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

[attheedgeofscience]

Thanks for sharing, I agree it's not automatic, but isn't the AM101 still in phase 2?

My comment is for drugs in phase 3.

It's in phase III: http://clinicaltrials.gov/show/NCT02040194

 

[benryu]

It's in phase III: http://clinicaltrials.gov/show/NCT02040194

Wow nice to hear, did they publish any detailled results ?

Damn they were fucking douchbags not to let you in.
But isn't it because it's for acute tinnitus ? Maybe they were scared you would affect their data ?

 

[attheedgeofscience]

Considering the extraordinary lengths you went to get help, these people must be pretty damn heartless.

I wonder if the CEO would have been as obstructive if the patient in question was his own child. Probably not.
I wonder if a million pound donation would have swayed it to get another person on the trial. Probably.

They knew that you were on the verge of death. You don't have to be a practising Christian to
feel empathy for a fellow human being, especially if he is offering to PAY for help!

This is no nasty indictment on mankind, merely bad karma for the unfeeling greedy paranoid cyborgs at Auris.

Any of us would have helped you FOR FREE.
This sort of thing would make for a powerful article.
May none of them profit from our misery.
If you ever bump into the CEO one day, kick his ass - for all of us.

Thank you (although I do not plan to go as far as you suggest...)

Objectively speaking, I can certainly see it from "their" side ie. if they start releasing the drug for off-label purposes, then "the whole world" could/would start coming forward and request the same thing (although I don't know the exact reason why they chose not to release the drug; the pharmacist from AM simply stated that the Board of Management had chosen not to release it - and it was a decision made "on the spot" ie. within a couple of hours after my doctor requested it). I don't really hold a grudge against Auris Medical (believe it or not). However, just as it is their right to say "no", it is equally my right to go public about it (as long as what I write is accurate and true - and it is; as I say, I have documented my "claims" with Markku - in case anyone doubts it).

Basically, I just think it is a shame that there is a drug which potentially could help me and/or others in my situation - and then not being allowed use it...

 

[attheedgeofscience]

Wow nice to hear, did they publish any detailled results ?

http://www.aurismedical.com/newsroom/publications

But isn't it because it's for acute tinnitus ?

True. But I was within the one year time limit at the time. In any event, when things are done off-label, there is no need to conform to the requirements of the study (because the patient is not part of the study). And lastly, the decision had nothing to do with me personally; it was a matter of principle that they wouldn't release the drug.

Maybe they were scared you would affect their data ?

Study data cannot be affected by off-label procedures. Patients who have off-label interventions are not recorded.

 

[benryu]

http://www.aurismedical.com/newsroom/publications

True. But I was within the one year time limit at the time. In any event, when things are done off-label, there is no need to conform to the requirements of the study (because the patient is not part of the study). And lastly, the decision had nothing to do with me personally; it was a matter of principle that they wouldn't release the drug.

Study data cannot be affected by off-label procedures. Patients who have off-label interventions are not recorded.

Damn man, I feel really sorry to hear that, it's lame they did not let you use it.
Did they give you more information about why they considered your use as "off label" if it was in the 12months frame ?

 

[attheedgeofscience]

Damn man, I feel really sorry to hear that, it's lame they did not let you use it.
Did they give you more information about why they considered your use as "off label" if it was in the 12months frame ?

The term off-label is applied whenever a drug is used outside a clinical study or for other purposes than the drug is indicated for. It is not so much a matter of whether or not I would conform to the requirements of the study - it is the simple fact that I was not part of the study that made the use "off-label".

The reason I was/could not be part of the study was because:

1) I am Danish, but living in Germany (and only German nationals can take part); there is no clinical trial in Denmark.
2) I did not really want to take part in the study (even if I could) because I wanted both ears treated - and I wanted to make sure I didn't end up getting the placebo.

When drugs are used off-label, the patient normally signs a document releasing the doctor of responsibility and pays for the procedure (just like they would with any other medical intervention). For this reason, the drug can be used pretty much any way the patient and doctor agree to (amongst themselves). The drug provider has no influence over that. All the pharmaceutical company has to do is release the drug. No more, no less.

I suppose there is a potential risk in having clinical trial doctors perform off-label interventions - especially when these are double-blind - because that way the doctor could potentially influence the results of the study (by manipulating the drugs that are double-blind with the ones where the content is known to be the real drug ie. off-label).

[Defn double-blind: neither the patient nor the doctors knows if the real drug or the placebo is administered.]

