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Biovista and CAA identify candidate drug for repurposing

Firestormm

Senior Member
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Location
Cornwall England
I'm actually not certain the drugs are currently being used by ME/CFS patients. I don't recall that from any of the communications around the study.

In terms of footing the bill, the Association funded the study that identified these targets. I don't know who is footing the bill for the first trial - maybe Biovista and Association combined?

Morning Jenny, there's an article on the way about Suzanne's talk though I must confess that at this time of the morning, I am confused by my recollection of it - I thought these drugs might have come about through the clinicians' survey i.e. they are known and used by some patients and prescribed by some physicians; but this 'drug repurposing' as Nielk correctly highlights: well, it's thrown my thinking off target :eek: So I don't know what they could possibly be investigating. However, even a 'trawl of the literature' would be CFS literature so I guess the drugs will be recognised by the community. Bums. We'll all have to wait, though for how long I couldn't say...
 

urbantravels

disjecta membra
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Los Angeles, CA
Where are the rest of the slides? I can't find a damn thing right now, I haz a dysfunctioning head.

If the two drugs in the proposed combination therapy *are* both drugs that are currently used by ME/CFS patients, then odds are that some people out there are already taking both. What's not clear to me is how the "combination therapy" becomes something that you couldn't just reproduce by taking the existing drugs together.

I have some nutty ideas in my head based on the above slide and what I just read concerning the Central Fatigue Hypothesis....but it's too complex a situation with the serotonin and the norepinephrine and the dopamine and all for me to start guessing at drugs.
 

urbantravels

disjecta membra
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Los Angeles, CA
Firestormm slipped in while I was posting.

I think the "trawl of the literature" may be broader than you suggest. They may be looking at individual symptoms or known dysfunctions in ME/CFS and then looking though ALL the literature on those problems, across multiple conditions. Like for instance...maybe they could punch in the specifics of the types of sleep dysfunction seen in ME/CFS, see if some similar sleep problems occur in other conditions, or primarily, and then see everything that's been tried for those specific problems. So then you might get some drug suggestions that would also target some other ME/CFS symptom or dysfunction. It wouldn't have to come from the ME/CFS literate, thin and scattered as it is.
 

urbantravels

disjecta membra
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Location
Los Angeles, CA
The FitBit which Dr. Munos talked about is actually a great tool to amass information. When I took part in the Mt. Sinai study a couple of months ago, I had to wear one the entire 4 days of the study. It tracks all activity like steps, distance, stairs climbed as well as sleep cycles. It then syncs all this information wirelessly to the FitBit website so that one can see real time progress.


Neilk, what was that Mt Sinai study? Can you point me to anything "official" about it online?
 

Nielk

Senior Member
Messages
6,970
This is from the Biovista website:http://biovista.com/biovista-and-th...repositioning-milestone-with-pre-ind-meeting/

Charlottesville, VA and Charlotte, NC, May 29, 2013 /PRNewswire/-

Biovista and the CFIDS Association of America announced today the successful completion of the first phase of their collaboration. Funded as part of the CFIDS’ Research Institute Without Walls, Biovista identified candidate treatments for CFS using its state-of-the-art COSS approach. Two candidate treatments, including a combination therapy were identified and are being prepared for proof-of-concept clinical trials, with an FDA pre-IND meeting scheduled in Q3 2013.
 

user9876

Senior Member
Messages
4,556
Its not about patents, mostly. Its about where biovista is being funded from. It is likely though that the patent holder will be doing some funding, or collaboration, or something. Also there is a new tendency to reformulate and repackage an old drug, give it a new name, and file a new patent.

If they are trawling throught the literature for things that have been tried then they won't be able to get a patent (unless the publication was within the previous year) in which case those publishing the paper would be able to apply in the US for a patent (athough not in europe). Basically to patent an idea it has to be novel but if it has been published it clearly isn't. However in the US you get a years grace in which to file an application.

If they can't patent then they may want to keep the drugs they are testing secret until they work out a way of generating a revenue stream from what they are doing. Hence there might be quite a delay.

