Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

Discussion in 'Research News' started by attheedgeofscience, Sep 19, 2014.

    1. Viking
      No Mood

      Viking Member Benefactor

      Location:
      Italia
      f I'm not mistaken, the second phase of the study began in October, and if the duration of the trial requires a maximum of 4 weeks with this new molecule, we suffer from tinnitus could hope for a solution in a very short period compared to the expected (2018- 2019). I hope not to be wrong
       
      • Optimistic Optimistic x 1
    2. SteveToHeal
      Insomnious

      SteveToHeal Member

      Location:
      Unknown
      Tinnitus Since:
      10/2013
      Cause of Tinnitus:
      Acoustic trauma
      Its not that clear guys but let her comment. Only she can say or not if it went away or not and came back only 17 months ago or not. That is all i was saying. So no point carrying on with this discussion until she confirms. Tx.
       
    3. CathodeRaySound

      CathodeRaySound Member Benefactor

      Location:
      Boulder, CO
      Tinnitus Since:
      08/2014
      To be honest that doesn't seem to say much. She might be asking what if she has had tinnitus for 11 years but it comes and goes, would that be grounds to exclude her? Let's not make assumptions based on interpretation, perhaps she should make herself more clear. For all we know it might be a legitimate question or concern of hers.
       
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    4. SteveToHeal
      Insomnious

      SteveToHeal Member

      Location:
      Unknown
      Tinnitus Since:
      10/2013
      Cause of Tinnitus:
      Acoustic trauma
      Agreed. Before jumping all over her and making accusations what she meant and that she is purposefully trying to skew the results... let's get the full picture. Nobody here is out to lie and skew the results. That is obvious. We are all in this together. Tx.
       
      • Agree Agree x 1
    5. 111

      111 Member

      The grammer of the sentance is quite easy to understand when written in the above manner, look at what she says, what do you think she says BUT for, followed by the word IF in the bottom sentance, the below is the sentance split up to make it easier to undersand

      so i have had t for 11 years
      BUT
      what if i got t 11 years ago and then it went.
       
    6. SteveToHeal
      Insomnious

      SteveToHeal Member

      Location:
      Unknown
      Tinnitus Since:
      10/2013
      Cause of Tinnitus:
      Acoustic trauma
      Still not clear --> It can be interpreted like this: "so i have had t for 11 years. <what if i taken out> I got t 11 years ago and then it went." The "what if i" could be interpreted as either "this did happen" or "this didn't happen". It's a question. It's not saying she did or she didn't.

      Can I make a suggestion tho that we leave this for now and get it from the horses mouth rather so as not to clutter this thread with "who said, she said"?

      I'm leaving this interpretive debate on what she meant now.

      Thanks
       
    7. CathodeRaySound

      CathodeRaySound Member Benefactor

      Location:
      Boulder, CO
      Tinnitus Since:
      08/2014
      Because it is a big BUT. She has had tinnitus for 11 years, BUT what if it it also comes and goes, would it include or exclude her? For someone so concerned with grammar and semantics, your spelling doesn't do you any justice...just saying, if you want to get on that level...you can think what you want, it's still up to her to clarify what she meant.
       
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    8. Rhea
      Volatile

      Rhea Member

      Location:
      UK
      Tinnitus Since:
      2004
      wow ..... anyone ever heard of manners here?.....all this "she" business , I do have a name!

      Anyway, "she" who is me, was half joking when I made my previous post....I have had t 11 years solid..it hasn't gone and come back in the last 17 months...I was simply saying do you think I could get in on the trial if I told them that.

      I appreciate people saying that nobody she lie to get in on the trial, I get that completely. Although wow, have some compassion people, 11 years with intrusive t has taken it's toll on me and I am on the edge and running out of will to carry on, i'm desperate in fact...so please don't ask "why" would someone try and get in on the trial if they don't met the criteria...I think anyone with intrusive t would completely understand the "why".

      Enough said, let's just hope some people here on the forum that meet the criteria get in on the trial so they can tell us how it goes rather than us all having to wait another year or so for Aut' to release the results.
       
