Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

@dan thank you. Reading that does bring down my hope of am-101 working for me. But maybe it will help since I recently had a spike

 

Well, if we are a bit selfish, it is better that AM 101 and OTO works just days or maximum a month after acoustic trauma. We have to think about us and researches for chronic t.
Personally I someone offer me:
1.option- a cure today, but just for me and to anyone else,
or
2. option - cure for all but to wait 5 more years. I would accept second offer. I am honest as man can be.

Because I see how many people suffer with this, so i think it is not selfish to have a wish that AM and OTO works short time after injury.

 

There will always be a market for chronic T. Firstly of all the people that suffer from T today the vast majority are those who have chronic T. That means that there is literately hundreds of millions of us in the world.

Secondly if they manage to cure acute T. They won't be 100% successful. There will always be those who are not going to be helped. Then there are those who just won't get the drug on time and will then fall into the chronic category.

 

I wish so much that u are right. But I am afraid that we will be marginalized.

If acute t (up to 3 months) is gonna be cured, every year there will be millions t suffers less every year, as we dying and new generations that just got t will be cured (most of them). It means after 40-50 years form now, t will almost not exist while all chronic t suffers are gonna be biological dead unitl that time.

 

If you are thinking 40-50 years from now I can just say to you that the medical field will surly have a cure for T. in 50 years! I think that we will be able to heal the human body in completely new ways in that time. Nano technology is going to revolutionize the medical field. We are far from there yet but in 40-50 years we will be there for sure.

Also if the cure isn't here in 50 years from now there is no point in having one at all. At least not for me. I will be well in my 80's by then (if I'm still alive). And if I've managed to live with this thing for those 50 years I think I'll manage to live with it for the couple of ones that are left for me by then.

And once again. The "cure" for acute T. will surly not work for everyone and if the rest of the world continues to develop continents like Africa will be at least at the same level as we are now and will have the same kind of problems = lots of people with T.

Just relax. The cure is comming!

 

Our future and survival rides on Autifony right now.
If they succeed, even partially, and the drug gets approved, other companies and Autifony itself will try to improve the drug (if needed).
If they fail, it will be a huge setback and if the acute treatments succeeds, then I think companies will
scap any attempts to cure chronics! Our fates will be sealed in 2016.

 

It certainty will not! You forget that there are researchers that are chronics as well. It was one of the reasons for me to start studying molecular biology once. Stop being so damn negative!

What has been done in the past 10 years is truly amazing. When I first got this more then 9 years ago now, there was absolutely nothing! No hope! Nothing!

Curing acute stages are always the first in all ailments. We have learned so much and come so far just in the last few years. A cure is close! It's coming!

 

@dan don't forget about sf0034. It is behind Aut by a few years but it still has a chance at being effective.

 

This is mentioned in all texts: SF0034 is a clinical candidate for treating epilepsy and preventing tinnitus.

-treating epilepsy but PREVENTING tinnitus? Only preventing NOT helping or curing? Acute or chronic?

 

Based on the current understanding of how potassium channels are involved in the physiopathology of T, it seems it would be very beneficial if channel function is restored before plastic changes occur at the central auditory level.

 

Again I have hopes that u are right...but i still can not be happy if AUT63 or OTO311 works well for acute t (up to 3 months). Economy, and money, it is all about it. As @dan stated it is so much in Autifony hands, for us.

If u have a cure for some condition that torture people for 1, 2, 3 months and it is effective inside of that window, no one will not invest BIGG money to find a cure fo people that has it for a years...sad but it is a truth...

In HIV stage u can live with NEW generation of drugs up to 30-50 years. But in AIDS stage it is game over.

