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

Firstly, @mintblue welcome on board (unfortunaly we all came on board)
Anyway, your remarks absolutely make sense, however, what brings you then to TinnitusTalk?

For myself, i shouldn't be around this forum that much (slowers acceptance etc... for sure).

At the other hand it gave me much support, direction, hope for a future threatment and avoided me to do stupid thing (exposure to certain sounds which I would have considered safe but as well take/took away suicidal thoughts I never had before since the T onset!!!). it also makes me aware of potential threatment (AM 101) for me, since I'm a noise induced T victim through prolonged earbuds exposure (not the loudnest but the lengthy time did for sure his hellish job). Thus this is the contradication I face for myself the last few weeks since I'm active on this forum!?!

Should I stay or should I go!!!

Regarding below
The brain hasn't "learned" the sound by any means and that's been disputed several times over. The sound comes specifically from a dysfunction in your auditory system, most likely the neurons over-firing.

It is said that over time the sounds move from the ear to other parts of the brain and that it more or less get inprinted in the mind! You are telling that this isn't the case if I understand you correctly, right?

Do you have a paper or reference which supports your remark, since this is very interesting so to say.

I also read an interesting article about white noise which seems opposite to yours;
White noise The theory that tinnitus is created by the loss of inhibitory stimuli has resulted in the most promising new therapy for tinnitus so far: white noise therapy. White noise, such as that produced by a radio tuned to an empty frequency or a sound generator like a Marsona, has two effects: first, it masks the ringing sound; and second, it helps to stimulate the inhibitory pathways by producing a continuous background of sound. The extent to which these pathways can be rewired is still not entirely clear, but it is clear that white noise creates additional excitatory and inhibitory stimuli that appear to be able to influence the synaptic regrowth in the DCN, and prevent tinnitus from starting. (They are also great for preventing insanity caused by having a neighbor who is overly fond of rock music.)

According to the theory described above, noise-induced hearing loss produces tinnitus because it is, in effect, creating silence. Indeed, most normal people will experience tinnitus when placed in an anechoic chamber. Therefore, one could logically expect background noise to prevent it. However, this is difficult to prove, because noise also masks tinnitus.

Nevertheless, it is true--at least in animals. Noreña and Eggermont have found that if white or blue noise (5kHz-20kHz) is presented immediately after noise trauma and maintained over a period of several weeks, the neuronal changes that cause tinnitus and hearing loss are abolished [9, 10]. This remarkable finding shows that it may be possible to prevent noise-induced tinnitus even in cases of acoustic trauma.

It goes without saying that white noise, or any other noise, above 85 decibels will cause hearing loss, especially if maintained for long periods of time. Moreover, there is some suggestion that white noise could be harmful for infants. Also, it stands to reason that sound therapy, or any other therapy, will not work unless whatever caused the tinnitus in the first place is stopped.

The theory would predict that for a maximal effect, a sound generator would have to be running continuously, not just when the patient's ears are ringing. Also, the closer the frequency of the generated sound to the frequency of the tinnitus, the more effective it should be.

For more info see
Tinnitus: Causes and Treatment

 

There was a famous case of tinnitus gone after 40 years due to a stroke....so I don't see why it should be imprinted in the brain.

 

Imprinted is maybe too strong but I do not have another word for it.
From what I've read over time the brains get used to the sound and other parts of the brain getting involved and due to this it is harder (or maybe impossible) to remove the phantom sounds.

 

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I found the article in which the stroke case is mentioned
The Brain: "Ringing in the Ears" Actually Goes Much Deeper Than That | DiscoverMagazine.com
Plus it also describes what I tried to say .

 

Would be pretty great if someone with Tinnitus sneaked into the study - I know at this point they want only healthy people to test the safety, but still would be great if we already knew that the drug helps

 

Hey @Meestijn thanks for offering that information. I don't have any papers to back my claim. I'm like you, overexposure to sound through headphones, concerts, living in a busy city, etc. I saw my ENT several times to discuss the tinnitus and my hearing. He conducted tests all the way up to 20,000 hz where I heard at -15db, meaning I actually had more hearing at that level than the average human. The only significant dip in hearing was at 18,000 hz in the right ear (20db), where I do not have tinnitus. Even then, he noted that none of my hearing loss is enough to cause tinnitus. That's not to say stop listening to or working on music, he encouraged me to go back to concerts with musician's earplugs because they offer superior protection to foam plugs. Said studio work was safe so long as I took regular breaks and kept a cap on the time with louder volumes. He's confident my tinnitus will leave me within 2 or 3 years and I believe him.

The reason I come back here is because I've become interested in the whole topic and really do hope we find some relief for people soon. A fellow DJ friend of mine has so much hearing loss he cannot hear above 3,000 hz and says the tinnitus is as loud as a concert at all times in his head. I'm grateful that's not me but god damn do I want there to be a cure for him. I'm really confident AM-101 is going to be a breakthrough along with VNS for many people. In the unlikely case that my tinnitus does not resolve itself, it's nice to know that we're close to something that can potentially help

 

They probably just did up to 8,000 hz. The truth is any test above that is inaccurate and they only did it for me because they wanted to determine whether or not my tinnitus was caused with some certainty by higher frequency hearing loss. Turns out it's just stress and my hearing threshold being pushed a few times too many. Yours is probably similar, give it time man

 

Does this drug have a good chance of making it out to the market? I know that many trial drugs don't make it to the market after trials. I am afraid of this happening to this drug, which may help us all.

