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

My average is 20.5 db for my right ear, which is the one that likes making funny noises. I can personally think of five other candidates who would qualify. Remember, this is a study for age related hearing loss in the US. I'm an anomaly, having hearing loss at that level at age 37. Of the other candidates I have in mind, one is my age group, the rest are my Mom's age. Come to that, Mom probably qualifies.

20 db is a mild hearing loss. I wouldn't have bothered getting my hearing tested had it not been for the tinnitus. I'm slightly strange for these forums in that my hearing loss is low frequency, but really, I don't think frequency has anything to do with tinnitus. It's auditory epilepsy, like Aristotle diagnosed thousands of years ago.

Dboy, thanks for posting that info. Though I still don't know if I'm old enough for the study or if my good left ear will knock me out of contention, right now I'm feeling much better about my chances.

Oh, and was the ENT in the US? Also congrats on finding a good one.

Edit: just did the math on my left ear and it's bang on 20 db. Skill all! Well, truth be told I don't see where the audiologist checked a few of the tones so a new test might look different. Bit crazy though, it is after all a completely subjective test. Maybe they don't mean to advertise the db range....

And one more thing! I doubt Autifony expects the before and after on most of the test to change. There really is no good reason AUT00063 would raise threshold scores. What it should do is allow people to understand speech better in their bad frequencies. Like when I can hear the TV from across the room but can't make out what the actors are saying. Interference from tinnitus, whether audible to the patient or not, obstructs the neural pathways that make sense of speech. So thresholds won't get better on the drug, but the test where they have you repeat sets of words like "base ball" and "hot dog" should improve.

 

It looks like this is only open to people in the UK though.

 

There are two trials, one in the UK and one in the US. The US trial is for AUT00063 as a treatment for age related hearing loss. UK trial is specifically for tinnitus. Because he mentioned hearing loss, I took it that dboy was talking about the US trial. Is that right, dboy?

 

Hi, sorry, forgot to check back here for a couple of days. I am in the UK and the trial is for tinnitus. The hearing loss thing was as an inclusion criteria for the tinnitus trial, which is partly why I found it odd. (Unless the ENT guy got his wires crossed and was looking at the wrong info or something. I've seen him quite a bit and have a lot of respect for him, but everyone makes mistakes!)

Yes, 20db is a mild hearing loss at any particular frequency. My assumption is that nobody has uniform hearing loss across the range - so if the average is above 20db then there will be frequencies where the hearing loss is much greater. I have hearing loss up to 35db at some frequencies on the tests they perform in the NHS here (i.e. up to 8kHz). And from being on the ANM trial and testing myself I know that my hearing drops quickly above 9k to nothing at all at around 12.5kHz.But my average over the specific frequencies required is <20db.

BTW yes, I believe the frequencies required for the average were all between 250Hz and 8kHz. 8kHz is the limit they test to and anything above that seems to be considered irrelevant. I have even had one (rather less competent) ENT doctor tell me that 'There is nothing over 8kHz'!

 

over 8khz, there's the final frontier...of hearing

 

Indeed! It is rather sad that that 'frontier' persists into mainstream care of tinnitus sufferers. Sure, for folks whose main problem is being hard of hearing, up to 8K is the important range where understanding of speech takes place as well as the majority of sounds we might need to hear in daily life. But the hearing loss associated with tinnitus and the tinnitus itself can be above 8K - and for many folks it is. Mainstream medicine seems incredibly resistant to acknowledging that in its practices.

 

I know @dboy
My Audiologist told me that the tests that go beyond 8khz is "bullshit" and "psuedoscience" and that they "don't prove a thing", so I guess the medical community has some kinda grudge with the people who came up with the new hearing test.

 

this only shows how little minded they are, hopefully researchers don't think in the same way doctors do

 

@dboy

CAN YOU CONFIRM ONLY UK RESIDENTS ARE ACCEPTED?
WHAT ABOUT US/CANADIANS?

 

It wpuld be nice if they said trial will last entire 24.

yes entire 24.

HOURS.

We all know know about nondisclosure agreement and suddenly all over ENT go bubbling info about Autifony.

 

FREE 30 DAY TRIAL - OR YOUR MONEY BACK -GUARANTEED!!!

 

I'm afraid I cannot confirm anything other than that I was told the things that I posted a few days ago.

