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

[dan]

An email reply I got from Autifony in response to questions posed by Amandine...

We are certainly reviewing the specific requirements for hearing loss - still under discussion and no decisions yet.

Every centre has to do audiograms up to certain specified frequencies. They may also (optionally) go higher and generate further information of value adn great interest.

063 seemed to eliminate tinnitus in the preclinical models. However, in the clinic, because of the heterogeneity of the tinnitus subjects within the study, we anticipate a spectrum of outcomes if there is benefit demonstrated- but so far we have no data and so cannot state anything categorically. This is the first study in tinnitus and we shall learn lots about how to move forward.

 

[Freddie]

@amandine

The selection criteria can be seen here
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB

I just phoned the contact number and was told that I need to get a referral from my GP if I want to be considered for selection. They took my details and asked me a few basic questions (How long have you had tinnitus for? etc..). They say that I need a referral before they can give further consideration to my application. TBH, I think my chances are slim.

Hi PhilB, just tried to call the number in Belgium but cannot seem to get through, what code were you using.

Thanks

 

[PhilB]

@Freddie
I am in Manchester so I phoned the nearest participating hospital which is Salford Royal. If you are in Belgium, you will need to prefix the number with the UK international dialing code (44) but I expect you are already aware of that.

 

[amandine]

@PhilB

@Freddie is in London. He is trying to phone the number in Belgium which is in the following document on the link

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB

He thinks that you phoned Belgium...for info....

 

[PhilB]

@amandine
OK, thanks for clearing up the confusion...

 

[amandine]

@Freddie

Try putting the intl code in front of the number of 0032 and then the number
or send an email
feel free to try to get info - and please report anything that you hear from them.
or dont bother judging by the ''informative'' response to the email quoted above by @dan
looking forward to hear from you re any info you may obtain....

 

[Freddie]

@Freddie
I am in Manchester so I phoned the nearest participating hospital which is Salford Royal. If you are in Belgium, you will need to prefix the number with the UK international dialing code (44) but I expect you are already aware of that.

Hi PhilB no I am based in London but I did manage to get through a few moments and the switchboard said that there was no one in that department today as she thought they were in London and to try again tomorrow, I need to find out what is going on at the UCL London as nothing is up there for contacts numbers yet .?

 

[PhilB]

@Freddie - It seems odd that a contact phone number is listed for some participating hospitals but not others. Also, I think I recall seeing a QEH Birmingham number listed on the Autifony site yesterday but it has now disappeared. Even so, I would imagine that you need a GP referral to get on the trial even for those hospitals which do have a number listed. The person I spoke to at Salford Royal told me that this particular trial is unusual in that respect. As I understand it, many NHS trials will allow direct enrolment without a GP referral.

 

[amandine]

@PhilB

Maybe it is to do with residency in england.
Registered with a gp shows residency and having an NH number shows residency also.
Or maybe cos the drug has some side effects and they want dr to send health report
dont know
mind you, what the gp's know is not too much to be honest

 

[tomm]

Called various numbers at UCL. They don't have any information at the moment on who your GP should be talking to after referral at the moment.

 

[Freddie]

@Freddie - It seems odd that a contact phone number is listed for some participating hospitals but not others. Also, I think I recall seeing a QEH Birmingham number listed on the Autifony site yesterday but it has now disappeared. Even so, I would imagine that you need a GP referral to get on the trial even for those hospitals which do have a number listed. The person I spoke to at Salford Royal told me that this particular trial is unusual in that respect. As I understand it, many NHS trials will allow direct enrolment without a GP referral.

Hi PhilB I think you are right about Belgium as to me that sounds odd as well and I noticed like you that with Birmingham the number is no longer there as I rang the yesterday and someone answered who took all my details and basically said that they were not ready just yet but would call back , I wonder ?