      • Agree Agree x 4
      • Optimistic Optimistic x 1
    9. Rhea
      Volatile

      Rhea Member

      Location:
      UK
      Tinnitus Since:
      2004
      Also...damn it is so unfair they only want people up to 18 months...surely us long timers who have been dealing with this for years and years are more in need of some relief than people who have only had to put up with it for a year (no disrespect to the newbs, I know many are suffering badly as well but I just mean in terms of the time having to endure this us long timers may be more worn down and running out of strength to fight it etc)

      Why only 18 months max do you think?....really hacks me off that
       
      • Agree Agree x 1
    10. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      I think benryu tried to explain this earlier in the thread. I can't really remember but I think it's because the drug works faster if the T is more recent, and that more chronic cases would take much more time (but probably still work). Maybe it's just easier for them to conduct it this way if that's the case. Maybe that's why the trial time only is 4 weeks. I think they are holding in on so much info so we can only speculate.

      And as a fellow old timer I agree with you. We should be the first in line :)
       
    11. 111

      111 Member

      Thanks for clearing this up, your original sentance explained this anyway.
       
    12. 111

      111 Member

      check your own before you comment.
       
    13. Rube
      Fine

      Rube Member Benefactor

      Location:
      USA
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Loud shit
      if the trial is due to start in October then I guess we should see the trial patient request forms pop up any day now?
       
      • Agree Agree x 1
    14. CathodeRaySound

      CathodeRaySound Member Benefactor

      Location:
      Boulder, CO
      Tinnitus Since:
      08/2014
      @111

      I still stand behind my point, not only for this instance but for future instances too. I will always wait for clarification before jumping to assumptions, especially if a comment is stated in such a way that it can be interpreted in multiple ways. If Rhea was indeed implying a genuine question, I wouldn't have felt like an ass for making the wrong assumptions, maybe you would have. Safety first. Now back to the topic on point.

      @Rhea

      Thanks for the clarification, I would have felt terrible if I automatically assumed anything about you, then I turned out to be wrong. Although I don't agree with lying to get into a clinical study I can't speak for someone that has been put to the edge as you have over 11 years of tinnitus. I would be lying if I said, "I know for a fact I wouldn't" because I can't even imagine the frustration and desperation you're going through. Only you would know that. Speaking from what I loosely know from reading knowledgeable people on here and doing my own studies, AUT00063 should be promising for chronic tinnitus, be it 1+ year or 10+ years, it might just take longer for you need feel the results from taking the medication, don't lose the will, you've came this far and now you're closer than ever.
       
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    15. SteveToHeal
      Insomnious

      SteveToHeal Member

      Location:
      Unknown
      Tinnitus Since:
      10/2013
      Cause of Tinnitus:
      Acoustic trauma
      Hey Rhea,

      Apologies for the "she" reference. I'm on your side here. It just hacks me off when people dish out judgement after what they think others should do / should not do. I agree with CRS - some are all too quick to jump to conclusions and pass judgement before clarification, regardless of what the interpretation was. I get the whole don't lie, effect the trial thing yet I also have huge compassion for people with long suffering T.

      Each to their own. Whatever you choose, all the best and I hope you find peace soon.

      Steve
       
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    16. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      @Rhea,

      I figured I'd pop in to clear up the air on why most likely Autifony has a narrowed scope for their clinical trial. The window of time that they make available to people who have had tinnitus, greater than six months but less than eighteen speaks volumes IMO. First of all, they want these people to be "chronic", but it seems not "too chronic". As always with drug development, these people are out to get their product approved and make money first and foremost. Helping people is a secondary concern. Autifony wants to be able to say their product can help chronic tinnitus sufferers, but as Thomas Meyer once said in an email to forum members here, the "tinnitus field is littered with failed trials and experiments" because of a failure to adequately define the scope of who may benefit. This is a Phase IIa trial, the first that will offer them a glimpse of efficacy. You can bet they want to make sure they set it up in such a way that efficacy IS shown. If in this trial they notice there is no decrease of efficacy towards the end of their 18 month window, you can bet they'll raise the roof on their window for Phase IIb clinical trials or Phase III clinical trials. This window shows that they have a good inkling that AUT00063 will help people to a good degree, but they're not exactly sure how much and who yet. They're trying to figure out the "who" part of it right now.
       
      • Informative Informative x 6
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    17. Lisa88

      Lisa88 Member

      Tinnitus Since:
      11/2013
      Seems they need to break it down by time frame, with the next phrase expanding time on the previous. Otherwise no controlled comparative studies can be made. Other trials conduct their phases in stages this way also. See 101 etc.
       
    18. Rube
      Fine

      Rube Member Benefactor

      Location:
      USA
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Loud shit
      agreed and im sure they have a plan to do just that......im just praying that they bring the phase 2 trials to usa!! which i cant see why they wouldnt. Big dollars to be made in usa regarding T.
       