Sorry, I am not sure I understand your post. The ENT doctor looked up for me whether I might be eligible for the trial and I subsequently posted what I learned on here thinking that (a) nobody told me it was sensitive or restricted info and (b) it might be informative for forum members who are hungry for info. I hope no harm has been done?

 

@dboy thank you for your input. Christian was just being silly - He does not believe an ENT could divulge such "secret" information.
I believe you are legit. If you hear anything else, let us know!

 

As I mentioned in my post earlier on, the trial is UK based (that was the information I got from Mr. Large a couple of days ago). Based on my direct knowledge of the AM101 clinical trial, I would assume with "99%" certainty that it means only UK nationals can participate (these are the rules of clinical trials as they need to have a basis framework by which they can ensure the participants understand the conditions of the trial ie. it is a language condition due to the paperwork participants have to sign).

However, as I am someone who dislikes to assume anything, I can give Mr. Large a follow-up call on Monday - no problem. But, I am so certain in my assumption, that I would not normally even bother (basically, I would just be doing it as a service towards this board; I know how these things work...).

When I looked up financial information on AUT00063 as mentioned in an earlier post, I did notice that Autifony had registered the same product twice over (which is unusual). It could therefore well be that they are doing two separate trials with separate admission criteria for each one ie. hearing loss/no hearing loss, tinnitus/no tinnitus - and possibly mixing these conditions (as the same medication is used for two separate inner ear pathologies). But again, it is best not to assume anything. And the conditions as to whom can participate will almost certainly still apply (ie. UK nationals for a UK trial, US nationals for a US trial).

This is of course a phase II trial, so the scope in terms of number of participants is not as great as with a phase III trial (probably around 300, I would guess). There would therefore not be a need to extend it to several countries in order to ensure sufficient participants...

I am surprised not more people have contacted Autifony (has anyone?). But as I say, I can follow up with a call on Monday (even though I know what the answer will be). Also, it is almost irrelevant at this stage; they will release all information in any event within the next 30 days (give or take...).

 

This was the same overall information I got from a senior physician at the University Hospital of Leipzig.

I have provided @Markku with a copy of the 2-page review the doctor wrote to my GP following that.

I doubt AM101 will be successful enough to make it to the market, but I am surprised Mr. Meyer would invest - was it 6 or 7 million CHF - of his own money in a project he didn't believe in...

 

@attheedgeofscience

Thank you for your great input to this board.
It would be nice to know for sure if non-UK residents could participate.
So if you can ring him up that would be great
As for the English speaking thing - what about people from Canada?
We speak the same language! (wtf) It's not too late they can always revise their criteria.

 

It's possible that participants from other countries where English is the official language can also participate - ie. Canadians in a UK trial. It is also possible that the admission conditions apply not based on official languages, but on other criteria such as "Colonies of the Former British Empire" (ie. the Commonwealth) - I believe the Queen of England is (still) the head of state in both Canada, Australia, New Zealand, and so on (if so, I can think of another member here @Amelia who might be interested - I will ask Mr. Large about this). All I know is that I won't be able to participate in the UK trial - and that's despite being an EU citizen. As an EU citizen you can basically move to any country you want to within the EU without filing any paperwork in advance (the government cannot deny you residence or work permit there - it's your right to move where you want to; so a person would assume that similar relaxed conditions should apply to many other things such as a clinical trial - but no...). I couldn't even participate in the German clinical trial of AM101 (even though I live here officially and I have official health insurance with a German health care provider) - that's why I had to go through all the "crap" with the AM101 off-label stuff that I wrote about earlier on (https://www.tinnitustalk.com/thread...ing-loss-and-tinnitus.1607/page-17#post-53876).

Anyway, enough about speculation, I will call tomorrow and ask the following:

1) What is the admission criteria for the UK trial? (ie. country of residence criteria as well as medical criteria ie. hearing loss or no hearing loss and time since onset of tinnitus - and yes, I will specifically ask about participants from Canada and Australia).
2) How long will participants need to stay in the country? - for the full trial or can they go back home after the initial "consultation" (remember the medication will then need to be taken back with you - and I am pretty certain that they would not allow that, and there could also be problems with the authorities when going through security checkpoints at the airport, and so on...). And also remember: this is a clinical trial - there are strict protocols for how everything needs to be processed and assessed (and this very definitely includes the medication...). A clinical trial forms the basis for medication that will eventually be released to the mass market - so everything single action needs to be followed to the very letter (as I am sure you know).
3) Is there a trial in the US - and if so, what is it?

