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

[locoyeti]

Who knows what's going to happen we will just have to wait and see

hi @chamferman, thanks very much for the update. is there anyway you would be able to run into any of the other trial participants? if so, asking them how the are doing with the trial and the effectiveness of the drug for them would be some great info to gleam. also, i think if you were to ask any of people running the trial how it is going for the other participants, there is a chance they might tell you how they are doing, or how successful the drug has been so far. i remember when i was in the am-101 trial, the people running the trial were very forthcoming with information.

 

[Tj5685]

Hi every one not used to these fourams ive had tinitus since jan 14 and has been asked to try a study aut 00063 any views on this just want it to stop

 

[nills]

Hi every one not used to these fourams ive had tinitus since jan 14 and has been asked to try a study aut 00063 any views on this just want it to stop

Do it, you have nothing to lose ... If you want to know more about it read this whole thread! good luck

 

[Martin69]

Hi every one not used to these fourams ive had tinitus since jan 14 and has been asked to try a study aut 00063 any views on this just want it to stop

Of course do it. The earlier, the better. And keep us informed.

 

[Tj5685]

I'm gna do just that thanks I've to go down feb the 10 for bloods and stuff fingers crossed Dnt know how much more I can take

 

[Rube]

I'm gna do just that thanks I've to go down feb the 10 for bloods and stuff fingers crossed Dnt know how much more I can take

Good luck and hang in there. Please let us know any details on the screening and if you start the trials.

 

[Isabella 123]

Does anyone know how a drug that makes it to market in another country gets approved to be available in the US? I'm thinking if Aut-63 becomes approved in the UK, how long and how will it be available to Americans? Does the FDA have to approve it? Anyone know?

 

[joejunior]

If this drug works, and thats a big if, there will be overwhelming demand for it and it will have to go down a fast track proccess.

Tinnitus sufferers have been neglected too long and the demand will be there to fast track it asap.

Lets face it this is a trial of AUT63 vs placebo, not best available current treatment. why?because there is none.

 

[Viking]

If this drug works, and thats a big if, there will be overwhelming demand for it and it will have to go down a fast track proccess.

Tinnitus sufferers have been neglected too long and the demand will be there to fast track it asap.

Lets face it this is a trial of AUT63 vs placebo, not best available current treatment. why?because there is none.

I distrust autifony. They have only made a lot of noise. We do not need others noise. They have very few economic resources, and are experiencing a drug purely based on the principles of auditory hallucinations caused by schizophrenia. In the past I have been on trial neramexane. 50 million dollars of funding than 2,500.000 of autifony and we were constantly assisted and PAID!
They will not even allow a single trial outside the UK .... I do not like this story

 

[Isabella 123]

So because it's (assumably) the only
medical treatment for T, it won't be a long process? I'm also assuming that since Autifony is spun off GlaxoSmithKline and also backed by Pfizer, they will have some clout in getting it to American markets pretty quickly. Just fantasizing a bit here...

 

[marqualler]

So because it's (assumably) the only
medical treatment for T, it won't be a long process? I'm also assuming that since Autifony is spun off GlaxoSmithKline and also backed by Pfizer, they will have some clout in getting it to American markets pretty quickly. Just fantasizing a bit here...

Well, they are beginning testing AUT-63 here in the USA but for age-related hearing loss only. I contacted the nearest researcher and he responded to me this morning stating that at this time they are only testing the age-related hearing loss in the USA and tinnitus in the UK. Not sure if there is really any particular rhyme or reason that is outside the scope of what GSK / Autifony needs to do for their own company and the protocol they need to follow to carry out clinical trials. Admittedly I know next to nothing about how they work so I am purely speculating here, but do know that the drug is being tested in the USA for slightly different reasons than in the UK.

 

[marqualler]

For the record, here is his response (you can see Dr. Sladen's credentials here which is how I found his contact info):

Sladen, Douglas P., Ph.D.
11:09 AM (5 hours ago)

to Hughes, me

Hi Mark,

At this time we are only involved the application of AUT00063 for hearing loss. I believe Autifony has plans to study tinnitus, though at this time those studies are only being conducted in England.

Doug

 

[Isabella 123]

My DIL used to be a drug safety manager contracted to GSK. I've been keeping her in the loop with this and she believes that if GSK is involved it's definitely on the right track and I should be optimistic. But of course not count on anything because that's the reason they do the trials is to see what the trials reveal.

 

[RCP1]

@Viking. did you get any relief from neramexane? Just curious

 

[Viking]

So because it's (assumably) the only
medical treatment for T, it won't be a long process? I'm also assuming that since Autifony is spun off GlaxoSmithKline and also backed by Pfizer, they will have some clout in getting it to American markets pretty quickly. Just fantasizing a bit here...

