AM-101 TACTT1 Results Released

[Johno]

Hi guys,

i'm just back home from my first injection. I wasn't even nervous before as i kind of completely forgot the appointment... long story short, i managed to get it around 2PM.

I have to say i thought the injection was gonna be the "big thing", it appears the anaestesia was the "strange" part. The gel in the ear feels a little "weird", i have to say, when it is injected and hurts just a little bit. When they suck it out, it doesnt hurt and sounds like a storm but not "very loud" like someone said before in this thead... Well we all are different

Then the injection was completely painless, i felt absolutely nothing when the poke the eardrum. The product is painless too.

Now my ear feels just a little full but it can be the same feeling you have in the morning when you ears start to wake up...

I'm going back tomorrow and on wednesday for the last injection.

You have T nearly one year, it means your participation is most interesting for me - it shows if Am101 is usefull for chronic sufferers. I believe yes.

 

[dgn58]

Please tell us more. When should you see the outcome, on weather or not it is working. Costs, how many injections are required. Are they doing this in the US.

Or is this a clinical trial in your country. How long have you had tinnitus / Thanks for the info.

 

[James White]

Please tell us more. When should you see the outcome, on weather or not it is working. Costs, how many injections are required. Are they doing this in the US.

Or is this a clinical trial in your country. How long have you had tinnitus / Thanks for the info.

it should take a few weeks to see any results. They are doing the trial in the US too : http://tinnitus-study.info/

you have 60% chance of having the product, the other one is a placebo. you need to have tinnitus for under 12 months for this study

 

[Littlebailey]

I contacted the phone number for the US trial. When I called I was borderline 3 months T. They said they would contact me once the trial begins. Since it's been a month and no contact, I'm guessing I was disqualified due to being over 3 months. I had thought they allowed for people with longer than 3 months though?

What's the phone # for the US trials?

 

[Champ]

Hi guys,

i'm just back home from my first injection. I wasn't even nervous before as i kind of completely forgot the appointment... long story short, i managed to get it around 2PM.

I have to say i thought the injection was gonna be the "big thing", it appears the anaestesia was the "strange" part. The gel in the ear feels a little "weird", i have to say, when it is injected and hurts just a little bit. When they suck it out, it doesnt hurt and sounds like a storm but not "very loud" like someone said before in this thead... Well we all are different

Then the injection was completely painless, i felt absolutely nothing when the poke the eardrum. The product is painless too.

Now my ear feels just a little full but it can be the same feeling you have in the morning when you ears start to wake up...

I'm going back tomorrow and on wednesday for the last injection.

I heard it takes a bit to work, like a couple weeks sometimes.

This sounds very interesting =) I want it to work for you, for selfish reasons James!

On a related note, I got a message from a woman running the NYC trials.

The sponsor is planning an open label study but only for participants of randomized trial for now.

That means that they're going to just give everyone who didn't get AM-101 in the trial the AM-101 injection, if they want it. That means everyone who had the placebo will have the option of coming back and taking it. That sounds like a damn good sign to me if you ask me.

 

[benryu]

[What's bellow is just my OWN interpretation, I am not a Doctor nor an ENT specialist, just a guy who had T. for 5 years and read a lot of stuff about T. ]
In my view, AM-101 is very likely to work on chronic T. too, or at least greatly help. It's advertised to be designed for inner ear acute Tinnitus. Reading doctor Hamann Martine's work T. is the expression in your brain of a malfunction of ear cells in your inner ear. It results in potassium channels in your brain being disrupted.

In other word, we all have a noise switch in the brain that is suppose to automatically turn OFF when there is no noise. As you're inner is sending a corrupted signal the switch remains activated and stays stuck on the ON position.
AM-101 is helping to stop this inner ear corrupted signal and help your brain to regulate potassium channels. (Or to put it simply, learn again how to turn OFF the noise switch in your brain).

The cool stuff with T. is that this is not an evolutive problem, it's a state. Despite natural aging, it's actually impossible to tell the difference between a T. that occured last month, last year, or last decade.

So most likely, after a longer period the brain will just struggle more to rehabilitate, but like for most rehabilitation it just means that it needs more time, not that is impossible.