I would also like to mention that pharmaceutical companies are actually not that interested in helping people with medical conditions during a clinical trial (that's not where their focus is). Their aim is to ensure that a reliable clinical trial is conducted and hence ensuring that reliable data is collected. No more, no less. People like you or me who don't fit their profile, and who are willing to go the extra mile, are just an annoyance to them really. I am sure you know that too.

On a slightly different note, I am now on day 4/5 of my Flupirtine "experiment" (potassium 7.x modulator). My tinnitus seems to be slightly lower in the morning - but it is way too early to make any conclusions. And honestly, I don't think the experiment will work (that's what my gut feeling tells me). On a positive note, the side effects of taking the high dosage of medication is rapidly going away - the medication is actually well tolerated (to my surprise - even at daily dosages of 400 mg). I don't feel sluggish anymore and there are no other issues either.

 

That is great. If we can get some first hand info on the Autifony trial for T in the UK, that would really help. I know they said "watch their website" in September, for info on all 3 points you are intending to ask on Monday. I hope you can get some answers and thanks in advance to be willing to feedback the info to the forum, if you find out that info.

 

What I meant was that drug cost trillions of dollars. Therefore every person who work there and it is part of research has to sign nondisclosure agreement.

I don't believe they pick ENT's on a street. I know legal rights and how does they work. A doctor who get into resech has to sign "a deal with a devil" because such agreements are so strong, and they take huge money if you brake it plus ruin your career. Therefore some ENT don't go speaking about research, and when ew ask Dr. Large he don't say anything. And Your ENT gives details, Dr. Large don't want nether to give hint. And then specially you put a pressure on your ENT and he gave you details.

Likelihood it is possible it is minimal.

 

@attheedgeofscience

Can you direct me to your post that tells how you regained some of your hearing loss? I'm not sure if it was from AM-101 or LLLLT. I apologize for posting this question here but I can't seem to send you a private message.

 

@attheedgeofscience It seems you have tried so many treatments, im kind of losing track. I read you did laser treatment, which improved your hearing (but not tinnitus). I see you're now trying Flupirtine.

I would love to see a post that contains your different treatments, how they worked for you, and your opinion of them. Your input to this forum is so massive, but very fragmented.

 

If I understand correctly you are suggesting that I have told lies to this forum. Tinnitus Talk has been a great benefit to me over the last year or so and I would not do such a thing. I have better ways of entertaining myself than that, believe me.

I understand you are having a hard time at the moment, but that is no reason to be rude. I will look forward to your apology when further information is forthcoming that confirms my posts.

P.S. You say "that drug cost trillions of dollars". That is more than the GDP of many developed countries. UK GDP was $2.435 trillion in 2012 according to Google; Autifony is a UK company. According to info posted by attheedgeofscience, Autifony has so far raised $25.4 million. Estimates of average drug development costs on Wikipedia seem to hover around the $1 billion mark. A lot of money without doubt, but a short amount of research nevertheless suggests that it is your information that is badly informed.

 

There is no need to apologize, because i said possibility is minimal, but that is not impossible, so there is possibility you releyd correct information from you ENT,or better say your ENT told you truth that you rewrote. That considered one who may be called strange is you ENT not you. And I am not in bad moment. I will write on this subject more, buy right not I am inquiring information. I apologize to you, but your ENT is suspicions, or bit strange or bit unreal, or bit illogical. In any way we will get real data soon when they announce information for trial.



PS: 15% of mankind have tinnitus, if we are going to use it permanently, incomes over year for company will be huge, that is what i meant. Please don't be angry, it is just ENT data were unrealistic, but again it is possible.

 

Sure, lets wind this down a bit and let the thread get back on topic.

 

@attheedgeofscience - let me just say that Canadians and Australians are allowed a 6 month visa free stay in the UK an i am sure that can be extended for up to 1 year if necessary, so there is no need to take boxes of medication with you back home, as I am sure there is a high risk of customs confiscation.

p.s. for some reason you don't seem to have a private message function attached to you.