Prifez is bankrupt. Are still paying fines and damages due to various promotion and improper use of gabapentin (mechanism of action ... unknow) http://www.nytimes.com/2004/05/13/business/13CND-DRUG.html.
http://www.farmacista33.it/crac-soc...agistratura/politica-e-sanita/news-49158.html Pfizer is tryng all in order to save... http://www.cityindex.co.uk/market-a...as-us-announces-crack-down-on-tax-inversions/ http://www.ansa.it/saluteebenessere...-chiesto-processo-manager-Pfizer_9860493.html Now, even those who have half a brain can understand one thing: if I tomorrow, with the approval of an institution like a university of medicine, I say to have made a scientific discovery, I already receive the first contacts for funding. Is a method for advertising and receive money. And if the drug works, the first companies who bought the rights to the research, will see their stock certificate skyrocket obtaining a lot of money. This is the principle of exchange sales of so-called "derivatives". These are things that do not exist yet, but already create a virtual profit. Also: wht in the past, the trial study for SSRI meds was of a minor of 3 years? Why we have a lot of addictive drug like benzodiazepines APPROVED without trials?????
Ok i could continue to infinity. I'm just tired of being teased, for the economic well-being of others.
Sorry for OT
best wishes

 

[Moha94]

Viking you do not believe more in AUTOOO63 ?

 

[dan]

Viking you do not believe more in AUTOOO63 ?

It was a nice dream...

 

[preslys]

The trial started since october 2014
four months later we don't hear any real results .it's strange here.

 

[Viking]

It was a nice dream...

 

[Hotspur]

Hi guys,just been speaking to someone running the trial,this drug will be open to people with T longer than 18 months!The course will be longer!Hope thats made someones day!

 

[amandine]

Hi guys,just been speaking to someone running the trial,this drug will be open to people with T longer than 18 months!The course will be longer!Hope thats made someones day!

What do you mean that the course will be longer? Do you mean that they are going to carry the trials on for longer than they initially said ie to the summertime 2015 ? or do you mean that people are going to be taking the pills for longer than 4 weeks? and do you know anything about the hearing test getting easier or not? and the person you got this from is someone reliable who knows what he or she is saying? the person is actually in charge of running the trial? thanks

 

[RoadToSilence]

Hi guys,just been speaking to someone running the trial,this drug will be open to people with T longer than 18 months!The course will be longer!Hope thats made someones day!

Thanks Hotspur! This will be very good news to many. Of course, the obvious question is "How much longer than 18 months?" Also, thanks for your regular Aut63 updates - much appreciated!

 

[Hotspur]

What do you mean that the course will be longer? Do you mean that they are going to carry the trials on for longer than they initially said ie to the summertime 2015 ? or do you mean that people are going to be taking the pills for longer than 4 weeks? and do you know anything about the hearing test getting easier or not? and the person you got this from is someone reliable who knows what he or she is saying? the person is actually in charge of running the trial? thanks

Hi amandine,yes the person is someone from the hospital,who is in direct communication with the doctor from Autifony
Just been chatting about my course and try getting to get a bit more info!
This is supposed to give relief within four weeks for people between 6 to 18 months,if you have it longer,the course will be more than four weeks

 

[amandine]

@Hotspur
and when does the trial finish? do you know? Last I heard was July 15

 

[Robb]

Hi amandine,yes the person is someone from the hospital,who is in direct communication with the doctor from Autifony
Just been chatting about my course and try getting to get a bit more info!
This is supposed to give relief within four weeks for people between 6 to 18 months,if you have it longer,the course will be more than four weeks

I live in germany can I participate in anyway in a trial? Have T now for lets say 17 Months.
So when it hits the market is probably had T for lets say 5 Years, would it than still be effective? (of course we not know)

But when I read about aut00063 the idea was to give anyone relief of T through hearing loss or noise damage, isn't'it?

 

[Hotspur]

I live in germany can I participate in anyway in a trial? Have T now for lets say 17 Months.
So when it hits the market is probably had T for lets say 5 Years, would it than still be effective? (of course we not know)

But when I read about aut00063 the idea was to give anyone relief of T through hearing loss or noise damage, isn't'it?

Hi robb,im not sure,at a guess,if someones had it 18 months and the course is 4 weeks,maybe if youve had it 36 months the course is 8 weeks?

 

[Robb]

Hi robb,im not sure,at a guess,if someones had it 18 months and the course is 4 weeks,maybe if youve had it 36 months the course is 8 weeks?

Yeah if it will be like that.. i just hope the drug is able to revert or better that activity in the so called potassium channels, thereby creating the so hardly wished softening of the subjective T sound..

 

[jeannie]

Hotspur, is there any change in your tinnitus yet?how long have you been taking it now a week or two? hopefully you will send us good news soon!

 

[Hotspur]

I should also mention communication between Autifony and the hospital has not been great!
For anybody else doing this its 4x200 with breakfast!Hopefully chamerfans doing it right!
When i started,i was handed ONE pill and told taking with food not nessacary,i then presumed it would be One pill every 4 hours during the day,really thought it could have been quite easy to write directions on the bottle!
Anyway Autifony doctor doesnt think its too much of an issue ,and im now doing it the correct way!

 

[Mark662]

Could we possibly get an interim statement from Charles H. Large of Autifony to let us all know what is really happening with this drug and the current trial?

Is this drug supposed to be a cure to completely eliminate tinnitus?
If this drug were successful would it be taken as a suppressant that must be taken for life?
Are we doomed to not have any relief if we have had tinnitus for more than 18 months?
Also, if this drug was proven to be effective, how long before it goes onto the market?
Has a human subject with tinnitus ever taken this drug during its development and had relief?

I am being a little optimistic because I am sure not even he knows some of the answers to the above.