 

I see your side of the argument. But there is still going to be lots of money in the people that already have chronic T, and the future people with it because as we can see from trials, the acute drugs in development right now don't help everyone. Also, a huge number of veterans come back with tinnitus and they may not have the opportunity to get the proper treatment in the specific window. So there is still going to be a market. One last point is that there are a few drugs in development (aut, am-101, sf0034, oto) that are very close in timelines so just because one turns out to be effective doesn't mean the others will immediately drop from development. The drug market has multiple options for many conditions, I don't see why tinnitus will be any different. So lets just stay hopeful.

 

You do realise that the HIV analogy is not a very good one? The AIDS stage is actually the "acute" stage where the virus has destroyed the immune system and the stage before that is the "chronic" stage where the virus is under control and you can live for years without complications.

However there is still A LOT of research being done in treating both HIV and the AIDS-stage. The reason why the AIDS stage is hard to treat is due to the complexity of the illness and the fact that the patients are near death. They start developing all kinds of OTHER sicknesses. Certain types of cancers for instance. And that is not easy to cure. Also the medicines that have been developed for HIV don't work forever. The virus mutates eventually and becomes resistant to the drug you might have been taking for a long time and you have to pray that a different kind of HIV drug will work. Therefore new types of HIV drugs have to be developed continuously.

And because of the complexity and the rate of mutation of the virus a cure has so far been impossible to make.

But the research hasn't stopped! And probably never will.

The same goes for tinnitus. There are researchers that are chronics. One of the leading scientists here in Sweden that has just been granted a large sum of cash to continue his research on tinnitus and hearing loss at Karolinska Medical Institute has chronic tinnitus. And he is probably not the only one in the field. I don't think he will ever stop. I know I wouldn't.

And don't you think it's jumping the gun a bit when you proclaim doomsday prophecies just yet? So far there have been 0 drugs for treatment of tinnitus. 0! That is for all stages (so far they have only tested drugs originally designed for other conditions but there hasn't been a single one designed specifically for tinnitus). The first one in the pipeline is in stage 2 and you are already panicking as if it's the end just because it fails.

And there are more drugs coming though the pipeline. Auris Medical has announced not so long ago that they have AM-102 in the pipeline. And it's for treatment of chronic tinnitus. So far they have just selected the compound and are in the infant stages but that shows to prove that it doesn't end with AUT00063.

 

Well, I can not agreed about acute/chronic phase od Hiv/Aids, literally u have some point, but logic is different.
If we compare Hiv and t, Hiv phase is analog to acute t phase, that window period when u can react timely and live more 30/40 years. Like in acute t. if AM101 works, if u react timely after acoustic trauma u will have nice chances to live without that stupid sound.

And about AM102, if it will work, than AM101 will become useless. Seems logical to me, if something cures chronic t, it will cure acute, with better results I suppose.

Again, I am totally on your side with my hopes and wishes, but just I am still convinced that great AM101 results (eventual) is not good for chronic t research. Economically, logically etc...

Hope u do not mind for opposite opinions.
Best M.

 

I don't get it...

 

AM-101 is by no means a "cure". As any other drug will be. Drugs for acute stages will probaly not be 100% effective for a long time. If ever.

AM-101 has in the trials shown to be able to decrease the volume but it's no cure.

Therefore there will allways be a demand for drugs that treat the chronic stage.

Even if a drug to treat the acute phase is 99% effective, 1% of all the people that suffer from tinnitus is still a hell of a lot of people.

 

I think there is a scenario where this could be a good thing. That scenario is that Aut/OTO/AM and the sf drug all make it to market and are safe to be taken together. If that is the case then they would be able to work in tandem with aut/oto/am lowering the volume and sf preventing it from going back up. For me at least part of the reason T is so hard for me is the fact that I can't enjoy many things I love because of the noise. Imagine not only having low to no T, but also not having to worry about it spiking back up from noise exposure. That said this scenario has a lot of big IF's, but at least we can hope.

 

They got their approval for Phase I in healthy patients. Damn, I wish they do unhealthy people to start:

http://investors.otonomy.com/phoenix.zhtml?c=234082&p=irol-newsArticle_Print&ID=2093930

 

Well, OTO311 is not gonna be useful for us... so don't be disappointed about the slow progress..

