Rich Carson's advert/hype of a new drug treatment for ME.

[Murph]

Maybe a drug company that has got a drug through a Phase 1 safety trial is now being trialled in other conditions? The odds of it working for me/cfs are probably slim so I think the hype is unjustified, but still, there is some modest reason for hope.

Perhaps it failed its phase ii efficacy trial on the intended target and now they are branching out to see if they can recoup some money by seeing if it works in other, related conditions. Rather than being annoyed at the small sample size, I'd say that's a good feature of an early phase trial on humans. If I was an ethics committee, I'd approve only a small trial to start.

The PR blitz is weird, but the inclusion of Jarred Younger makes me moderately more confident. It does seem quite possible the company is trying to go public to raise capital to keep going. They may have a safe, innovative, peptide that narrowly missed its primary endpoints in another trial and they now need $$ to not go bankrupt.. That's just business, - it doesn't prove the drug won't be helpful in other conditions!

EDIT 2: here's some more detail on the corporate structures: Seems the drug is IP that was sold off from a big company to a start up. "Hi Anne, the company is a start up pharmaceutical company, so there is no stock symbol. The drug was developed by a $700m company that was owned by a much larger company. We have articles coming out soon on the story, so stay tuned."

The big news here maybe is that a start-up recognises that there may be a market for a CFS cure! That's a great sign.

EDIT 1: making me lose a bit of confidence is this claim by Rich Carson in the facebook feed that they've developed an 'animal model of cfs':

"Exposing the rats to tremendous stress. They never recovered. Developed symptoms similar to those in ME--lower body temp, increased heart rate, decreased blood pressure, decreased movement--and they did not recover, until the drug was administered."

 

[Sushi]

The PR blitz is weird, but the inclusion of Jarred Younger makes me moderately more confident.

Just a quick look at Younger's site and Lapp's site, don't mention any public discussion of this. Unless it is a private conference call.

 

[alex3619]

I suspect that with Chronic Lyme they are working on a model for a subset in which the pathogen is cleared but there are changes to the brain that keep the symptoms going. This line of research will require a lot of further studies to be validated, though they might be interested in cutting through that process by directly trialing it on patients.

 

[hixxy]

making me lose a bit of confidence is this claim by Rich Carson in the facebook feed that they've developed an 'animal model of cfs':

"Exposing the rats to tremendous stress. They never recovered. Developed symptoms similar to those in ME--lower body temp, increased heart rate, decreased blood pressure, decreased movement--and they did not recover, until the drug was administered."

Doesn't sound very promising.

 

[Murph]

Could there be a small chance the subcutaneous peptide in question is Ersatta?

It was developed by a US company called cebix. it shut down after its phase ii trial which showed results, but the placebo group improved too so there was no difference.

http://www.xconomy.com/san-diego/20...following-mid-stage-trial-of-c-peptide-drug/#

The drug was designed for diabetes and mostly has peripheral effects but early research on it showed some central nervous system effects.

https://www.ncbi.nlm.nih.gov/pubmed/20039010/

 

[duncan]

I suspect that with Chronic Lyme they are working on a model for a subset in which the pathogen is cleared but there are changes to the brain that keep the symptoms going.

Technically, this would qualify the condition as Post Lyme Disease Syndrome. That they are not familiar enough with the proper terminology does not help instill confidence.

I cannot help but feel like they've aligned their sights towards a certain cluster of controversial or orphaned diseases.

I'm also not thrilled by the trio they selected to discuss the product.

 

[Alvin2]

The only heightened state of arousal here is the BS alarm going off in my head.

 

[barbc56]

Pure scam. Leading researchers and clinicians have never heard of this and are unlikely to want to. The guy cannot even write good English. It annoys me that we live in a world where it is acceptable for people wanting to make money out of other people who are sick are allowed to do pretty much say they like.

What is the alternative?

GG

Ethics and Science.

 

[Marky90]

Im sending Karl

 

[barbc56]

I can't get to the facebook link. It says either the site is private or the information has been removed. I am signed into Facebook.

 

[Murph]

I can't get to the facebook link. It says either the site is private or the information has been removed. I am signed into Facebook.

looks to have been taken down! seems to justify the doubters doubt.

 

[hixxy]

looks to have been taken down! seems to justify the doubters doubt.

Pretty sure the post was never public. A friend of mine who has Rich Carson added as a friend was able to read it yesterday and I couldn't access the link at the same time.

 

[joshualevy]

This just seems a bit of an odd way of doing things like this to my mind. Don't drug companies normally want to keep their research under wraps to stop competitors from trying to copy them?

Yes and no. Yes drug companies would love to keep everything secret until the last minute, but they can't, for two reasons.

First, any trial used to get FDA approval in the US must be registered at clinicaltrials.gov, and that is public. If your trials are not registered, you can not submit them to the FDA to get approval. Companies try all sorts of things to keep a low profile. I've seen code names, vague descriptions of diseases, treatments, and symptoms, and all kinds of other techniques to make it hard to know who is doing what. But at the end of the day, there must be something there.

Second, a lot of drug companies, especially the smaller ones, need to raise money, and this often requires some kind of publicity.

 

[aquariusgirl]

So this Ersatta that is referenced above ......could it in any way be linked to the issues with pyruvate dehydrogenase?

Is there a connection between PD dysfunction & insulin resistance?

JaimeS was just asking for patients to share results of their insulin tolerance tests so Prof Davis is looking at insulin problems I guess right?

 

[Valentijn]

An injectable experimental peptide? I really doubt it. This has FDA implications.

4ME/Nexavir/Kutapressin is an injectable peptide, and typically doesn't require a prescription. Basically it's just a liver extract, and I suspect this guy is talking about something similar.

A "peptide" is just two or more amino acids, and could be pretty much anything. Due to the variety of conditions listed, it's probably being vaguely promoted as an immune modulator. In which case, it would have a mild impact on downstream symptoms at best, and certainly would not be any sort of cure, and would be unlikely to reduce disability.

 

[barbc56]

4ME/Nexavir/Kutapressin is an injectable peptide, and typically doesn't require a prescription. Basically it's just a liver extract, and I suspect this guy is talking about something similar.

A "peptide" is just two or more amino acids, and could be pretty much anything. Due to the variety of conditions listed, it's probably being vaguely promoted as an immune modulator. In which case, it would have a mild impact on downstream symptoms at best, and certainly would not be any sort of cure, and would be unlikely to reduce disability.

Is this the same as neural therapy?

 

[AndyPR]

Pretty sure the post was never public. A friend of mine who has Rich Carson added as a friend was able to read it yesterday and I couldn't access the link at the same time.

It must have been either public or perhaps "friends of friends" as I'm not a friend of his on Facebook but was able to read it yesterday. I would guess, as @Murph suggests, it's either been taken down or privacy changed.

 

[Valentijn]

Is this the same as neural therapy?

No

 

[Undisclosed]

It must have been either public or perhaps "friends of friends" as I'm not a friend of his on Facebook but was able to read it yesterday. I would guess, as @Murph suggests, it's either been taken down or privacy changed.

It was also tweeted by Rich Carson. His FB page is public. The post has been removed.

 

[barbc56]

I didn't have the energy to look this up. Then I did and saw I was on the wrong track. Just send me the bill.

No