Last but not least, I believe the AM-101 will work very well in combination with the AUT3 for chronic tinnitus.
AM-101 will do most of the job, but the remaining may be traited on a longer period with the AUT3 that seems to be disease-modifying drug.

I am very excited about all these trials and I can't help thinking that the cure is nearer than we think!

 

[dan]

I don't think AM101 will work for chronic tinnitus.
The ear isn't sending a corrupt signal. The brain is sending a corrupt signal. Why do we have totally deaf people without an inkling of tinnitus?
What does AM101 do? I thought it inhibited noise induced Glutamate toxicity which causes hair cell death.
Once the hair cells die AM101 can't bring them back to life. The brain has already locked in to the missing frequencies and corrupts potassium channels-
Autifony has a good shot and its my last hope-it may be the brain switch you were talking about. .
I hope AM101 works for you guys here, but I'm not seeing profound results.

In a key breakthrough in collaboration with GSK who sponsored Dr Pilati's PhD, the team also discovered the specific cellular mechanism that leads to the neurons' over-activity. Malfunctions in specific potassium channels that help regulate the nerve cell's electrical activity mean the neurons cannot return to an equilibrium resting state.
Ordinarily, these cells only fire regularly and therefore regularly return to a rest state. However, if the potassium channels are not working properly, the cells cannot return to a rest state and instead fire continuously in random bursts, creating the sensation of constant noise when none exists.
Dr Hamann explained: "In normal conditions the channel helps to drag down the cellular electrical activity to its resting state and this allows the cell to function with a regular pattern. After exposure to loud sound, the channel is functioning less and therefore the cell is constantly active, being unable to reach its resting state and displaying those irregular bursts."
Although many researchers have investigated the mechanisms underlying tinnitus, this is the first time that cellular bursting activity has been characterised and linked to specific potassium channels. Identifying the potassium channels involved in the early stages of tinnitus opens up new possibilities for preventing tinnitus with early drug treatments.
http://www2.le.ac.uk/offices/press/...lular-mechanisms-behind-the-onset-of-tinnitus

 

[benryu]

I don't think AM101 will work for chronic tinnitus.
The ear isn't sending a corrupt signal. The brain is sending a corrupt signal. Why do we have totally deaf people without an inkling of tinnitus?
What does AM101 do? I thought it inhibited noise induced Glutamate toxicity which causes hair cell death.
Once the hair cells die AM101 can't bring them back to life. The brain has already locked in to the missing frequencies and corrupts potassium channels-
Autifony has a good shot and its my last hope-it may be the brain switch you were talking about. .
I hope AM101 works for you guys here, but I'm not seeing profound results.

In a key breakthrough in collaboration with GSK who sponsored Dr Pilati's PhD, the team also discovered the specific cellular mechanism that leads to the neurons' over-activity. Malfunctions in specific potassium channels that help regulate the nerve cell's electrical activity mean the neurons cannot return to an equilibrium resting state.
Ordinarily, these cells only fire regularly and therefore regularly return to a rest state. However, if the potassium channels are not working properly, the cells cannot return to a rest state and instead fire continuously in random bursts, creating the sensation of constant noise when none exists.
Dr Hamann explained: "In normal conditions the channel helps to drag down the cellular electrical activity to its resting state and this allows the cell to function with a regular pattern. After exposure to loud sound, the channel is functioning less and therefore the cell is constantly active, being unable to reach its resting state and displaying those irregular bursts."
Although many researchers have investigated the mechanisms underlying tinnitus, this is the first time that cellular bursting activity has been characterised and linked to specific potassium channels. Identifying the potassium channels involved in the early stages of tinnitus opens up new possibilities for preventing tinnitus with early drug treatments.
http://www2.le.ac.uk/offices/press/...lular-mechanisms-behind-the-onset-of-tinnitus

Thanks for your reply, it's very interesting, and I certainly agree that AM 101 is not reviving hair cell. We are not talking about stem cell therapy.
But now when reading Auris medical comments about the AM 101 (http://www.aurismedical.com/p/therapies/am_101.php) I see three things:
1 - It's actually blocking unwanted signal between inner ear & brain.
2 - It's designed for acute Tinnitus, and they have no idea how long after the acoustic trauma it may work. They will probably do further testings. They are just being very safe in what they say.
3- Acute vs Chronic will be most likely about brain plasticity, and we know little about it.