 

don't forget am-102 guys. isn't that for chronic tinnitus?

 

I found this interesting study concerning the drug infusion using gacyclidine that Otonomy is proposing. I am currently on the AM-101 trial and I experienced similar results with the esketamine injections Auris is performing. Day 3-4 I saw some improvement, I remained near baseline for a couple of weeks before I improved. I had a great 1.5 months where I was slowly improving before returning to baseline a little after 2 months. I also experienced the ceasing of my lower frequency ringing, but was left with the higher frequency like the few subjects in this study. The attached study was not placebo based, but the results are interesting. The study also mentions that the injections only appear to work in the acute stage, perhaps to six months. Auris is finding the same thing with AM-101 and are currently focusing on the 3-6 month range.

 

I agree that the tinnitus research will target both acute and chronic. Think of the number of war veterans that returns home witch chronic tinnitus... Also the number of people affected by tinnitus increases every day, so good treatments (or even a cure) will come.

 

War veterans have been coming home with tinnitus for decades: WW2, Vietnam, Iraq 1 & 2... With hearing disorders being the number #1 disability payment item for US veterans, you would think that the US armed forces would be in a rush to do something about it. But no, that is not the case: Team Trobalt has a contact - a researcher - within the US armed forces, and, their main focus is so-called management therapies (e.g. CBT, TRT).

That's not how the world works. The world (that is society, governments, and individuals) are pretty incompetent at, well, anything really - two specific examples to illustrate:

• We live in 2015, and yet still some 10% of mothers smoke during pregnancy. Yes... that's one in ten. You would think that with so much public knowledge in relation to the dangers of smoking, and with something so important as the health of (their own) babies, that such a statistic would be closer to 0% than to 10%. But no. And that's not even taking possible legislative measures into account - which - again would be very feasible to implement (e.g. carbon monoxide screening). So... if we cannot get such a simple and obvious step right, how do you expect individuals and governments of this planet to be able to solve a hard multi-origin problem like tinnitus?
• Uveitis (eye inflammation): like tinnitus, uveitis, is currently under-researched. Uveitis is often relapsing and may be caused by an autoimmune disorder. People who suffer from it will often need to undergo heavy meds (with lots of side-effects) to control out-breaks and will sooner or later end up with vision impairment. Within stem cell therapy circles it is well known that stem cells can halt an autoimmune disease, and, the very first stem cell treatments with regenerative stem cells took place back in 2003 (in China). That's +10 years ago. With something as important as the vision, utilizing all available therapy options should be a no-brainer. But do you see stem cell therapy on offer at your local eye clinic (or anywhere)? I don't...

Moral of the story: don't have too much faith in anything. Governments, society, and individuals are pretty much hopeless at most things.

attheedgeofscience
29/OCT/2015.

 

It would still be interesting to see if there has been any progress in all the things you mention. If we compare how much veterans received in disability checks after WW2 and today I would bet it's a lot more today. It would also be interesting to see how many women smoke during pregnancy compared to let's say only 20 years ago. Once again I think we would see different figures.

Also when it comes to research we didn't have the tools after WW2 or other historic wars that we have now. Research in medicine goes a little hand in hand with other technological advancements.

I don't get this logic with just saying "It's 2015..." followed by something negative about society. Yes it's 2015, last year was 2014 and 10 years ago it was 2005. What does it matter? Is there some magic number, some goal that we are supposed to reach or were supposed to reach by 2015? What's so special about it being 2015? I'm betting people were saying things like "It's 1909 and still the car isn't a common transportation." Or "It's 1645 and everyone still doesn't have an own musket."

Either way we are sure as hell in a much better place now than 50 years ago, or 100 years ago. And that's the only thing that matters. That we progress.

