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

[attheedgeofscience]

If I sat in a wheelchair I would still be able to do all those things and ENJOY them.

We have had so many of those discussions on the forum over time (i.e. would you trade one thing for another), and, I can only say: be mindful of those assertions.

 

[Mic]

I wrote the exact the same thought to someone on the forum yesterday (in a PM). Whatever one's position, it is hard to argue that the man is not intelligent.

But science is catching up. And... at-the-edge-of-science wasn't just a randomly picked pseudonym either, haha...

Come on guys... Aut63 could have failed (nothing is certain yet, this will be clear in a couple of days) but this does not mean there will never be a cure...

When there is a problem there is always a solution. The challenge lays in searching for it persistently (do not forget, the human ingenuity is limitless). Maybe therefore we just need to be patient and let the scientists push the boundaries to, not only stay on the edge, but go beyond the edge of science some day.

On a critical note: Lets hope this happens in our lifetime...


​

 

[Nucleo]

I'm hopeful because the trial was a mess...I mean 28 days wasn't a long time, even trobalt took a few months to kick in. Anyway, let's see what happens.

Not to mention the seemingly arbitrary ever-changing inclusion/exclusion criteria

 

[Silvio Sabo]

We have had so many of those discussions on the forum over time (i.e. would you trade one thing for another), and, I can only say: be mindful of those assertions.

I'm not saying I think that people who sit in a wheelchair have it easy. Also it's not the same for everyone. If you are a person who is very active and like going on walks or running marathons loosing ones legs would be a big blow. I'm just saying that for ME it would be a lesser loss then having to live with tinnitus. But we are not equal by any means in our preferences or things we like to do.

I only use my legs to get up from bed to the couch and to walk the 100 yards from my apartment to the bus when I go to work and that's basically it. Rolling around in a wheelchair instead would not be a huge impact. Not like having tinnitus at least. Then there are of course other aspects such as social situations where not being able to walk would be a big drawback. But once again this is me speaking for ME and no one else.

 

[Nucleo]

We have had so many of those discussions on the forum over time (i.e. would you trade one thing for another), and, I can only say: be mindful of those assertions.

This is very true. Never bargain with your condition.

 

[amandine]

Wonder if the real reason is because the hospital, one of the trial centres or more, has messed up and jeopardised the double blind trials.
This fact could cause them to close down really fast....as there would be no value in continuing as the data results would have already been corrupted

 

[Silvio Sabo]

Wonder if the real reason is because the hospital, one of the trial centres or more, has messed up and jeopardised the double blind trials.
This fact could cause them to close down really fast....as there would be no value in continuing as the data results would have already been corrupted

That would at least mean they would most probably redo the study. That's at least something.

 

[Lloyd Carter]

I would take sitting in a wheelchair over this thing any day. I would let them saw off my legs with a hacksaw if I could get rid of this thing forever. But that's me!

Phantom limbs can cause severe chronic pain! Which, like tinnitus, has no relief or cure! The body gets used to pain meds and they no longer have any affect. They even rate this pain on a 1-10 scale and it fluctuates daily (sound familiar?). God bless you and fingers crossed for you to have some quieter days!

 

[Silvio Sabo]

Phantom limbs can cause severe chronic pain! Which, like tinnitus, has no relief or cure! The body gets used to pain meds and they no longer have any affect. They even rate this pain on a 1-10 scale and it fluctuates daily (sound familiar?). God bless you and fingers crossed for you to have some quieter days!

Yeah! There's always that. But then again you don't have to get phantom pain even if it's a possibility. Tinnitus has been compared to phantom pain. I think there is a thread about it on this forum where researchers have stated that tinnitus in fact is phantom pain in the auditory system due to the loss of input. Just like phantom limbs.

The thing is when I think about things like meaning of life I come to the conclusion that it's all about suffering. You just don't know in which way when you're young. I couldn't imagine having this thing 15 years ago. Other people get something else, like cancer or ending up as paraplegics. But we all suffer in some way.

God I wish I could go back to those days. Being young and not knowing...

 

[Bart]

Yeah! There's always that. But then again you don't have to get phantom pain even if it's a possibility. Tinnitus has been compared to phantom pain. I think there is a thread about it on this forum where researchers have stated that tinnitus in fact is phantom pain in the auditory system due to the loss of input. Just like phantom limbs.