I am still optimistic about the AM 101, I think it might not be as effective for acute tinnitus than for older tinnitus, but could potentially have a positive effect on chronic tinnitus for some people.
It seems that some patients in this trial had T. for more than 12months, let's see how they do

 

[dan]

Ok lets see, we had a NMDA drug trial for tinnitus called Neramexane. It failed miserably, despite going on to phase 3 open trials.
http://www.merz.com/research_and_development/neramexane_tinnitus/neramexane/
I realize that Neramexane is an oral treatment, but it had absolutely no beneficial effect on tinnitus vs placebo. I would think that some NMDA would reach the inner ear orally?

 

[benryu]

Ok lets see, we had a NMDA drug trial for tinnitus called Neramexane. It failed miserably, despite going on to phase 3 open trials.
http://www.merz.com/research_and_development/neramexane_tinnitus/neramexane/
I realize that Neramexane is an oral treatment, but it had absolutely no beneficial effect on tinnitus vs placebo. I would think that some NMDA would reach the inner ear orally?

I suppose it should be more effecient, but the molecule is most likely not the same. Otherwise Merz would have (or will) sue the shit out of auris. Like you do, I have more hope in the AUT63, especially for the reason I discussed in the dedicated thread with some other members, but AM 101 could be a first step and even a slight relief would be gladly accepted by most of us. The trial is more advanced for AM 101 than for AUT63, so we may try this one first

By the way, last but not least, Auris got $51M funding to push the AM 101 (http://www.bioworld.com/content/auris-medical-gets-51m-hearing-disorder-drugs-1), the AUT63 is also getting a shit load of money, and to me it's a very, very good sign. Just to give you an idea, the cumulated money those two companies got for pushing those cures, is almost equivalent to all the money spent for T. during the last decades.

 

[attheedgeofscience]

As most people who have followed my stem cell treatment will know, I have a fairly extensive network of contacts in the medical business. Through my contacts, I have managed to track down a doctor who will administer the drug ketamine to my middle/inner ear. The procedure I will be getting is not part of the ongoing AM101 clinical trial, but it is equivalent to it. For that reason I can report back at some point in the future on the effectiveness of the treatment - and I will be able to do so with confidence as I will of course be 100% certain of not getting the placebo (but unlike the participants in the clinical trial, I will also have to pay for the treatment of course).

I will need to sign papers that I am taking the risk for treatment. The procedure is almost certain to go ahead, and will take place probably in May. There are still a few details to work out - possibly mixing the injections with cortisone, but we will get there eventually, I am sure. As with my stem cell treatments, I obviously cannot disclose where I am getting this done. But, I can at least provide feedback on the effectiveness of the drug - which I will do.

Guys, I am really sorry, but the planned AM101 injections (both ears, off label) will not go ahead. The doctor I had seen about the procedure had promised more than he could deliver. Auris Medical will not release the drug for off label purposes. The clinic was in Germany. Following that, I went through a lot of "red tape", and also enlisted the help of my Father - who lives in Switzerland - in order to get Auris Medical to change their mind. No success.

I had actually not planned to return to tinnitustalk, but when the above opportunity suddenly presented itself, I felt it made sense to add my input to this thread. As someone who has had tinnitus since childhood, it would have been a unique opportunity to test whether the drug could possibly influence "chronic tinnitus". But, as is often the case in experimental medicine, things don't always go according to plan. In fact, I spend most of my time travelling, studying, networking, corresponding, dealing with bureaucracy, and "spending money" - rather than "doing actual medicine".

The only other thing on my radar at the moment is a planned visit for a clinical evaluation at the advanced non-invasive neurosurgery clinic in Switzerland (HIFU). The surgery is unique. The visit is not until some time later this year. It should be interesting. Here is a link that discusses it:

https://www.tinnitustalk.com/thread...used-ultrasound-surgery.276/page-6#post-42580

As with my stem cell treatments, I have documented to @Markku in a PM the steps I have taken in regard to the above medical procedures (AM101 off-label + HIFU) in order to prove that this is/was real (and not just an Internet Troll "playing games" with the TT-community). The professor of HIFU surgery has asked me to do everything I can before opting for surgery. I will therefore be getting a second round of LLLT therapy. If there is any benefit I will report about it.