 

I hate to be a dick, but they really need to get the fuck on the ball with research.

 

We're not really taken serious. I mean, when you say we suffer from ringing in the ear, people kind of just roll their eyes at us and bring up cancer.

 

I'm in a doctors office right now. Ears are pounding away. Tubes in both ears for Eustachian Tube Dysfunction. And of course I am allergic to penicillin and cephalosporins so I am given tobramicin and cipro for ear infection. Both of which make ringing appear worse while on them. Not to mention having tubes in your ear temporarily reduces your auditory function. So needless to say, loud as fuck ringing and diminished hearing. I honestly don't understand how something so destructive and so common isn't understood.

 

I relate it to people in a simple way. Everyone feels sorry for you if you lose a limb because they can see the damage and the pain. They can't experience our mental torture so they play it off as nothing real. When to us it is stark reality and often ruins daily life. I've become an alcoholic basically due to this.

 

Apparently, the tube in my right ear fell out. Tubes have only been in four weeks. Hooray, more doctor appointments.

 

It is good to see that someone actually cares to resolve chronic cases.

 

http://static4.londonhearingaids.co...tion=com_easyblog&view=entry&id=22&Itemid=172

 

Greetings all,
As a fellow sufferer, I've been lurking this site for some time now, but never felt the need to respond until now. After reviewing the clinical research and speaking to Dr. Large himself, I'm very optimistic AUT will benefit those of us with chronic, noised induced T greatly. I'm also surprised that Autifony is still flying so far under the radar of T sufferers, as their work is quite revolutionary in comparison to the other research/trials out there, except for AM101 perhaps. Keep the faith everyone, the code to T is being cracked. Like someone earlier stated, "it's now not a matter of if, but when".

 

Do you have a link to some uplifting report or statements from the guys who work there?

 

This is nothing that hasn't been posted, but it's a pretty positive synopsis that may deserve a repost.

http://www.autifonytherapeutics.com/publications/Turneretal2013-TRI_final.pdf

As far as written documentation of my discussions with Dr. Large, I have none. Further, how uplifting any conversation is, would be subjective...what I find uplifting, someone else may take with skepticism and disbelief. The reality of the situation is AUT may not work in humans, that remains to be seen in phase II. However, there is a much greater understanding now of the neurological aspects of T, where the research is now being focused. This is a departure from the cochlear studies to date, and a scientific breakthrough. Once one understands the true architecture of a problem, solutions are often soon to follow. The team at Autifony and the financial backers behind them are enthusiastic about AUT, and as such, I can't help but to be enthusiastic and optimistic as well.

 

Are you taking part in the safety study at UCL in London, or how did you get in contact with this researcher?

 

No, being that I have chronic T, I wouldn't qualify. I did volunteer for phase II however, but I don't believe I'll be accepted...I live in the US, so it would take a lot of travel (which I'm willing to do), but you never know? It took some digging, but I was able to attain a phone number and a couple of email addresses. I have no doubt anyone on this site would be able to find the same info with some digging.

I really feel Autifony is on the cusp of something with AUT. It reminds of being younger and suffering with fairly severe heartburn. My doctor at the time really could not do much about it, other than suggest Rolaids, Pepto, or drink a glass of water and baking soda. Then the talk of acid blocker research began, after a breakthrough in understanding acid channels (or something to that extent). Fast forward a few short years, and a pill a day has kept me heartburn free for a over decade now. Life changer!!

We are fortunate to live in period of vast scientific advancement, as well as a time where T is more understood and financially backed.

 

For the record, my intention is not give anyone false hope. I suffer from debilitating T, so I understand the
insensibility of such.

 

swc5150 , can you clarify the reason why you would not be accepted to a phase II trial ?

I was under impression they are targeting chronic hearing loss/tinnitus.

 

A UK based trial will more than likely choose local sufferers.

 

Here is a link to the kv3.3 potassium channel modulator patent for tinnitus and other diseases.
Note the name Charles Large and Autifony.

http://www.sumobrain.com/patents/wi...nt-diseases-where-modulator/WO2013182851.html

 

I'm a science guy and those IUPAC chemical names scare the hell of out of me haha

 

Is AUT00063 also going to be given in an intratympanic injection like AM101? I haven't come across where it is directly stated.

 

I think it's a variation of a antiepileptic drug so my guess would be oral

 

Yep, looks like you are right. I re-read the link Hudson posted on page 1 and they said

Source:
http://www.autifony.com/publications/Autifony_AUT00063_FIH_Start__Fundraising_FINAL_03Jun2013.pdf

 

I think that this is going to be a HUGE breakthrough. Out of all of the treatments that are now coming into play, I have the most faith in this one. The fact that this treatment eliminated CHRONIC tinnitus in rats should give us all hope. We just need to stay strong and hang in there just a little longer!

 

AM101 in three years, 50% reduction

Then wait another 5 years, and get this.

I will be 27. Not bad to get a "second chance" as a 27 year old.

This is a best case scenario though.