      • Like Like x 1
    19. Lisa88

      Lisa88 Member

      Tinnitus Since:
      11/2013
      Just wanted to respectfully add that there is so much aggression and negativity on the latter part of this thread - "it won't work re drug interaction", "it won't work for the elderly", "they are setting it up" ... etc. But with all that I have read re opening potassium channels and t, this is one of the most hopeful treatments so far. Yes, people will react differently to it, as is always the way with t. But please let's try to be cautiously excited at least, and see how it unfolds. Hope is paramount to people with t.
       
      • Optimistic Optimistic x 2
    20. Lisa88

      Lisa88 Member

      Tinnitus Since:
      11/2013
      To let it unfold, rather than shoot it down. As we Brits like to say, "The proof is in the pudding". And in the next few months there will be a lot of pudding :)
       
      • Agree Agree x 3
    21. Eric Fridley

      Eric Fridley Member

      Location:
      Tucson AZ
      Tinnitus Since:
      06/2014
      so autifony phase 2 is starting in october am i right and there testing this on people with tinnitus will this help people with uknown cause of there tinnitus cause i seen on there website it works with people that have hearing loss acoustic trauma and aging
       
    22. Rube
      Fine

      Rube Member Benefactor

      Location:
      USA
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Loud shit
      i just read this on autifonys site. apologies if posted already

      "Autifony’s lead compound, AUT00063, has successfully completed Phase I clinical trials, and Phase IIa studies are being planned for age-related hearing loss in the US, and for tinnitus in the UK. This latter with funding support from the UK’s Technology Strategy Board. Both trials are due to start later in 2014."

      maybe we will see tinnitus trials in usa sooner rather than later!
       
    23. rtwombly
      Bookworm

      rtwombly Member

      Location:
      Southeast USA
      Tinnitus Since:
      01/2014
      Cause of Tinnitus:
      Unknown
      Sorry to burst your bubble. That's been on there since well before Dr Large mentioned by email that there are no current plans for a US trial. Seems like that was the plan early on, but logistics got in the way. Still, if the trial goes really well in the UK, maybe it'll mean a new influx of cash from the PTB and those US trials will get rolling.
       
    24. Rube
      Fine

      Rube Member Benefactor

      Location:
      USA
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Loud shit
      well that stinks. but i have hope it will roll out here as well. am101 did so i cant see why autifony wouldnt.
       
    25. Grace
      No Mood

      Grace Member

      Tinnitus Since:
      11/14/2013
      I live in the usa and could careless if they have trials here.. All that should matter if the drug turns out to work. If it does everyone can bet there ass that it will make it to the usa for further trials patience is all it is. I know everyone wants to participate in them but we do have members from the uk on here.. If they get on and theres success then we can all be happy where ever the hell we live cause it will make it to us eventually! :)
       
      • Agree Agree x 3
    26. Rube
      Fine

      Rube Member Benefactor

      Location:
      USA
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Loud shit
      Good point
       
    27. 111

      111 Member

      I knew i was right after reading the post once, unlike yourself of course, so no wrong assumption from me.
       
    28. valeri

      valeri Member Benefactor Hall of Fame

      Location:
      Australia
      Tinnitus Since:
      09/2011
      Would somebody know what happens after 4 weeks of this trial?
      Do they publish results or more trials is needed before we know a u results?
      I'm afraid that this may take years even if proven successful:(

      This is all happening really sloooooow.......
       
    29. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      Dear Valeri,
      After 4 weeks they will collate all the data and wait for all the other sites to be finished (they probably not all take place simultaneously). After that, they will crunch the numbers and run them thru statistical analysis programs. They will record all drug side effects. Then they will get together in a secret room and conduct a meeting between the CEO, scientists, business managers, market analysts, big pharma rep, investor reps, etc), where they will discuss the outcome and decide on the next steps.
      After that the public relations officer will make an announcement accordingly.
      If the phase 2 is successful, they will publish the results and announce dates for phase 3.
      I'm thinking this time next year for this announcement.
       
      • Agree Agree x 1
    30. Grace
      No Mood

      Grace Member

      Tinnitus Since:
      11/14/2013
      It isnt gonna take years. They need time to conduct the trials to make sure the drug is doin its job..if they have positive results within those first 4 weeks and its really good news, depending on how they handle it they may wanna keep the results quiet because they know people out there will go nuts and want the drug---- or they will maybe make a statement sayin the drug has positive effects, and we will continue further trials. One way or another someone on here or from somewhere else will hear something might be here say but im sure we will know not long after. We just dont know until we wait or until we hear something
       

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