Since my next move in the world of experimental medicine is some way off, I will be leaving this community again.

Lastly, it has come to my attention via "other channels" that the Henry Ford Medical Group in the US are planning a second round of AM101 trials - and are hoping to get approval for it in the very near future. It is unclear to me whether they are also seeking off-label approval of AM101. But I know this much: if off-label approval is granted or if the patient can get the drug some other way, then the doctors there are willing to perform the procedure as in the clinical trial (provided the patient pays him-/her-self). So it might be worthwhile for some of you to follow up on this lead (if you like me, are willing to make an extra effort). This is dependable information.

And remember:

"Adventure is worthwhile in itself"
--Amelia Earhart, Female Aviator & Pioneer

Take care.

 

[cullenbohannon]

Hope to see you back here soon. Goodluck!

Guys, I am really sorry, but the planned AM101 injections (both ears, off label) will not go ahead. The doctor I had seen about the procedure had promised more than he could deliver. Auris Medical will not release the drug for off label purposes. The clinic was in Germany. Following that, I went through a lot of "red tape", and also enlisted the help of my Father - who lives in Switzerland - in order to get Auris Medical to change their mind. No success.

I had actually not planned to return to tinnitustalk, but when the above opportunity suddenly presented itself, I felt it made sense to add my input to this thread. As someone who has had tinnitus since childhood, it would have been a unique opportunity to test whether the drug could possibly influence "chronic tinnitus". But, as is often the case in experimental medicine, things don't always go according to plan. In fact, I spend most of my time travelling, studying, networking, corresponding, dealing with bureaucracy, and "spending money" - rather than "doing actual medicine".

The only other thing on my radar at the moment is a planned visit for a clinical evaluation at the advanced non-invasive neurosurgery clinic in Switzerland (HIFU). The surgery is unique. The visit is not until some time later this year. It should be interesting. Here is a link that discusses it:

https://www.tinnitustalk.com/thread...used-ultrasound-surgery.276/page-6#post-42580

As with my stem cell treatments, I have documented to @Markku in a PM the steps I have taken in regard to the above medical procedures (AM101 off-label + HIFU) in order to prove that this is/was real (and not just an Internet Troll "playing games" with the TT-community). The professor of HIFU surgery has asked me to do everything I can before opting for surgery. I will therefore be getting a second round of LLLT therapy. If there is any benefit I will report about it.

Since my next move in the world of experimental medicine is some way off, I will be leaving this community again.

Lastly, it has come to my attention via "other channels" that the Henry Ford Medical Group in the US are planning a second round of AM101 trials - and are hoping to get approval for it in the very near future. It is unclear to me whether they are also seeking off-label approval of AM101. But I know this much: if off-label approval is granted or if the patient can get the drug some other way, then the doctors there are willing to perform the procedure as in the clinical trial (provided the patient pays him-/her-self). So it might be worthwhile for some of you to follow up on this lead (if you like me, are willing to make an extra effort). This is dependable information.

And remember:

"Adventure is worthwhile in itself"
--Amelia Earhart, Female Aviator & Pioneer

Take care.

 

[cullenbohannon]

NINE DAYS
. The numbness and fullness have decreased a great deal. T is almost back at baseline not very bothersome at this point.

 

[erik]

@cullenbohannon --Thanks for the continued updates and good luck.

 

[LondonGirl]

Guys, I am really sorry, but the planned AM101 injections (both ears, off label) will not go ahead. The doctor I had seen about the procedure had promised more than he could deliver. Auris Medical will not release the drug for off label purposes. The clinic was in Germany. Following that, I went through a lot of "red tape", and also enlisted the help of my Father - who lives in Switzerland - in order to get Auris Medical to change their mind. No success.