If they are trawling through the literature and then applying different techniques then they could patent. For example, they might look at immune system papers and try other immune system modification techniques. I'm assuming that they could then patent this. New patents are quite cheap, I believe they get more expensive over time so that only the most valuable patents get kept. Drafting a patent can take a little while since you are expected to cite the relevant prior art. You may even find that they want to do some initial experimentation in order to make some more specific defendable claims.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
No user9876, a patent is a unique invention. Sufficient change to an invention is enough to qualify for a new patent. Its already been done, though I am struggling to recall the name of the drug (its an antidepressent, used to be called prozac I think). Its now a new wonder drug, but its the same old prozac, just a different formulation. So the idea can be old, but if there is enough modification then its still a new invention. If they own the old patent, and its still in force, then there is no conflict either.

You can bet that injectable rituximab is likely to have a new patent too.
 

Firestormm

Senior Member
Messages
5,055
Location
Cornwall England
This is from the Biovista website:http://biovista.com/biovista-and-th...repositioning-milestone-with-pre-ind-meeting/

Charlottesville, VA and Charlotte, NC, May 29, 2013 /PRNewswire/-

Thanks Nielk. Interesting stuff from Biovista. I read that to mean a combination therapy AND an individual drug. So a couple of drugs in combination - and an individual drug; all of whom are known about although not necessarily (because we don't know yet) used in the treatment of CFS symptoms. So next announcements will be made in Q3 at which time we'll know what they're working on probably. Hmmm...
 

urbantravels

disjecta membra
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1,333
Location
Los Angeles, CA
Thanks NeilK - I was looking for something like the official clinical trial announcement or something similar that would describe the study and the basic protocol. I need evidence that actometers have been used in legitimate scientific research studies to demonstrate activity levels. Was it on clinicaltrials.gov?
 

Nielk

Senior Member
Messages
6,970
Thanks NeilK - I was looking for something like the official clinical trial announcement or something similar that would describe the study and the basic protocol. I need evidence that actometers have been used in legitimate scientific research studies to demonstrate activity levels. Was it on clinicaltrials.gov?


As far as I know this is not a government funded study. It is privately funded. You can try calling Dr. Enlander or e-mail Micol Zweig at : micol.zweig@mssm.edu
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
Here is something else to consider too. Lots of drugs are on the books at drug companies that never make it to market because they were not effective enough. If biovista is looking at those to see if they work better for ME, then they can be repurposed.
 

Sing

Senior Member
Messages
1,782
Location
New England
Slide71.jpg


This is from the FDA webcast of Dr. Vernon speaking about the two drugs that are being repurposed.

So it looks as though they have focussed on drugs which affect neurotransmitters, specifically neuroleptics. Would this be like Gabapentin/Neurontin? (Is a neuroleptic an anti-epileptic?) This type of drug can help with sleep and pain. Going on to further brain drugs, a medication such as Aricept does help with cognition, as it prolongs the breakdown of acetylcholine. It's the drug of choice for Mild Dementia. Then I wonder if patients would be taking the two medications in one pill or in two? If two, maybe one is an upper or brain activator of some kind, and the other a downer for later in the day. Just guessing!
 

urbantravels

disjecta membra
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1,333
Location
Los Angeles, CA
This is in response to Alex's post, Sing's post slipped in

That's an interesting possibility. I presume the pharma companies go ahead and patent all those drugs even if they're not on the market. If the drug does turn out to be useful for something after all they'd want their IP protected.

After all Viagra was originally developed as a drug for high blood pressure; it was a flop at controlling blood pressure, but the clinical trial participants noticed a certain side effect... and then Viagra wasn't a flop any more. SEE WHAT I DID THERE
 

Sing

Senior Member
Messages
1,782
Location
New England
Oh no, a neuroleptic is an anti-psychotic drug! But, maybe they wouldn't dare go so far as that but stick to the level of a mild tranquilizer of some kind? I am sorry if my guesses are too wild. Maybe I need a neuroleptic.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
This is about symptomatic treatment. It probably will not directly lead to a cure. However if it works it may help us identify mechanisms, and the more we understand about mechanisms the closer we get to a cure.

Neuroleptics modify the brain. Just as they can be considered psychiatric drugs, so they can also be considered neurological drugs. We need to emphasize that if these drugs get marketed.