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Solve CFS and Biovista release name of drugs for repurposing

Kati

Patient in training
Messages
5,497
From Solve CFS Newsletter:
http://solvecfs.org/biovista-work-released



In 2012, the Solve ME/CFS Initiative—under its former organization as the CFIDS Association of America—funded Biovista Inc., a private drug development services company, to identify potential drugs that might be repurposed to ameliorate ME/CFS symptoms. Biovista identified two FDA-approved drugs that might have applicability for ME/CFS.

Since the completion of the work, the possibility of raising funds to further develop a treatment based on this combination has been explored. In view of the recent effort for National Institutes of Health funding for ME/CFS, the research and patient community may be better served by making this initial finding known to the public now.

Low Dose Naltrexone (LDN) and Trazodone are the two drugs identified through a bioinformatics analysis as potential treatment in ME/CFS. In its analysis, the company employed Drug Repurposing, the process of finding new indications for existing drugs, to identify compounds for the treatment of ME/CFS, focusing on case-defining symptoms, such as cognitive impairment and unrefreshing sleep among others.

The method entailed using a proprietary in silico platform—that is, based on an algorithm, not an experimental biology investigation—called Clinical Outcome Search Space (COSS) to predict compounds relevant to ME/CFS Symptoms. COSS analysis is a literature-based modeling approach for making predictions that uses two basic steps. The first step is the creation of multi-dimensional profiles of biological entities of interest such as drugs, disease, genes, proteins and adverse events. The second step is the ranking and prediction process.

Naltrexone is an FDA-approved drug for the use of opioids addiction. As an opioids receptor antagonist, it binds opioids receptors with the net effect of reversing or blocking the opioids effects. Low Dose Naltrexone has been used as an “off-label” treatment for some conditions unrelated to addiction or intoxication, like Multiple Sclerosis and Fibromyalgia. Trazadone is an antianxiety drug with sleep-inducing benefits. It belongs to the serotonin antagonist class of drugs and has been used by many ME/CFS specialists to help in the management of ME/CFS symptoms.

It is important to emphasize that the outcome of this research is the result of computer-assisted methodologies only; these drugs have not been tested by the company through experimental investigations for safety, synergy or efficacy with regard to ME/CFS. Making these two drugs known is in no way an endorsement of their use. No clinical trials have been undertaken, and dosage and ratios are as yet unknown.

That said, many patients have experience with Trazodone and LDN since multiple physicians treating ME/CFS prescribe them. The familiarity of these two drugs could warrant further investigation.


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Personally, I'm underwhelmed. Kind of disappointing.
 
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minkeygirl

But I Look So Good.
Messages
4,678
Location
Left Coast
You'd think they'd focus on some really significant meds that have had success for off label use. Like arv's for example.

I've used trazodone on and off for the over 20 yrs. I've been sick. I'm not cured. LDN also not cured but helps a minimal amount.

Next they'll tell us Nurofen is being studied to treat us.
 

Kati

Patient in training
Messages
5,497
You'd think they'd focus on some really significant meds that have had success for off label use. Like arv's for example.

I've used trazodone on and off for the over 20 yrs. I've been sick. I'm not cured. LDN also not cured but helps a minimal amount.

Next they'll tell us Nurofen is being studied to treat us.
Imagine if one drug for ME/CFS gets approved. Say Trazodone, an anxiolytic and sleeping pill, gets approved as the only FDA-approved treatment for MECFs. What does it tell the physcians from across all countries? That we need psych meds and nothing more.

Compare that to Rituximab, Ampligen and Valcyte/Valtrex, all of which works on modulating the immune system.
If these drugs actually passed phase 3 trials, we would have pharma engaged, physicians would pay more attention and NIH funding biomedical research.

Personally I have tried Trazodone on 2 different attempts to help me sleep and the drug REALLY didn't agree with me ( and I am not sensitive to meds)
 
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nandixon

Senior Member
Messages
1,092
I get the impression that it's the combination of the two drugs together that they think is interesting. My understanding is that Biovista was supposed to apply for patent protection for this combination. (They wouldn't be able to obtain patents on the drugs individually as is.)