I had actually not planned to return to tinnitustalk, but when the above opportunity suddenly presented itself, I felt it made sense to add my input to this thread. As someone who has had tinnitus since childhood, it would have been a unique opportunity to test whether the drug could possibly influence "chronic tinnitus". But, as is often the case in experimental medicine, things don't always go according to plan. In fact, I spend most of my time travelling, studying, networking, corresponding, dealing with bureaucracy, and "spending money" - rather than "doing actual medicine".

The only other thing on my radar at the moment is a planned visit for a clinical evaluation at the advanced non-invasive neurosurgery clinic in Switzerland (HIFU). The surgery is unique. The visit is not until some time later this year. It should be interesting. Here is a link that discusses it:

https://www.tinnitustalk.com/thread...used-ultrasound-surgery.276/page-6#post-42580

As with my stem cell treatments, I have documented to @Markku in a PM the steps I have taken in regard to the above medical procedures (AM101 off-label + HIFU) in order to prove that this is/was real (and not just an Internet Troll "playing games" with the TT-community). The professor of HIFU surgery has asked me to do everything I can before opting for surgery. I will therefore be getting a second round of LLLT therapy. If there is any benefit I will report about it.

Since my next move in the world of experimental medicine is some way off, I will be leaving this community again.

Lastly, it has come to my attention via "other channels" that the Henry Ford Medical Group in the US are planning a second round of AM101 trials - and are hoping to get approval for it in the very near future. It is unclear to me whether they are also seeking off-label approval of AM101. But I know this much: if off-label approval is granted or if the patient can get the drug some other way, then the doctors there are willing to perform the procedure as in the clinical trial (provided the patient pays him-/her-self). So it might be worthwhile for some of you to follow up on this lead (if you like me, are willing to make an extra effort). This is dependable information.

And remember:

"Adventure is worthwhile in itself"
--Amelia Earhart, Female Aviator & Pioneer

Take care.

Dear ATEOS
Wishing you all the very best and thank you for your generosity of spirit in sharing your forays into new - and sometimes risky - endeavours.
May he who dares win.
LG

 

[Littlebailey]

NINE DAYS
. The numbness and fullness have decreased a great deal. T is almost back at baseline not very bothersome at this point.

Hey, do you mind if I ask what your ENT doctor said about your case? I don't mean to be too personal, and you don't have to go into it if you don't want, but if you got yours from an ear infection, did he tell you that it might pass away when the infection clears? Did you get antibiotics or some specific treatment to beat the infection? I'm curious because you had said you finally found a very solid doctor, and so many ENTs seem so clueless of indifferent. Again, don't mean to pry, just rather curious. Thanks.

And good news on your progress so far with the trial!

 

[cullenbohannon]

Hey man no problem. I was given antibiotics and ear drops he said he's had patients who had it disappear 6 months later or years later. If it is just from fluid in the ears it could go when the fluid is gone in my case the damage was already done. By the time I got to the ent I liked the infection had cleared already.

Hey, do you mind if I ask what your ENT doctor said about your case? I don't mean to be too personal, and you don't have to go into it if you don't want, but if you got yours from an ear infection, did he tell you that it might pass away when the infection clears? Did you get antibiotics or some specific treatment to beat the infection? I'm curious because you had said you finally found a very solid doctor, and so many ENTs seem so clueless of indifferent. Again, don't mean to pry, just rather curious. Thanks.

And good news on your progress so far with the trial!

 

[Mastov]

What's the phone # for the US trials?

It doesn't work that way. They have locations all over the US. You first send an email and then they provide you a number to the closest facility. The email to write to is auris-trials@medpace.com

 

[dgn58]

Thank you for the update

 

[James White]

Had 2nd injection yesterday and last one a couple of hours ago... Last injection didn't hurt but was a little more painful than the others.

Had the last two injections without anesthetics and i guess that was the best choice, because i think the anaestesia is more painful than the eardrum poking. Last injection was a little painful because the earcanal is now full of this sticky stuff. The needle is painless, it's more the gel that is a bit uncomfortable i'd say. same as @cullenbohannon ...

@Champ for the part where you can have the real deal after the 1st phase, the trick is that when they ask if you want the 2nd injection, you still don't know if you had placebo or not !!! hehe

 

[Littlebailey]

It doesn't work that way. They have locations all over the US. You first send an email and then they provide you a number to the closest facility. The email to write to is auris-trials@medpace.com

Thanks.

