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Biovista and CAA identify candidate drug for repurposing

Discussion in 'General ME/CFS News' started by Sasha, Jun 2, 2013.

  1. Sasha

    Sasha Fine, thank you

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    Has this already been posted and I've not seen it?

    http://www.drugs.com/clinical_trial...ca-reach-milestone-pre-ind-meeting-15606.html

    Biovista and CFIDS Association of America Reach Milestone with Pre-IND Meeting

    CHARLOTTESVILLE, Virginia and CHARLOTTE, North Carolina, 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.

    "We are very excited to have reached this stage within a year of
    starting our collaboration. We look forward to furthering our
    understanding of this complex disease and developing a treatment that
    will improve CFS patients' quality of life," said Dr. Andreas
    Persidis, Biovista's CEO. "Our work is an example of things to come in
    terms of novel collaboration models that promise to accelerate
    treatment development and, through the drug repositioning approach, do
    so cost effectively," Dr Persidis added.

    "There is a big gap in the pipeline that moves basic laboratory
    research into safe and effective treatments. Without a bridge to bring
    discoveries to the clinic, laboratory research rarely becomes more
    than a paper. We are providing the means for basic researchers to move
    discoveries through the translational research pipeline with our
    Research Institute Without Walls," said Kim McCleary, president and
    CEO of CFIDS.

    "Therapies for ME/CFS are an unmet medical need. This is largely due
    to the lack of translating the scientific knowledge into meaningful
    impact for patients," added Dr. Suzanne D. Vernon, Scientific Director
    of CFIDS. "We understand the ME/CFS knowledgebase and know how to fill
    this gap. Biovista recognized the opportunity for discovery. This drug
    repositioning project is an excellent example of effective use of
    existing information to make a new treatment discovery."

    About Biovista

    Biovista finds novel uses for existing drugs and profiles their side
    effects using mechanism of action analysis. Biovista develops its own
    pipeline in CNS, oncology, auto-immune and rare diseases and
    collaborates with biopharmaceutical companies and Patient Groups on
    indication expansion, portfolio de-risking, and adverse event
    prediction. (http://www.biovista.com).

    About CFIDS

    The CFIDS Association of America is at the leading edge of ME/CFS
    research. For more information, please visit The Association's web
    site at http://www.cfids.org or their research blog at
    http://www.Research1st.org

    Contacts
    Biovista
    Dr. Andreas Persidis
    andreasp@biovista.com
    T: +1-434-242-6514

    The CFIDS Association of America
    Dr. Suzanne D. Vernon
    sdvernon@cfids.org

    Posted: May 2013
     
    Valentijn likes this.
  2. Sasha

    Sasha Fine, thank you

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    snowathlete likes this.
  3. Desdinova

    Desdinova Senior Member

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    LOL why even tell us about it if they can't give details?
     
    justinreilly likes this.
  4. Sasha

    Sasha Fine, thank you

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    I suppose it's good to know the process is progressing, but, argh...
     
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  5. Nielk

    Nielk

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    They spoke about this at the FDA meeting last month without mention of what the name of the drug is.
     
  6. Firestormm

    Firestormm Guest

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    I was very displeased when listening to the video of that conference that the names of the two drugs were withheld. I am very surprised this wasn't raised by those in the audience.

    What's the big secret? Hopefully we aren't talking antidepressants!
     
    ggingues likes this.
  7. Sasha

    Sasha Fine, thank you

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    It seems to be some sort of regulatory or contractual thing, but I'd like to know the reasoning behind it. I agree it's frustrating.

    I remember reading that in the early days of AIDS clinical trials, which were double-blind and placebo controlled, patients were so desperate for the active drug that they cut their doses in half and swapped a half with another patient so that they'd both have some chance at least of getting the active drug. I'm starting to feel like that.
     
  8. Navid

    Navid Senior Member

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    I remember reading that in the early days of AIDS clinical trials, which were double-blind and placebo controlled, patients were so desperate for the active drug that they cut their doses in half and swapped a half with another patient so that they'd both have some chance at least of getting the active drug.


    this brings tears to my eyes......1) that ppl who are dying still maintain compassion and decency to help their fellow human 2) that the medical/science world is so f'd up that ppl have to go to these extremes in order to bypass the bureacracy that is literally killing us (them-the AIDS pts)


    how much longer do we have to wait for some treatments that may actually help us while not costing us an arm and a leg just to take a chance that something may give us our lives back (ampligen, ritux, seeing cheney, gc-maf.....etc). yes hope is nice but we need concrete help...NOW!!!!
     
    shannah likes this.
  9. alex3619

    alex3619 Senior Member

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    The secrecy is standard commercial caution. If you tell someone about something, then you can publish first and maybe win a contract. I don't know how these things work exactly, but its not a surprise. However its likely that the patent is owned by a major company, so there will be negotiating behind the scenes.
     