 

The point is that:

• "You" fix matters which belong to the "low-hanging fruit" category
• That - in the year 2015 - we are well into the 21st century

What percentage of women smoked during their pregnancy 20 years ago is irrelevant: the figure should be zero (now, regardless). No need for comparison. The only people who care about such comparisons are those with mediocre standards. In any event, the real measure is what percentage of women who smoke today - which - is about 20%. Put another way: in the year 2015, it is only about every other mother who quits smoking during pregnancy. And that revelation is shocking (to me).

As an example of low-hanging fruits, here is what I wrote to the EU's directorate for health and consumers, last year...

www.tinnitustalk.com/threads/bta-refuses-to-fund-drug-and-stem-cell-research.6599/#post-72413

Now ask yourself how much has been achieved since (i.e. handing out ear plugs at concerts all over EU would be very easy to implement - or should be...).

 

I don't agree. A close example to show you the capabilities of human ingenuity is your very own computer from which you have posting messages to this board. One computer chip has ten times more complexity than the whole infrastructure of the city in which you live... and this chip is made by humans on a scale of milimeters.

Expecting that rationality will be the only driving power behind progress is a very naive believe that will lead to disappointment. We just need to accept that human behavior is based on many factors which of some are rational and most are irrational (like the smoking of mothers).

My opinion on this matter: We have a long journey in front of us. Otonomy may bring a solution for some of us, but the odds of them failing too are high. Despite this I still believe one day there will be an Einstein who cracks the puzzle.

 

I personnally am amazed to read that kind of stuff in 2015 ...yeah sure we could screen them, and then if we find carbon monoxide what should we do ? Some eugenist measures maybe ?
The come back of old fashioned late 19th/early 20th centrury's eugenism coupled with nowadays technology would be fucking scary and I would definitely not want to live in such a society ....

 

I am simply approaching this from a logical perspective using comparisons (as I generally do). Whether or not screening should take place, I do not know, but I do know this much:

• Just about any country in the Western part of the world has seen restrictions on smoking in public and at work places (fair or not, I am not to judge). Now comes the point of logical inference: if legislative measures are brought forward to protect, say, office workers from 2nd hand smoke, then why not (also) protect unborn babies? Are office workers somehow more important?
• Screening is already used in many places: breathalyzer tests for motorists, drug tests in schools, drug tests at work places, drug testing for army recruits, etc. Now, people may think that such tests interferes with their personal freedom. That is of course a matter of personal opinion, but again, I do know this much: if we can - as a society - accept/tolerate screening for such a wide area of the population (e.g. schools, work, driving) then why not for a sub-set of society such as pregnant mothers? Again... just a logical inference here.

You already do. See 2nd bullet point, above.

Carbon monoxide screening has nothing to do with eugenism. Bringing forward "favourable genes" (i.e. desirable traits such as colour of hair) - that's eugenics (as opposed to ensuring the best possible health of existing genes - regardless of, say, colour of hair).

In addition, you might want to see this:

http://tobaccofreefutures.org/news/uk-experts-call-for-national-co-screening-for-all-mums-to-be/

Lastly, just to keep this thread a little "on-topic" in relation to tinnitus/hearing, I would like to mention that modern studies keep highlighting new ways that smoking affects unborn babies. Previously it was generally accepted that only seriously underweight babies (< 1750 grams) would have a chance of impaired hearing. However, it is now known that smoking during pregnancy leads to a 3-fold risk of mild hearing loss (regardless of weight of babies):

http://www.nvrc.org/2013/07/study-l...while-pregnant-to-hearing-loss-in-adolescents

Now... the above is just one area of health that smoking during pregnancy affects. There are many more. If you think it is reasonable that children should be born with defects to their hearing, and perhaps increased risk of developing tinnitus later on, that is of course your choice. But I think otherwise.

Lastly, here is a comparison photo of what happens to the movements of a fetus when a mother smokes:



Top series of photos: smoking mother
Bottom series: non-smoking mother

attheedgeofscience
30/OCT/2015.