Any way last night I wrote a letter to my GP re the referral for UCL as that is what they are asking for but then where do I take it or send it, ? I have emailed the Autifony site a few times on this question but no reply so lets see what happens, probably like you I am looking at every avenue, keep in touch.

Thanks

 

[amandine]

@tomm
the whole thing is a bit of a disorganised joke at the moment.
Wigan told me they have been running the trial for a month already.
However tomm i can see that u are going the whole hog.....am 101 injections i think that u completed about a week ago.
No effect - placebo maybe?
then u are looking to get on the autifony trial....restriction exists if you have been on another trial - must be completed at least one month before new trial starts
And on top you would like to take trobalt.
Well it cannot show up in your bloodtests otherwise you will not get in
By the way, when i spoke with wigan yesterday they told me i have to wiat till it is at least 6 months old.
So you must wait till next april 15
she said they will not discuss or accept any registration until it is 6 months..

 

[tomm]

@tomm
the whole thing is a bit of a disorganised joke at the moment.
Wigan told me they have been running the trial for a month already.
However tomm i can see that u are going the whole hog.....am 101 injections i think that u completed about a week ago.
No effect - placebo maybe?
then u are looking to get on the autifony trial....restriction exists if you have been on another trial - must be completed at least one month before new trial starts
And on top you would like to take trobalt.
Well it cannot show up in your bloodtests otherwise you will not get in
By the way, when i spoke with wigan yesterday they told me i have to wiat till it is at least 6 months old.
So you must wait till next april 15
she said they will not discuss or accept any registration until it is 6 months..

Yep seems like it is a bit new for everyone involved. No effect for AM-101, no side effects either so thinking it was placebo.

By the time Autifony get their study arranged I'm confident at least a month will have passed. It's already been a week. I'm contacting the Autifony people to find out if 6 months it's a strict rule. If it is, then ok. I have to try - some other rules about hearing loss seem to be variable.

I'm trying everything - want my tinnitus to go away very much!

 

[amandine]

@tomm
I can assure you now that 6 months is a strict rule.
Also, it must be 30 days since you participated in another trial for example. So if you finish your 3 months with am 101 then you must wait another month before you can go onto autifony. So you have 4 months less a week or two before u can go on autifony.
But this will mean that you wont be able to get the real drug offered by am 101.
Unless you try for autifony and if you get rejected then go to am 101 for the real drug.But if they find out you will be kicked off. Please remember that with autifony it is 50 /50 whether u get real drug or not.
And then the trobalt in between?
I dont blame u for trying everything
I am getting to the point that if i dont get something somewhere then i am going to be drastic

 

[Lisa88]

Hi PhilB I think you are right about Belgium as to me that sounds odd as well and I noticed like you that with Birmingham the number is no longer there as I rang the yesterday and someone answered who took all my details and basically said that they were not ready just yet but would call back , I wonder ?

Any way last night I wrote a letter to my GP re the referral for UCL as that is what they are asking for but then where do I take it or send it, ? I have emailed the Autifony site a few times on this question but no reply so lets see what happens, probably like you I am looking at every avenue, keep in touch.

Thanks

Freddie, would you keep us posted. I know the UCL location and instructions seem a bit vague. I might be interested in having a go, if they somehow become more relaxed on the average hearing loss, which judging by the posts on here may be a possibility. Cheers.

 

[Danny Boy]

That doesn't make economic sense. If people hear there is a cure for tinnitus, they will flock to the pharmacy for this pill. If people hear that there is a new treatment, but you have to stay on it for life, lots of people will decide to keep "living with it". Plus, people aren't going to stop developing new cases because there is a cure, if anything they'll get sloppier about noise protection and there will be more new cases than ever. There are plenty of new and recurrent cases every year to keep Autifony in the black for decades.

To be honest, it doesn't make economic sense to cure people. If I had a business, I'd rather people take a tablet for life than for one month, as then I'll rake in more money. And lastly, people will just live with it? I don't think so...People seek relief all the time.

