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

[skoupidis]

There's more profit to be made in a life long treatment course, than a cure in one month.

This is a long discussion. There are scientists and Nobel prize will come to them for finding a cure. It is always a life goal for them. You cannot deny this or you don't know what it is to be a scientist. On the other hand there is the company profit. They are merciless soulless coops. But they cannot control scientific discovery. They have to follow and compete each other. There are many parameters to consider than just suggest they "hide the cure that already exists"... I was never a big fan of such conspiracy theories.

On the other hand, there is the question of time and stalling, that may be of importance here. There are scientific breakthroughs in hearing loss that are lost at the stage of finding a pharmaceutic companies to provide the means to put the discovery to practice, especially in humans. The latest example is that of the regeneration of the synaptic connections between hair cells and neurons (Gabriel Corfas, University of Michigan's Kresge Hearing Research Institute). Until their finding in October 2014, no more news can be found on the net! There is an interesting article here and nothing more. That may suggest nothing but things do move really slowly, if they move at all!

 

[Danny Boy]

This is a long discussion. There are scientists and Nobel prize will come to them for finding a cure. It is always a life goal for them. You cannot deny this or you don't know what it is to be a scientist. On the other hand there is the company profit. They are merciless soulless coops. But they cannot control scientific discovery. They have to follow and compete each other. There are many parameters to consider than just suggest they "hide the cure that already exists"... I was never a big fan of such conspiracy theories.

On the other hand, there is the question of time and stalling, that may be of importance here. There are scientific breakthroughs in hearing loss that are lost at the stage of finding a pharmaceutic companies to provide the means to put the discovery to practice, especially in humans. The latest example is that of the regeneration of the synaptic connections between hair cells and neurons (Gabriel Corfas, University of Michigan's Kresge Hearing Research Institute). Until their finding in October 2014, no more news can be found on the net! There is an interesting article here and nothing more. That may suggest nothing but things do move really slowly, if they move at all!

Well, can go either way then.

 

[sakrt]

There's more profit to be made in a life long treatment course, than a cure in one month.

Much agreed. It's all about profit. They were awarded Millions for their short Study to be completed as of June 2015 (2 months). Interestingly, they're still looking for/"recruiting" those 150 patients! Seems there's not many that fit their specific criteria I suppose. All correlated to "reduced activity at certain sites of the brain".
https://clinicaltrials.gov/ct2/show/results/NCT02315508?term=tinnitus

Their focus is on "age-related loss of hearing or tinnitus(a 'ringing' or buzzing noise in the ears)"
and one's a candidate ONLY if it existed for not less than 6 months, and not more than 18 months. (??) So, how do they know if a candidate is dishonest or can remember?
I predict the main focus of this project is to create an addictive pill for baby-boomers/seniors in UK & USA who don't want to wear their Miracle hearing-aids.

 

[Danny Boy]

Much agreed. It's all about profit. They were awarded Millions and their short Study is to be completed as of June 2015 (2 months), however they're still looking for/"recruiting" those 150 patients! Seems there's not many that fit their specific criteria I suppose. All correlated to "reduced activity at certain sites of the brain".
https://clinicaltrials.gov/ct2/show/results/NCT02315508?term=tinnitus

Interesting, the focus is on "age-related loss of hearing or tinnitus(a 'ringing' or buzzing noise in the ears)"
and one's a candidate ONLY if it existed for not less than 6 months, and not more than 18 months. (??) So, how do they know if a candidate is dishonest - just to get on this trial?
I predict the main focus of this project is to create an addictive pill for baby-boomers/seniors in UK & USA.

Well, they wouldn't take me as my hearing is too good. Rather silly if you ask me.

 

[skoupidis]

Well, can go either way then.

I can only say this: I think something would come up, someone would talk if they found something big.
There are just not enough evidence to support foul play. But stalling? Where to invest money? That is of essence too. Perhaps finding a cure is of no interest while temporarily alleviate the symptoms may be a better suit for them.

Still, talking about tinnitus, thing may be different than other diseases. Tinnitus is rather delegate, it does not kill, it merely destroys quality of life. People try many drugs on it, it is resilient! I really doubt they can find something temporary that really works for most patients while not curing the condition. This is why I am not a big fan of, lets say, Retigabine... It simply does not work at all for many people. How could it? It doesn't cure. I am absolutely sure if I try it it will do NOTHING to me.

 

[Tinnitus Talk]

Everyone please stay on topic.

This thread is about the Autifony AUT00063 Phase II study.

Off-topic posts will be moved or removed without notice.

 

[attheedgeofscience]

The only subjects accepted are ones who only had consistent "buzzing" of up to "6mos and no more than 18 mos." with NO other sinister or health issues. Realistic? Transparent?