The thing is when I think about things like meaning of life I come to the conclusion that it's all about suffering. You just don't in which way when you're young. I couldn't imagine having this thing 15 years ago. Other people get something else, like cancer or ending up as paraplegics. But we all suffer in some way.

God I wish I could go back to those days. Being young and not knowing...

We all wish to go back, but I prefer to go back with the knowledge that I have today or I will just end up with t again !

 

[Philemon]

Not to mention the seemingly arbitrary ever-changing inclusion/exclusion criteria

As well as the fact that, if i remember well, some trialees said on this board that they've not been correctly advised about dosage, like they were taking less than 800mg, or not taking it in one single dosage as they were supposed to ... I hope people at Autifony are aware of those possible irregularities in the trial and will take it into consideration before taking décisions for the future (by the way that was my question for the QA they never answered to)

 

[RCP1]

I am amazed at this development. The Database was meant to close in December and then the analysis done.. So they went in and had a look at the data while the trial was still ongoing - This would actually invalidate their trial - So I am skeptical this is the case.Surely they have just closed the Database and are staring the analysis..

 

[attheedgeofscience]

I am amazed at this development. The Database was meant to close in December and then the analysis done.. So they went in and had a look at the data while the trial was still ongoing - This would actually invalidate their trial - So I am skeptical this is the case.Surely they have just closed the Database and are staring the analysis..

Your line of thought reflects mine, but, the facts as I have found them out today, reflect something else.

 

[valeri]

They should just give the formula to Chinese and the problem will be solved.

 

[Silvio Sabo]

We all wish to go back, but I prefer to go back with the knowledge that I have today or I will just end up with t again !

I'm not sure that would do it for me. I would just end up being afraid of getting it again. Just as I am scared of it worsening now. That fear is maybe the worst part. Worse than tinnitus it self. I want to go back not knowing how this feels. I want this condition not to even exist. It's just insane that there even is such a condition as tinnitus! You go out partying one night or light up a fire cracker and stand too close to it and BAM...f''''' for life!! It's ridiculous.

I really need that cure. And not just for me. What about my kids? I don't have any yet but I imagine I will someday. If there is no cure for this thing I'm going to live in constant fear of them ending up like me. My dad has this thing too. What if it's something that my lineage is prone to? There is no one but me and my dad that have had it in the family that I know of but then again partying and listening to music with earbuds/headphones wasn't a thing 100 years ago.

I really, really need that cure! That's the bottom line.

 

[swc5150]

Your line of thought reflects mine, but, the facts as I have found them out today, reflect something else.

I don't mean any disrespect, but if you have facts directly from Autifony, just share them already please. Enough of this "I know a secret that I can't tell you" stuff. I'm sure Autifony doesn't want any info released before they're ready, which makes me wonder why would they tell you? Sorry I sound like a ****, but this is frustrating.

 

[bellringer]

This would actually invalidate their trial - So I am skeptical this is the case.Surely they have just closed the Database and are staring the analysis..

Auris did the same thing with AM-101. Last month the CEO gave a presentation on the status of the trial and he indicated in the Spring they made a preliminary review of the data and determined that the drug shows promise in those past the 3 month mark and are now focusing on the 3-6 month period.

I don't see how looking at the data as it comes in is an issue. I could understand it if the clinicians dealing with the trialees are involved in examining the data, but they are not.

 

[valeri]

partying and listening to music with earbuds wasn't a thing 100 years ago.

It still isn't unfortunately!
We can thank our reputable associations who haven't lifted a f.....g finger at rising awareness let alone did something for the cure of this hell.

 

[Danny Boy]

It still isn't unfortunately!
We can thank our reputable associations who haven't lifted a f.....g finger at rising awareness let alone did something for the cure of this hell.

Also, how would the centres know if the drug is a dud? It's a double blind test and the centres wouldn't know, as Autifony wouldn't tell them. Sorry, the whole point of a double blind test is to be what it says. The doctors at the centres wouldn't know and whoever sent that email is foolish...Don't they sign NDA's?. I shall await Autifony response and data.

 

[attheedgeofscience]

I don't mean any disrespect, but if you have facts directly from Autifony, just share them already please. Enough of this "I know a secret that I can't tell you" stuff. I'm sure Autifony doesn't want any info released before they're ready, which makes me wonder why would they tell you? Sorry I sound like a ****, but this is frustrating.

