AFL Using Players on Phase 2 Clinical Trial of New Drugs | BigFooty

AFL Using Players on Phase 2 Clinical Trial of New Drugs

Discussion in 'ASADA, WADA, and Drugs in Sport' started by Catoggio76, Apr 9, 2018.

  1. Catoggio76

    Catoggio76 Team Captain

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    Geez, talk about a cone of silence! Speak up you lot.

    https://smallcaps.com.au/afl-teams-paradigm-biopharma-pain-relieving-medication/
    AFL teams queue up for Paradigm Biopharma’s pain relieving medication
    By
    George Tchetvertakov
    -
    April 4, 2018

    Several doctors from Australian Football League (AFL) clubs are taking advantage of Paradigm Biopharma’s (ASX: PAR) existing drug for the treatment for knee, hip and groin pain which has not responded to current therapies.
    The drug is made available under the Therapeutics Goods Administration’s (TGA) Special Access Scheme (SAS).

    According to Paradigm’s CEO Paul Rennie, seven AFL clubs have taken advantage of the new treatment, currently being used by 40-50 former and current AFL players with reportedly outstanding results.
    One of the clubs confirmed to be using the treatment is Carlton Football Club, with at least three more Melbourne-based teams also cited as being participants.

    Given the associated public interest, especially from footy fans that idolise the players playing for their teams, the AFL clubs involved in the use of the medication have been coy to provide exact details regarding which players have been treated by Paradigm’s patented drug candidate Pentosan Polysulfate Sodium (PPS).

    ...

    In its current phase 2 trial, patients are administered with two injections of PPS per week for six weeks for a total of 12 injections.

    ....

    With several AFL clubs confirmed to be using PPS, and with such great success being reported by patients, it may only be a matter of time until Paradigm’s PPS drug is being used by other AFL clubs and other high-performance sports in Australia and overseas.

    Paradigm shares were up 7% and trading around $0.30 per share in light trade.
     
    Last edited: Apr 9, 2018

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  2. RussellEbertHandball

    RussellEbertHandball Premium Platinum

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    Who is this author to say it is in " current phase 2 trial." It might be trialed for a new use to its original 1948 intention, but this is not a phase 2 trial of a new drug.

    CEO Paul Rennie was on Sportsday SA last week and clearly spelt it out what the history of this drug to prevent blood clotting, going back to its registration in Germany in 1948. You can hear the interview below between 4.45 and 13.35. Journo's struggle with technical info and someone at the AFL getting into a tizzy PR spin when they hear the word drug.

    At about 11.55 Blight asks Rennie is this a clinical drug trial? Rennie says straight out -this is not a trial! Its a drup approved in 4 of the 7 major pharmaceutical markets. He also said its not a trial at around 5.55.

    https://omny.fm/shows/sportsday-sa/fiveaa-april-5

    A lot meh about this issue if you understand the WADA Code and the relevant TGA approval procedures.
     
  3. jenny61_99

    jenny61_99 Premium Platinum

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    It could certainly be undergoing clinical testing because it is being used for something other than it's original intent. So they will have made a proposal to test the efficacy of the compound at specific dosage levels, for its anti-inflammatory properties within joints and ligaments. (Note: they do this so they can market it using those claims). Phase II is very early days within the process.
     
  4. RussellEbertHandball

    RussellEbertHandball Premium Platinum

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    So why did the CEO say its not a clinical trial when speaking to Sportsday SA?
     
  5. jenny61_99

    jenny61_99 Premium Platinum

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    Why do you think?
     
  6. RussellEbertHandball

    RussellEbertHandball Premium Platinum

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    Isn't it more like a study. Isn't a trial first to prove its safe which they did in 1948? Or is safety defined as a stage 1 trial.
     
  7. jenny61_99

    jenny61_99 Premium Platinum

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    Obviously clinical trials have changed over the years... certainly since 1948! Sure it could be a study.... but they shouldn't be plugging into the boys until they know for sure re efficacy and contraindications IMO.
     
  8. RussellEbertHandball

    RussellEbertHandball Premium Platinum

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    I know you work in the area, so walk me through what has happened with thalidomide. First it was approved for sedative, then for nausea for pregnant women, then they discovered it caused birth defects and wasn't banned outright but was banned to be prescribed to pregnant women and last 10-20 years its been used to treat leprosy and cancers and even a few other conditions.

    How many times does it have to go thru a full blown phases of clinical trials?? Every time someone wanted to use it for some treatment other than its original use?
     
  9. Catoggio76

    Catoggio76 Team Captain

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    Eerily similar line as to how AOD9604 found its way into the AFL system.... hmmmm....
     
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  10. yaco55

    yaco55 Premium Gold

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    The thrust of Warner's articles is looking at the AFL's new Drug Code and administration ( which in some cases is tougher than the WADA Code ), the mechanics of its operations and it's overall effectiveness - Its has nothing to do with the WADA Code.
     
  11. jenny61_99

    jenny61_99 Premium Platinum

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    These days by the time drugs get to clinical trials, a lot is already known about them (in terms of potential side effects and how it will likely behave dealing with a specific disease). But they will generally have only tested in relation to the target disease. While you can probably correlate these results to other treatments (in terms of dosage tolerance), you can't be sure, and I believe because of things like thalidomide, you'll have big pharma erring on the side of caution. It's a bit like AOD9604 - that had been developed as an anti-obesity drug where they found in early trials that it actually had positive properties in tissue repair (and not so much for the anti obesity). In an attempt to protect the millions already spent on getting the drug to this stage, they decided to change directions and were trialling it with athletes. It also comes down to marketing. If you want to sell a drug making claims about specific diseases, then you have to have the research to back it up.
     
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  12. HairyO

    HairyO Brownlow Medallist

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    Time for WADA to come in over the top.
     
  13. RussellEbertHandball

    RussellEbertHandball Premium Platinum

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    Why? Its not performance enhancing under any category and doesn't fall into S.0 category of WADA Code that is a catch all clause for new drugs that haven't received government approval for human use anywhere in the world. This drug was patented in 1948 and is sold in several countries in Europe - supposedly 4 of the 7 largest pharmaceutical markets in the world according to Paul Rennie CEO of the company using it in Oz.

    This is a performance enabling drug just like painkillers, narcotic analgesic or opioid medications, corticosteroids etc that require a Theraputic Use Exemption. Ok put it on some watch list to study it, but maybe that has been done because its been used for more than its original use of stopping blood clots in its home market of Germany and other markets its marketed in.
     
  14. Muggs

    Muggs Premiership Player

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    Personally think it's different to AOD9604.

    This drug is not on the list of banned substances and it can be checked. Due to its other uses it is approved for human use as such not covered by SO. The issue around AOD9064 was its legality in the first place.

    What is happening now are athletes looking at using something for use other than what was initially designed for, sure it's in the AFL, but do you really think athletes around the world don't look for things like this. Just look at how many TUEs there are.
     
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