 

[rtwombly]

And lastly, people will just live with it? I don't think so...People seek relief all the time.

They will and do, though. We forget on this thread that we are all exceptional cases, people who either through personality or level of suffering are unable to put up with a condition that far more people have than even we are aware. I've been married for 15 years and only found out in January that my wife has tinnitus. Hers is intermittent, so easier to ignore, but if I'd had it in exactly the same way I'd have been complaining to family, going to every doctor I could think of (just as I have since January) and generally making a nuisance of myself all along. I'm a "let's fix this" type of person. She just takes what comes.

But really I'm just trying to tell you not to suspect bad motives of anybody at Autifony or any of these hospitals. It's hard to accept that there are some things no human on earth can do for you, but it is nonetheless a fact. We went into this century thinking that all our problems would be solved by stem cells just like people of the last century went in thinking all their problems would be solved by industrialization. These things take time. Nobody is sitting on a pile of miracle cures and holding them back for fear of economic instability...or if they are, they're not affiliated with Autifony or the NHS.

 

[rtwombly]

Heh. I didn't mean to kill this thread off so thoroughly. Almost a day with no new posts?

@tomm and @amandine and anybody else trying to get info, have you tried contacting the coordinator or lead researcher directly?

Professor Jaydip Ray, ENT Surgeon at Sheffield Teaching Hospitals & Sheffield Children's Hospital, has agreed to act as the national Coordinating Investigator. Our lead academic collaborator is the University of Nottingham (Professor Deborah Hall).

Anybody with ties to U. Nottingham?

 

[tomm]

Heh. I didn't mean to kill this thread off so thoroughly. Almost a day with no new posts?

@tomm and @amandine and anybody else trying to get info, have you tried contacting the coordinator or lead researcher directly?



Anybody with ties to U. Nottingham?

Yep I was digging for that info - got a Dr Schaette who used to belong to T UK and said he was getting calls about this today but didn't know anything about when the trial would be set up or who is doing it. Very nice - I felt bad bothering him!

Anyone actually get through to anyone or a sign-up yet?

 

[Mark662]

an email I had today about the Autifony Trial from Action On Hearing Loss. It's mainly what we already know and the trial goes to April/May 2015

http://www.actiononhearingloss.org....pyHeFOiVE2/2K1/x/ryOTKs/iWewQ5FTBtFIJ6ScA3zAt

Mark

 

[rtwombly]

an email I had today about the Autifony Trial from Action On Hearing Loss. It's mainly what we already know and the trial goes to April/May 2015

http://www.actiononhearingloss.org.uk/community/blogs/our-guest-blog/successful-partnerships-bring-a-boost-to-uk-hearing-research.aspx?CC=SoundbiteNovember2014&utm_source=Communigator&utm_medium=Email&utm_campaign=Soundbite - November 2014&utm_term=Vagus nerve stimulation - a new treatment for tinnitus?&utm_content=181347&gator_td=t1Xduv/F+ayc58fihqVEgN/UT9mdYkRKOXeX0OelEEYUcLFKxXbrj2DBq0DFYT7hCcZ+SdAgLkxzxpZWvouOzlIxZmAG0r5I+kaCEEfZBoRPZovEKCW1xZaE9ibU4hqQJbijaPbDx1fByqF2x64pyHeFOiVE2/2K1/x/ryOTKs/iWewQ5FTBtFIJ6ScA3zAt

Mark

Nice contact info there, but it sounded like they were saying recruitment could go up to March/April.

I've know this has been discussed, but do we know who here meets the hearing loss (and UK citizenship) requirements? Is there anybody who hasn't posted since the contact information went up?

Anybody a member of http://www.reddit.com/r/tinnitus/? I don't especially want to join just to ask about candidates for the trial, but there are 1278 people over there....

 

[Mark662]

@tomm are you saying that Dr Schaette knew nothing about the Autifony trial when you spoke to him?
Mark

 

[tomm]

@tomm are you saying that Dr Schaette knew nothing about the Autifony trial when you spoke to him?
Mark

That's correct. From what he said he's nothing to do with it.