I have - as I have done my times before - on behalf of the TT forum contacted two senior representatives of Autifony Therapeutics. They have not responded. If they had, I would have provided the information (as I made sure in advance that they knew the context of the request - i.e. validating information from this forum).

Today, I called Autifony. I am not going to relay that information, because:

1. They are more competent at that themselves and I am not their representative,
2. The information is due no later than Wednesday in any event.
3. You already have a mail from a study site (released word-for-word: what more do you, or others, really need?)

 

[valeri]

I don't mean any disrespect, but if you have facts directly from Autifony, just share them already please. Enough of this "I know a secret that I can't tell you" stuff. I'm sure Autifony doesn't want any info released before they're ready, which makes me wonder why would they tell you? Sorry I sound like a ****, but this is frustrating.

I wanted to say the same thing yesterday!
This is not the time to play "word games"!
Information should either be shared or nothing should be said at all.

 

[Aaron123]

I don't have a citation, but I believe they are allowed to look at data - not the clinicians, but statisticians on the back side. Obviously they need to do so if there is an adverse outcome, but they can also do preliminary analysis. In the last few weeks there was a big study - maybe cholesterol or BP - that was stopped early due to positive results. My understanding is that any such analysis should be scheduled ahead of time which makes it a little odd to come so close to the scheduled end of the trial - if this is what happened. (A google search will show that there is some debate on stopping trials early for either benefit or futility.)

Operating under the assumption for a moment that the results suggest the drug is not effective: 1) I wonder if 28 days is too short of duration of treatment and if a second phase 2 trial of longer duration could be started rather quickly. I believe there was already some talk of a second Phase 2 trial before this latest news. That discussion was about finding the "optimal" dose, but it could include duration. 2) If it is not successful for T, perhaps that calls into question the trial for hearing loss. However, if that trial is successful and AUT00063 is approved for hearing loss, then it would be available for T as an off-label use.

 

[RaZaH]

I guess its disappointing if this is indeed deemed as not working but expectations need to be managed as well.
We really need to be more careful of overhyping any potential remedy for this affliction as false hope is a very cruel thing as I am sure most people with T have experienced.

Also if this is indeed connected to the drug Trobalt we know that it takes time to work.

 

[mcgregor]

I have contacted one of the test centres today and have been told that the trials have stopped because the drug is inefficient and is not giving good results to the participant of the trial, so it looks like its not working

 

[Aaron123]

It seems very unprofessional to me if in fact staff at the trial sites are giving out information about why the trial is stopping - whether they are right or not.

 

[attheedgeofscience]

We can thank our reputable associations who haven't lifted a f.....g finger at rising awareness let alone did something for the cure of this hell.

This is not true... in all cases, at least. With their limited resources, the BTA tries to make a difference. Here is a recent example of their "plug'em" campaign:

www.plugem.co.uk

In addition, the BTA "showed up" at TinnitusTalk for a Q&A:

www.tinnitustalk.com/threads/british-tinnitus-association-q-a.7746

And... they also support one of the tinnitus researchers:

www.tinnitus.org.uk/meet-the-researcher-dr-roland-schaette

We all wish there would be more effective therapies, but, as I pointed out today, the tinnitus community itself is lethargic (re: just ONE CLICK with a mouse button...).

attheedgeofscience
12/OCT/2015.

 

[attheedgeofscience]

It seems very unprofessional to me if in fact staff at the trial sites are giving out information about why the trial is stopping - whether they are right or not.

Think about it...

If Autifony - for one reason or another - is forced to terminate the trial, they have to inform the study centres. In turn, the study centres have to cancel the enrollment. And... the only way they can do that is to... call the folks who enrolled in the trial! Now these participants have a mouth, and, they also have fingers - which means - that they can type/share information. And that they do. Here on TinnitusTalk...!

 

[MidnightOilAudio]

If one goes here: http://www.autifonytherapeutics.com/autifony-tinnitus-quiet-study.asp and reads the 3rd question down, one can see that the 28 day duration was planned. With regards to the efficacy of the drug, I obviously cannot comment, but I think we can safely put the matter to rest as to WHY it was stopped after 28 days.

 

[attheedgeofscience]

but I think we can safely put the matter to rest as to WHY it was stopped after 28 days.

The 28 day period refers to the treatment duration. Not the trial duration (which is the topic of discussion).

 

[MidnightOilAudio]

aaaaaaaand I'm an idiot.