 

[cullenbohannon]

Good luck James. Has your hearing been affected at all?

Had 2nd injection yesterday and last one a couple of hours ago... Last injection didn't hurt but was a little more painful than the others.

Had the last two injections without anesthetics and i guess that was the best choice, because i think the anaestesia is more painful than the eardrum poking. Last injection was a little painful because the earcanal is now full of this sticky stuff. The needle is painless, it's more the gel that is a bit uncomfortable i'd say. same as @cullenbohannon ...

@Champ for the part where you can have the real deal after the 1st phase, the trick is that when they ask if you want the 2nd injection, you still don't know if you had placebo or not !!! hehe

 

[Penelope33]

Had 2nd injection yesterday and last one a couple of hours ago... Last injection didn't hurt but was a little more painful than the others.

Had the last two injections without anesthetics and i guess that was the best choice, because i think the anaestesia is more painful than the eardrum poking. Last injection was a little painful because the earcanal is now full of this sticky stuff. The needle is painless, it's more the gel that is a bit uncomfortable i'd say. same as @cullenbohannon ...

@Champ for the part where you can have the real deal after the 1st phase, the trick is that when they ask if you want the 2nd injection, you still don't know if you had placebo or not !!! hehe

Do you still hear tinnitus right now?!

 

[rtwombly]

I apologize if these questions are answered in the previous pages, but I had initially written off AM-101 as not applicable to me, as I'm unsure the source of my tinnitus. Now I'm trying to re-evaluate. Can somebody give me the quick-and-dirty answers to these two questions?

1) Is AM-101 intended to be delivered on a repeated basis, provided it proves effective for a patient? In other words, if one injection or a course of injections proved effective for me, would I expect to go back for another injection/course 6 months down the line?

2) Have any of the Phase I/II participants reported on their experiences, as cullen and James are reporting on their Phase III?

 

[attheedgeofscience]

I apologize if these questions are answered in the previous pages, but I had initially written off AM-101 as not applicable to me, as I'm unsure the source of my tinnitus. Now I'm trying to re-evaluate. Can somebody give me the quick-and-dirty answers to these two questions?

1) Is AM-101 intended to be delivered on a repeated basis, provided it proves effective for a patient? In other words, if one injection or a course of injections proved effective for me, would I expect to go back for another injection/course 6 months down the line?

2) Have any of the Phase I/II participants reported on their experiences, as cullen and James are reporting on their Phase III?

1) It is intended as a one-off course of 3 injections delivered over a couple of days. It is not intended for a repeat session. Participants in the trial are, however, offered to get the real drug if they received the placebo during the trial. Not sure about the participants who received the real drug (there are two strength variants used in the clinical trial).

2) Member @urtica is a phase II participant, I believe.

 

[lapidus]

I apologize if these questions are answered in the previous pages, but I had initially written off AM-101 as not applicable to me, as I'm unsure the source of my tinnitus. Now I'm trying to re-evaluate. Can somebody give me the quick-and-dirty answers to these two questions?

1) Is AM-101 intended to be delivered on a repeated basis, provided it proves effective for a patient? In other words, if one injection or a course of injections proved effective for me, would I expect to go back for another injection/course 6 months down the line?

2) Have any of the Phase I/II participants reported on their experiences, as cullen and James are reporting on their Phase III?

Check this whole thread, it's worth it. There are stories from participants in here from earlier phases and some links to other forums with stories. Alll positive ones what I can recall.

 

[James White]

Good luck James. Has your hearing been affected at all?

can't hear sh*t in my left ear and ringing like crazy...

 

[Hudson]

can't hear sh*t in my left ear and ringing like crazy...

When did you receive the injections? Are you still getting them? The increase seems to be normal

 

[daedalus]

can't hear sh*t in my left ear and ringing like crazy...

In another account, the patient reported a temporary increase of tinnitus after his injection. The method of injection was different: anaesthesia, hole in the eardrum with a little scalpel, then injection.

 

[Penelope33]

Sorry to hear this. I was hoping you'd have great news to share. So it dosent work then :-(