 

I agree. I will try to update my "personal information" page with some more relevant information (and links). Having said that, I am a member just like everyone else here, and so I post with the same conditions and restrictions that apply to all other members (re your statement "fragmented"). Anyone can post here (provided they follow the "netiquette" of the forum). It is then up to the other members to decide which "pieces of information" (= posts) they want to pay attention to. I basically just share what I have to say; people can then choose to read it or not. The only thing that makes my posts slightly different (in my opinion) is that I have documented all of my treatments with Markku - so that members know I am not an Internet troll (or whatever it is called - I am getting too old for Internet slang... ).

Also, my opinion of treatments is not static - it is something that evolves. At this time last year, both AM101 and AUT00063 were insignificant spots on the radar (and they still are if you think about it - ie. both are in clinical trial; it's not a finished product yet). For that reason, I had no choice but to become my own doctor and come up with my own treatment plan for curing an incurable pathology.

To answer your question, these are the treatments I have attempted or been involved in:

1) Steroid infusion
2) LLLT
3) Stem cells (x 2): using guided stem cells and high dosage non-guided stem cells.
4) Flupirtine (currently doing this)
5) AM101 (I found a doctor at the highly competent ENT surgery clinic, Acquaklinik, who is involved in the AM101 clinical trial; he was willing to perform the procedure outside of the clinical trial provided I pay for the treatment and sign papers releasing him from responsibility, but Auris Medical would not release the drug for purposes outside of the clinical trial)
6) HIFU (I have an appointment with the professor Jeanmonod in November for a clinical evaluation using EEG scan; that's in Switzerland).

So it's been a bit of journey - quite literally. At this point, I have travelled more than 40,000 km for all of my combined treatments (that's a trip around the entire Earth...).

 

Try this: https://www.tinnitustalk.com/threads/my-introduction.1862/

 

There seems to be some confusion, so I'll clarify. I was wrong in thinking that dboy was referring to a clinical trial in the US, but I was not wrong that there is a plans to have a trial in the US. It's been on Autifony's website since slightly before the beginning of time:

http://autifony.com/autifony-pipeline.asp

What we don't know now is if the time frame of the trials will exactly correspond, and if they will have the same or different criteria. But there have been two trials in the works since phase II was announced: AU00063 vs tinnitus in the UK, AU00063 vs age related hearing loss (acuity) in the US. No need to book your tickets yet, Yanks.

I am really hoping the US trial will follow the criteria of the UK and have no additional requirements. Went to a wedding last night and I was practically deaf in the cloud of noise. The volume level never stepped down for me, which I think is a sure sign my auditory channels are depolarized and thus unable to regulate.

 

@attheedgeofscience

How does Dr.Large feel about aut00063, does he think this may be the cure?
What are your impressions?

 

I attempted to get hold of Mr. Large today (as promised). However, it turns out that his phone number is a closely guarded secret, apparently. His phone number was not part of his e-mail signature from the e-mail I exchanged with him the other day. And the Autifony homepage does not list any phone numbers either. The only phone number I was able to locate was the following: http://www.drugs.com/clinical_trial...-phase-study-lead-product-aut00063-15661.html (see bottom of the link). However, when I called the phone number shown, it turned out that the number is for their PR relations company. Initially the woman who answered my call was fairly helpful, but when I mentioned the clinical trial, she said that I had better discuss the details with Autifony directly; but she could - or would - not provide the phone number (saying she didn't have it - yeah, right!). She suggested therefore that I write another mail to Autifony. Which I have done midday today (local time here in Germany). In the e-mail I mentioned - as a "selling point" - that the information would benefit a lot of people (and not just myself), and hence cut down the workload that Autifony experiences in terms of e-mail requests. However, the workday is definitely now over in the UK, and I still have not heard back from Mr. Large. So maybe I will get a response later on, or maybe not. We shall see...

However, I must say - from a management point-of-view - if I were CEO of such a small company, I would invite myself to the various tinnitus forums and do an update once a month, or so. That would eliminate a lot of speculation, greatly reduce e-mail requests, and generally benefit the tinnitus community as well.

If I don't get a response, I can try to contact one of the clinical trial centres directly (Autifony is the sponsor, not the implementor of the clinical trial). I know the University of Nottingham is one such centre - I have details of a certain professor who works there. We shall see. It is not really worth it since we are so close to the clinical trial data information release, anyway. And I also feel I am sort of overstepping the boundary of good behaviour by doing so.