Regarding consistent buzzing. If the investigator of the study was to accept participants with also intermittent tinnitus it would potentially cloud the picture as to the efficacy of the drug. For instance, in the event of an improvement, how would anyone be able to say if it was the drug or just the natural cycle of the patient's tinnitus? That's why a specific sub-group of patients is required in order to evaluate the drug to the highest standards possible. That would not rule out that in a post market release of the drug also patients with intermittent tinnitus could be prescribed the drug, perhaps, but in terms of the trial itself, a strict protocol has to be followed.

Regarding the time frame aspect for onset of tinnitus. Again, the investigator is looking for a specific sub-category of patients. The AM-101 trial focused on the acute stage segment (due to certain processes which are believed - but not proven - to occur in the brain after a while i.e. chronicity). Autifony Therapeutics have chosen a different segment of patients - presumably because their drug is geared towards another group of patients. That time frame may be expanded to include other patients later on in a phase-IIb trial, for instance (once basic efficacy has been demonstrated). Auris Medical did the same thing (i.e. included a sub-acute segment of patients...).

Realistic? Transparent? Well picture this... if you swallow 600mg of Ibuprofen and 30mg of Codeine at the same time, how would you know which medication contributed with a certain pain reducing effect? Difficult to say, right? So in my opinion, the specific inclusion/exclusion criteria provide a high degree of transparency (for the benefit of proving efficacy and hence ultimately providing a drug to the tinnitus community).

Here are some snapshots of the forms presented to people enrolling with the trial:

www.tinnitustalk.com/threads/autifony-therapeutics-phase-ii-study-for-aut00063-for-the-treatment-of-hearing-loss-and-tinnitus.6516/page-27#post-88815

Take a look, you might actually learn something (about the trial).

attheedgeofscience
10/APR/2015.

 

[sakrt]

@Shaun and @PhilB
in case it is of interest to anyone i've attached the participant info sheet i got sent from autifony. hopefully you can read it. i'm eligible to come in for a screening appointment, here's hoping my hearing is worse than i thought : )

2131e: How did your screening assessment go? Only had T for a short time?
And, PhilB, who didn't have to do a hearing test, nor was disqualified for being on antidepressants (which is under their list of disqualifications, but was accepted?)

As indicated on Autifony's site:
Awarded Millions for their short-term study of another yet unapproved drug to be completed as of June 2015
(2 months). Interestingly, they're still looking for/"recruiting" those 150 patients! Seems there's not many that fit their specific SMALL criteria https://clinicaltrials.gov/ct2/show/results/NCT02315508?term=tinnitus
Do you meet their short-list criteria? (may be tweaked like with PhilB). You qualify GREAT!
Or are you one under the LONG list of disqualifications as most T sufferers (including Veterans)? Won't work.

 

[valeri]

There's more profit to be made in a life long treatment course, than a cure in one month.

Who really cares!
Give me a noise reducing pill and I will take it for life!
If they can invent it I'm happy to pay for it!

 

[Danny Boy]

Who really cares!
Give me a noise reducing pill and I will take it for life!
If they can invent it I'm happy to pay for it!

Well, that's that new keppra drug which should be out soon...

 

[valeri]

Well, that's that new keppra drug which should be out soon...

What new kepra?

 

[Danny Boy]

What new kepra?

It's called brivaracetam and it's basically a more potent version of keppra 10x more in-fact.

 

[PhilB]

And, PhilB, who didn't have to do a hearing test, nor was disqualified for being on antidepressants (which is under their list of disqualifications, but was accepted?)

Been away from here for a while and I am no longer a frequent visitor to this forum but I just wanted to state that I was eventually ruled ineligible to participate in the Autifony trial, despite initially being given the impression that I had been accepted. I attended two screening tests and was given a hearing test at the second appointment. However, the reason for my disqualification was nothing to do with hearing loss or use of ADs (I had been on fluoxetine and came off it shortly before the first screening)- I was ruled out due to high blood pressure.

 

[Mark662]

Well, that's that new keppra drug which should be out soon...

Both these drugs are for epilepsy or being tested for it. Until a drug is released on the market specifically for tinnitus, we will still be at square one. It is wrong to make sweeping assumptions that they will have any effect on tinnitus, even with the positive experiences with retigabine in mind.

 

[Danny Boy]

Both these drugs are for epilepsy or being tested for it. Until a drug is released on the market specifically for tinnitus, we will still be at square one. It is wrong to make sweeping assumptions that they will have any effect on tinnitus, even with the positive experiences with retigabine in mind.

Sure. Let's forget about it.

 

[skoupidis]

Sure. Let's forget about it.