How well that combination might work for most of us is another matter. LDN individually was bad for me. Trazodone on the other hand helped with my sleep (both onset and quality) at a low dose of 12.5mg (1/4 tablet). But after a couple years I found that it had insidiously begun to significantly decrease my already very poor energy levels and I had to stop using it. Some research revealed that it has the capability to cause mitochondrial impairment, which apparently may occur in susceptible people.
 

alkt

Senior Member
Messages
339
Location
uk
You'd think they'd focus on some really significant meds that have had success for off label use. Like arv's for example.

I've used trazodone on and off for the over 20 yrs. I've been sick. I'm not cured. LDN also not cured but helps a minimal amount.

Next they'll tell us Nurofen is being studied to treat us.
the drug companies prefer drugs that mask symptoms simply because their is far more profit and profit is the main motivator for pretty much everything . and i wish i could still take ibuprofen unfortunately it stopped working for me immediately after the beijing flu caused my m e .
 

snowathlete

Senior Member
Messages
5,374
Location
UK
Very underwhelming. I was expecting a list of twenty drugs that could be explored for potentially large dramatic effects.

I'd be interested to see the underlying data and to understand what computer-assisted methodologies were employed. It looks like these were just plucked out of thin air on the basis that they are known to aid some patients already (quite a coincidence otherwise) and because they are cheap, generally safe, management drugs.

I hope this didn't cost lots of money to do. Id rather the NIH invested in treatments we can't access already that might help to a larger degree.
 

jimells

Senior Member
Messages
2,009
Location
northern Maine
I'd be interested to see the underlying data and to understand what computer-assisted methodologies were employed.

No one will ever see the top-secret, proprietary magic software that spit out "LDN" and "Trazadone" as "The Answer". Besides, it's too complicated for mere mortals to understand, except for Computer Priests, who have been specially blessed by the Computer Gods.

Before becoming a full-time sick person, I used to write computer software. Thirty years ago I worked for a small outfit that wrote and installed software for wholesale distributors. One of the key selling points was a Magic Formula that could predict when stock should be re-ordered, It look impressive, and the formula even included a square root sign.

One day I decided to put the Magic Formula to the test with actual data, and carefully examined the results: it was completely bogus. And I told only my close associates - none of the clients actually used the report with the Magic Formula anyway, so why upset the apple cart?


It looks like these were just plucked out of thin air

Yup.
 

Snow Leopard

Hibernating
Messages
5,902
Location
South Australia
Finally, an update on this!

I'm not that impressed with these drugs... A strong antidepressant (serotonin antagonist and reuptake inhibitor) and a opioid-receptor antagonist?

But would be glad to see a decent clinical trial of LDN which should hopefully eliminate some of the hype. They'd better have separate LDN and Trazodone arms, because comparing the combination just to placebo is poor study design.

There is a potential for bad adverse effects from such a trial though.

Trazodone is know to cause severe drowsiness in some as a side effect. I guess it is for those with sleep rhythm issues.
 
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jimells

Senior Member
Messages
2,009
Location
northern Maine
Two-and-a-half years after announcing that there has been a "discovery" (while keeping the discovery secret), they have yet to organize a clinical trial? I guess they are not really in much of a hurry after all...

Why are they announcing this now? Is this just a part of their annual fund-raising campaign?
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Unfortunately, I never expected much from this process because, if I remember correctly, they were purely looking at symptoms rather than measurable biomedical abnormalities (e.g. cytokine differences or NK cell dysfunction.) So I guessed that they were only ever going to come up with pharmaceuticals that had an impact on sleep and pain etc. I wouldn't strongly object to a clinical trial for LDN, but I've never seen anyone report that it has more than a minimal benefit. Nancy Klimas wants to test a drug that has an impact on the function of a specific cytokine (i can't remember the exact details), and I'd rather see any available funds get directed towards that.
 

mfairma

Senior Member
Messages
205
This finding is obviously laughable.

The decision to undertake this work was clearly done in the past, and CAA has changed so much. Hopefully that includes axing enough of their board to ensure that this kind of result does not happen in the future.

It seems a bit of a strategic misstep for an organization even to admit it paid money for this.