AM-101 Clinical Trial — Participants Updates and Discussion

university of michigan has some trial set up for next year I believe.

 

https://globenewswire.com/news-rele...unces-AAO-HNSF-Annual-Meeting-Activities.html

 

I will not do any comment but I am impatient to see the safety data they will present. I am still in a survival mode...I live in hell and borderline to suicidal mode.

 

TACTT2 Safety data results.

 

NOTHING works for this horrendous condition NOTHING, and nobody really cares , they don't want to find the cure because the hearing aid , TRT, CBT, and all the other craps business going down.

 

Hmm the mean age was 44. That's higher than I expected. That means a good amount of participants were in there 50's and 60's, at which point one has to wonder how much of their tinnitus is due to age related hearing loss. And the average hearing threshold was 27.4 to 28 db which is mild hearing loss; I thought hearing loss was exclusionary.

I'm very disappointed in AM101's results, but at least they are trying to fix this condition. Auris, decibel therapeutics and probably a few others are dedicated to fixing hearing ailments.

I do agree, I wish more money and focus was put into finding a cure or actual treatment rather than hearing aids and TRT.

 

@Alue Did you have a look on the adverse event ?

For treatment emergent adverse events (TEAE) on all participants:
AM101: 44,8%
Placebo: 34,1%

Does TACTT1 was showing such a high number of TEAE ?

 

That because the ears are already hit earlier.....also 3 sets of injections are damanging than 1 as they are repeatedly hit before they can heal.

 

But in TACCT1 it was three intratympanic injections of AM-101 (0.27 or 0.81 mg/ml).
The TEAE (column TR) was 30% for each AM101 groups.

 

How far do you think this sets back tinnitus cure? I know we people 10 years ago were thinking it would be solved by now. And people now thought it would be solved in 10 years. Honestly when do you guys think it will be?

If stem research takes off I have hope this goes exponentially. But if we keep doing the same archaic methods it will take forever.

 

Tinnitus will always be solved in 10 years, no matter when you ask the question... Whether it's now, in 1985 or in 2050... In 10 years we will solve it.

Kidding aside, contrary to ten years ago there are a lot of different parties involved now with solving hearing issues and Tinnitus. Even parties we never heard of before suddenly come out with selecting a compound and planning trials. It looks better than ever. I'd say that, while 10 years ago saying "it will be solved in 10 years" was largely positive self-talk (as no one was really working on it), this time we might just stand a chance to actually solve it in 10 years... I'm positive the 2020s might herald the good news of silence for a lot of us, but maybe I'm just an optimist...

 

In the 80's, scientists discovered that birds were able to regenerate their hearing. In 2015-2016, Novartis/Genvec started the first hair cells regeneration human trial.

It's not fast, but it's not so slow. And things are going way faster now, thanks to technology.

 

Eventually this prediction has to become reality.
It is like predicting the weather. If you keep predicting rain, you have to be correct eventually.
But I like to be positive too. Just look at investments.

 

Nobody has a glass bowl and or is able to predict the future but with current developments.
15 yrs is nothing in medical science. Not even textbooks in medical school are rewritten in that time.
Some things became much smaller due to technology and we can print 3D bones right now, but as this is not a mechanical thing, it requires understanding how the brain works, and that is the time consuming factor. Maybe even much larger deceases will be solved first and the solving of T is just a by product, an accidental discovery.

Also, it does not mean it's a quick solution. We might have to take drugs for the rest of our lives to keep the noise away. With possible (long term) side effects, is that what we want?

If I see people here taking Trobalt to get rid of the T, but maybe develop other shit than it's a no go zone for me. I don't want to get rid of my T and destroy other healthy organs.

 

no! I have some friends and family that have put together an account. I have been reading about umbilical cord blood and Whartens jelly. Theres a chance to bring down the t. I also have all these auto-immune illnesses. The western world only has meds that make you more ill in time. Im going to the clinic where Gordy Howe and Bart Starr went.
They have to accept you. After 6 years of western medicine Im ready to roll the dice.

 

Life changing due to trials. Its worse than that. 50,000.000 acute and 25,000.000 tinnitus sufferers have virtually no real relief no real medication. Any one who takes western meds has the chance of getting worse. The gov. and the FDA are hideous.

 

So you're going to have stem cell injections ? Hope that'll work for you...