It's just that... It won't let you

 

[sakrt]

Been away from here for a while and I am no longer a frequent visitor to this forum but I just wanted to state that I was eventually ruled ineligible to participate in the Autifony trial, despite initially being given the impression that I had been accepted. I attended two screening tests and was given a hearing test at the second appointment. However, the reason for my disqualification was nothing to do with hearing loss or use of ADs (I had been on fluoxetine and came off it shortly before the first screening)- I was ruled out due to high blood pressure.

PhilB: Thanks for the update. It appeared you were accepted but clarified as not. I appreciate it. I hope your T has improved?
Has ANYONE on this whole forum been accepted to this study?
Their short-list criteria, is unrealistic for the general population w/ T, therefore allows this million $$ clinical trial very easy to pass the drug to market, with no-one knowing how it affects those under their long disqualification criteria. So, when it is, and ENTs start prescribing to desperate sufferers like Valeri (who will take it no matter what). No one questions the drug's side-effects to those under the unaccepted criteria or it simply doesn't work?
A reasonable question to ask about - how they run these sort of trials. Last thing one needs, is T with cancer.
Autifony's still recruiting as stated on their website. The study ends in June 2015. You'd think if they could not find at least 150 subjects after 1.5 yrs to fit their criteria in all of UK & outside - the trial should be extended to demonstrated valid documentation.

 

[PhilB]

I hope your T has improved?

Thanks for asking. I am pleased to say that over the last few months I have become much better at ignoring/disregarding my T. It is still there and occasionally intrusive but I am much less bothered by it now. Can't put my finger on any specific reason for the improvement - maybe just proves that time is the best healer.

 

[RCP1]

@PhilB

Good result..

 

[Juan Carlos]

Thanks for asking. I am pleased to say that over the last few months I have become much better at ignoring/disregarding my T. It is still there and occasionally intrusive but I am much less bothered by it now. Can't put my finger on any specific reason for the improvement - maybe just proves that time is the best healer.

From my experience i know that rate T on silence is very tricky and difficult, so if u are less botherer could be also that the level is lower. Are u able to compare to a minium masking level of after and now?
in my case, after 1 year of T, now i surely know that i am much less bothered, but for example, i was equal bothered on month 3 than month 9, but after taking RTG im much less bothered, still not sure 100% what happened -RTG helped me to habituate or -RTG actually lowered volume
are u able to know the difference?
i reach days, specially on weekend, that my "total time thinking of T per day" could reach like 10 or 20 minutes, rest of day is absolutely like 'my good days'

 

[PhilB]

if u are less botherer could be also that the level is lower. Are u able to compare to a minium masking level of after and now?

Hi @Juan Carlos - no I don't think the level has changed at all since my T first began, the difference is the result of spending less time thinking about it. When I listen for it, T is still there and still just as loud. Over time, there has been a gradual change is my perception of T. I do not feel threatened or scared by it any more. I am not saying I feel 100% cured. T is still annoying sometimes but not such a big deal for me as it once was. I am glad to hear that you are also doing better these days.

 

[Danny Boy]

Hi @Juan Carlos - no I don't think the level has changed at all since my T first began, the difference is the result of spending less time thinking about it. When I listen for it, T is still there and still just as loud. Over time, there has been a gradual change is my perception of T. I do not feel threatened or scared by it any more. I am not saying I feel 100% cured. T is still annoying sometimes but not such a big deal for me as it once was. I am glad to hear that you are also doing better these days.

Did you get any side-effects as that is a tail tail sign of placebo?

 

[lapidus]

Did you get any side-effects as that is a tail tail sign of placebo?

You must've misunderstood. @PhilB havent been in the Autifony trial.

 

[Danny Boy]

You must've misunderstood. @PhilB havent been in the Autifony trial.

Oh, sorry! I was confused.com right there.

 

[NGC891]

For those who wish to know more about the molecule ...

AUT00063 patent...

http://www.google.com/patents/US8722695

 

[Danny Boy]

For those who wish to know more about the molecule ...

AUT00063 patent...

http://www.google.com/patents/US8722695

View attachment 5938

Wish I could get china to make some some lol.

 

[Danny Boy]

Wish I could get china to make some some lol.

Anyone willing to try it lol?

 

[skoupidis]

Danny Boy stop quoting yourself! And stop relying on everything written on the net.
Made it, tried it, got cured.
Satisfied?

 

[Juan Carlos]

For those who wish to know more about the molecule ...

AUT00063 patent...

http://www.google.com/patents/US8722695

View attachment 5938

It can't be too dificult to discover the variables, some expert over here? after that, ¿what cannot be bought with money? we are many and maybe we can make some deal to some chinese lab, some in the forum already bought RTG via this way... better try than waiting 5 years...

 

[ruben ruiz]

To heck with using animals. Use prisoners in the system with the malady. Fork them some money for their families.
I bet there would be plenty of volunteers!