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  10. Desdinova

    Desdinova Senior Member

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    I sincerely hope that it's nothing along the lines of antidepressants. I shudder at the thought of how the ME/CFS community at large would react. It would IMO be a bad PR move on the part of the CFIDS Association of America.
     
  11. Valentijn

    Valentijn Activity Level: 3

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    :(

    ... You can have half of my sublingual B12 :hug:
     
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  12. Firestormm

    Firestormm Guest

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    Hi Alex,

    From what I understand about how these two drugs were arrived at - by trawling the data of published studies, and from the clinician survey etc. - these drugs are not new. Therefore I can't quite understand the need for secrecy due to patent/s. Will try and ask CFIDS about this later.
     
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  13. taniaaust1

    taniaaust1 Senior Member

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    Im almost ready to bet they will be antidepressants.. that's probably what they are going to come up with seeing (as far as I know) a Canadian consensus defination wasnt being used (let me know someone if Im wrong with that). While crappy CFS definations which are mostly just "fatigue" patients are used, things for the rest of us can never move forward.

    Maybe for once I'll end up being surprised, but I doubt it.
     
  14. alex3619

    alex3619 Senior Member

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    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.
     
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  15. Firestormm

    Firestormm Guest

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    My understanding from the talk (an article of which will be published shortly) that this is a combination therapy. I understand from that to mean - two drugs used together to combat a couple of (unidentified - again, why?) CFS symptoms. So where's the issue? These are drugs that are known. They are approved already.

    I don't understand what a 'proof-of-concept' clinical trial is other than that it will seek to do in practice what BioVista and it's database has supposedly shown through 'trawling'. It just seemed to undermine Vernon's talk. She spoke a heck of a lot of detail about the 'how' this was achieved and then the climax was, well, let's just say that even I have had better :)
     
  16. alex3619

    alex3619 Senior Member

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    I do understand why secrecy is an issue to many of us. Transparency is far better in many respects. In time we may know the answers. In any case it might turn out to be as simple as wanting to publish and therefore not reveal results ... but that only applies if they want to publish the theoretical finding in advance of the testing.

    Personally I would like to see most medical research be completely open ... including raw data. So much of medical research is wrong, the place to start is to put as much as possible in the public domain, and use open publishing. You can't fix a problem you can't see, so to prevent or fix problems you need to be able to see as much as possible. I hate secrecy.
     
  17. Firestormm

    Firestormm Guest

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    It is then ironic that in the speech prior to Vernon's, Munos was exhorting the medical and scientific communities to be open in terms of sharing data...

    Just seems very 'odd' to me that CFIDS would do all the build-up in the talk and then skip over naming the two drugs. Very strange and the announcement of this trial came across as a damp-squib as a result.

    Maybe you are right and CFIDS wanted to write an article that dealt with it specifically - in conjunction with BioVista. And were holding back before the article was published. I'll try and see what gives. Others may well have discovered more about the identity of these two 'magic mushrooms' :)
     
    alex3619 likes this.
  18. SOC

    SOC Moderator and Senior Member

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    My guess is that this is strictly a commercial issue. Read a bit at Biovista's website to pick up some clues.

    Pharmaceutical companies make money when they have something new, most generally patentable. It is likely that the pharma company involved wants to get their product, or combination product, on the market and approved for ME/CFS before their competitors.

    This is reasonable if they paid for the research to find this combination -- they ought to be able to benefit from that investment. Once it's known what the combo is, other pharma companies will jump on the bandwagon using their own similar products -- without having spent the research money. They can charge less because they didn't have the initial investment in research. It's a lousy process, but that's the way it works. If we want pharma to do research, we have to support them making up the cost of research somehow.

    So, I'm guessing Biovista is keeping mum so that their client, the pharma, can have a few months/years jump on their competitors in getting the product(s) to market.
     
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  19. jspotila

    jspotila Senior Member

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    This question was asked over on the Association's Facebook page, and here is what they said in response:

     
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  20. Firestormm

    Firestormm Guest

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    Thanks Jenny :) I still don't understand however. When Vernon made her presentation she was talking about existing drugs being repositioned. I had assumed from this that there was no 'new drug' (IND). Sure the two drugs concerned might go through a 'rebranding' exercise as their original purpose will presumably change (though perhaps not), but their target audience presumably has changed.

    Anyway, their trawling of the existing literature, the databases, and the survey revealed drugs that were seemingly effective at helping to manage one or two symptoms - we could be talking headache and muscle pain or something. So again I can't understand this 'secrecy'.

    It's my understanding at fault here. I'm not suggesting any of this is intentional on their part.

    Thanks again.
     

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