 

This powerpoint misses a lot:

-How did the patients feel about the injections
-How many patients felt relief (placebo relief is also relief)
-How many patients felt any pain
-What is planned next

To me, research has got to do something more with dorsair cochlear nucleus. How does this work, how is it connected, how does it react on T.

Secondary, which I saw in electroceuticals research on T is that what frequency does T give in the brain. They had a small graph that showed normal sound e.g. 400 hz which gave a distorted 600 hz sound in the brain. How did they measure that? If on mice, when will this be possible on humans?
If we understand the thing better, it's a more suitable choice than just throwing arrows on it and wait until one hits the bullseye. However, they tried in this research and it had some quite good researched material under it, so it was more than just a lucky shot. But unfortunately not the right one.

 

@Codaz yes you are right. Detailed information should be provided with the published results of TACTT3 in November.

In addition to that and if I understand well the presentation with my French English :

They consider that primary safety end point is reached at day 35 because there are slightly no difference between AM 101 group and placebo. However in accordance with the figures (Air conduction figure) ,there are more than 5% of participants (which may represent between 15 and 20 people) who had clinically Relevant Hearing Deterioration ! Am I right ? If I am right how can we speak about safety end point reached when you do not have 0%.

I would also highlight that there are 15% more TEAE in TACTT2 than in TACTT1 in the AM101 group.

Cheers.

 

Auris wrote on their communication page that they will present updated info on keyzilen on 10/11 so stay tuned for tomorrow news

 

http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2210649

 

From today's press release: "New knowledge gained from the TACTT2 trial allows us to make appropriate adjustments to the TACTT3 trial while we are still fully blinded to its outcomes. We believe that the measures outlined today will improve the probability of success"

What exactly does that mean? They aren't changing the drug so instead they are changing their definition of success? Don't get me wrong I want this drug to work but that doesn't seem the way to go about fixing it if it doesn't.

 

So they will recruit again in 2017.

 

So there was a conference call hosted by Auris Medical which I attended today at 14:00 o'clock (European time).

I don't have the slides in front of me - and - I do not know if they will be released, so the following is from memory (and may not be 100% accurate, therefore):

• Two subgroups within the study population have been identified for which efficacy of AM-101 was demonstrated: those suffering from otitis media (16%) and those suffering from severe tinnitus (30%).
• The overall subgroup constituting of traumatic injury (i.e. mainly/only noise induced, I believe), and which accounts for 84% of the participants in the trial, did not show a statistically meaningful difference (vs. placebo).
• 120 extra patients will be enrolled in the European trial (i.e. 60 patients allocated to stratum A + B, respectively). This is the reason for the extension of the timeline of "early 2018" before final results will be available (due regulatory paperwork + execution of the trial itself).
• High degree of variability in terms of patients experiencing positive outcomes was seen depending on the treatment centres.
• The TFI-score showed a better improvement than the TLQ score (tinnitus loudness questionnaire). It is believed - based on physician feedback - that, a daily rating of tinnitus loudness over an 84-day period made an improvement difficult to establish for patients.

The 120 extra patients will increase the statistical power of the clinical trial in order to prove/disprove efficacy (hopefully the former).

 

Thousands of studies are underway for tinnitus and hearing loss relief. AM-101 is just one that is in the clinical trial phase. Many more will come soon enough. Don't let the results get you down from the 101 trials.

Here is an interesting article I have shared a few times. Hoping this team of researchers can unravel the mysteries of Wnt and Kremen 1. Be nice to see this make it to the clinical stage soon..........

http://hearinghealthfoundation.org/blog?blogid=251

 

...And which has absolutely nothing to do with AM-101. The Kremen1-study (along with the Stanford work by the Heller-lab) actually highlights that, to grow the inner ear cochlea in a lab, is more difficult than previously believed.

Just so you know...

 

Totally agree, however they are not trying to grow a new cochlea in a lab or your head. This study works on the healthy supporting cells we already have and asks them to multiply and create more hair cell bundles..... so yea know.

 

Attached is the presentation...

 

Statements like this are absurd. This isn't how capitalism works. The people who make the breakthrough of solving tinnitus will be rich beyond their wildest dreams.

The reading glasses industry wasn't able to suppress lasik surgery. Don't be an idiot.

 

Having been in the study. I really wish they had asked more questions in attempt to distinguish the possible sub-types of tinnitus. Like 'where do you perceive your tinnitus: in your head, in your ears, or both?' and 'do you ever get fleeting (occasional) tinnitus on top of your normal tinnitus?'.