Anyone got anything from Birmingham?

 

[amandine]

@rtwombly

yes i fit the criteria. perfectly. Just need somewhere to stay in uk and i can register and fitting the criteria will get into the trials.
Any offers? Does anyone have a house, apartment , room, anything to help out. Please.
It is not requred for long and anyhow I shall find my own permanant accomodation.
But I fit into this criteria for this trial - and can report back to this forum.
there is an offer to do this trial....on the table.....
I have discussed this with someone else and yes I am a perfect candidate for autifony....

 

[Danny Boy]

@rtwombly

yes i fit the criteria. perfectly. Just need somewhere to stay in uk and i can register and fitting the criteria will get into the trials.
Any offers? Does anyone have a house, apartment , room, anything to help out. Please.
It is not requred for long and anyhow I shall find my own permanant accomodation.
But I fit into this criteria for this trial - and can report back to this forum.
there is an offer to do this trial....on the table.....
I have discussed this with someone else and yes I am a perfect candidate for autifony....

You still need to wait till you've had tinnitus for 6 months.

 

[SteveToHeal]

@rtwombly

yes i fit the criteria. perfectly. Just need somewhere to stay in uk and i can register and fitting the criteria will get into the trials.
Any offers? Does anyone have a house, apartment , room, anything to help out. Please.
It is not requred for long and anyhow I shall find my own permanant accomodation.
But I fit into this criteria for this trial - and can report back to this forum.
there is an offer to do this trial....on the table.....
I have discussed this with someone else and yes I am a perfect candidate for autifony....

How do you know you fit the hearing loss criteria? Has you audio confirmed that. Good luck!

 

[amandine]

@SteveToHeal

As far as I know I fit the bill.
Although how it works out when they take an audio and do their calculations to achieve a an average number I really dont know or understand.
All I know is that I was told, when I gave my results from my hearing test, that I would potentially be a suitable candidate.

Anyhow we have been told that there are currently discussions to drop the hearing criteria. Great. But it seems a bit late in the day to be discussing such issues when the fujl blown trial is expected to start nowish and I was told by Wigan that their trials had been going on for a month already.
If they are changing their critieria after people have been accepted and tested on it already at least in Wigan Hospital, does that not then interfere with the trial results?

Seems a bit of a shambles at the moment.....
But as the weeks progress I am sure that it will become much clearer to us all.

And the length of time the trial is running is quite short - till May 15 max i think. Also according to Wigan. Woman there told me they would be accepting trialees until may 15. So it must finish in June 15?
However we dont know if she knows what she is talking about do we? Even though she is deeply involved with the trial at wigan, she may indeed not know what she is talking about?
All we can do is ring around all the study centres and get the info they give out and release it here and compare notes.
The more the same info is repeated from many study centres, the more likely it is to be correct.
That is all we have cos autifony are being very cagey with their response and dr large would make a great politician.

 

[rtwombly]

Don't read too much in, @amandine. Autifony has been consistent in saying they expect they'll have plenty of trial candidates and will address the hearing criteria if there is a need. They're not waffling there, it's the same answer I got months ago from the CMO. Try not to take it personally. They're trying to fill a 150-odd person study; they've no reason to be any more flexible than they already are but they've also no reason to shut anybody down with a hard NO. We've just got to see how the enrolment goes.

 

[tomm]

Has anyone else got a slot at any of the centres?

@amandine, did you get into Wigan via the number on the Autifony site - straightforward?

 

[amandine]

@tomm
hi
my shortest post!
yes
phone - number - old technology but still works well....lol
but they are not interested in talking tomm until the person has had t diagnosed for at least 6 months - you wont be 6 months tll april 15 and they finish recruiting in may 15.

by the way tomm how are you doing now ? any reduction in your T since the injections?