any related group of patients, this is standard practise in industry.
 
they are mofos. want to get cheap and free patients money for a very, very, very low chance of success, it is a win win for Cortene.
 
butter. said:
they are mofos. want to get cheap and free patients money for a very, very, very low chance of success, it is a win win for Cortene.
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Patents are not that cheap to write and file, but the real cost is in enforcement...

I've previously stated my opinion on Cortene (that it contradicts existing neuroendocrine findings in CFS patients), so I won't comment further.
 
butter. said:
they are mofos. want to get cheap and free patients money for a very, very, very low chance of success, it is a win win for Cortene.
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Er, aren't all drug companies trying to make money or are there companies offering their products for free? Besides, it is not a win-win at all if phase 2 fails. Developing drugs isn't exactly a guaranteed lucrative business as the risks involved are significant, for example Pfizer recently withdrew from research in developing new Alzheimer's and Parkinson's drugs, probably because the chances of success in this field are so low. ME/CFS is at least as complicated, so I find it curious that when one little company finally shows willingness to trial something, they are labeled as the bad guys.
 
Snow Leopard said:
Pilot studies don't really demonstrate effect, you have to proceed to a larger study if you want to demonstrate effect. The patent is there just in case it has any therapeutic value for any related group of patients, this is standard practise in industry.
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Phase one determines whether a drug is safe to check for efficacy. 70% of drugs pass this step where only 25-30% pass a phase three. So phase one was a success in that they didn't kill anybody!
 
JES said:
Er, aren't all drug companies trying to make money or are there companies offering their products for free? Besides, it is not a win-win at all if phase 2 fails. Developing drugs isn't exactly a guaranteed lucrative business as the risks involved are significant, for example Pfizer recently withdrew from research in developing new Alzheimer's and Parkinson's drugs, probably because the chances of success in this field are so low. ME/CFS is at least as complicated, so I find it curious that when one little company finally shows willingness to trial something, they are labeled as the bad guys.
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I'm not an expert on on Alzheimer's or Parkinson's drugs - this is all from memory. Cort Johnson did an article relatively recently on Alzheimer's drugs (& Parkinson's drugs?). A lot of the drug trials in Alzheimer's stopped because they were focused on Amyloid Plaques - wrong target; postmortems found high levels of plaque in people who were healthy and people who had Alzheimer's. A GWAS study identified inflammation as the potential underlying cause/increasing susceptibility; so possibly the drug companies have re-focused/will re-focus.

The absence of commercially funded work to develop new antibiotics highlights the problem with relying on industry. Industry/commerce is about bangs for buck; cancer drugs are lucrative antibiotics are not. So Obama provided public money to try to deal with this [https://obamawhitehouse.archives.go...tion-releases-national-action-plan-combat-ant].

Potentially ME could be progressed by identifying the something in the blood and re-purposing existing drugs; we don't know enough to say how difficult the problem is --- no biomarkers (indicators of disease target or whatever).

All supposition - I know very little.
 
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