 

[benryu]

The term off-label is applied whenever a drug is used outside a clinical study or for other purposes than the drug is indicated for. It is not so much a matter of whether or not I would conform to the requirements of the study - it is the simple fact that I was not part of the study that made the use "off-label".

The reason I was/could not be part of the study was because:

1) I am Danish, but living in Germany (and only German nationals can take part); there is no clinical trial in Denmark.
2) I did not really want to take part in the study (even if I could) because I wanted both ears treated - and I wanted to make sure I didn't end up getting the placebo.

When drugs are used off-label, the patient normally signs a document releasing the doctor of responsibility and pays for the procedure (just like they would with any other medical intervention). For this reason, the drug can be used pretty much any way the patient and doctor agree to (amongst themselves). The drug provider has no influence over that. All the pharmaceutical company has to do is release the drug. No more, no less.

I suppose there is a potential risk in having clinical trial doctors perform off-label interventions - especially when these are double-blind - because that way the doctor could potentially influence the results of the study (by manipulating the drugs that are double-blind with the ones where the content is known to be the real drug ie. off-label).

[Defn double-blind: neither the patient nor the doctors knows if the real drug or the placebo is administered.]

Ok I understand, thanks for all the details.
I really wish I could help.

 

[john2012]

if they start releasing the drug for off-label purposes, then "the whole world" could/would start coming forward and request the same thing ...

I honestly doubt the 'world' would come knocking on their door.
I bet it's only highly-motivated and well-informed, responsible tinnitus patients like yourself.
Auris might understandably turn away dubious non-target market applicants,
but by all accounts, your use of the drug would be pretty 'on-label'.
Amongst other things, you simply want to guarantee not wasting time with a placebo,
which is an excellent valid point.

the pharmacist from AM simply stated that the Board of Management had chosen not to release it - and it was a decision made "on the spot"

obviously a well-considered and thought-out humanitarian decision, not.

I don't really hold a grudge against Auris Medical (believe it or not).

We believe you. But Auris are going down.

However, just as it is their right to say "no", it is equally my right to go public about it (as long as what I write is accurate and true - and it is; as I say, I have documented my "claims" with Markku - in case anyone doubts it).

They have the right to say no, but in so doing they put themselves in the most dismal light.
Bearing in mind your efforts, they SHOULD have allowed you the drug as an act of COMPASSION.
Would it really have done them any harm to do so, of course not.

Good idea to document with Markku, but your integrity is respected and intact.

 

[SteveToHeal]

We believe you. But Auris are going down.

I love all the comraderie... but can you qualify why Auris are "going down?"

 

[john2012]

I love all the comraderie... but can you qualify why Auris are "going down?"

This is a phrase i got from my 11 year old son, when he's about to kick his
big brother's ass on our garden trampoline, cage fighting at its deadliest.
Auris simply can't mess with our homie edgeofscience like this without invoking
pretty bad karma. My 11 year old son would probably agree with me.

I imagine their share price may crash after AM101 is found to be made of pure turkey
and the meanie butt board of directors end up cannon-fodder extras in Expendables 7.
It happens.

Good question Steve!

 

[Benja]

IM sorry, my enlighs its not very good, but this means there is actually a real treatment coming?...this is not some made up stuf,, this is real scien. and its just a matter of time?

 

[RichL]

IM sorry, my enlighs its not very good, but this means there is actually a real treatment coming?...this is not some made up stuf,, this is real scien. and its just a matter of time?

Yes Benja this is being looked at as a cure but it is still in the trial stages but looks very promising, If anything this gives us all a little bit of hope!

And yes this is real science!

Rich

 

[Christian78]

I would like if we could make a pool, voting on people who believe and hope in Autifony, and people who dont believe in it.

Also one more pool people who are ready to sign petition for faster release of drug on market (end of phase 2), and those who would not sign petition but wait phase 3 to finish... (we can vote because there ate accelerated approvals on medication special for neurological diseases).

can we put it to see opinions?

 

[Benja]

Thank you veyr much to all for your reply. Once again. Im sorry for my english, and RichL you understood perfectly what I was trying to ask. Thanks to everyone for your consideration.

 

[benryu]

I would like if we could make a pool, voting on people who believe and hope in Autifony, and people who dont believe in it.

Also one more pool people who are ready to sign petition for faster release of drug on market (end of phase 2), and those who would not sign petition but wait phase 3 to finish... (we can vote because there ate accelerated approvals on medication special for neurological diseases).

can we put it to see opinions?

I am totally in, even if I have pay money for that $_$

 

[Ken219]

Before we get too excited will someone please follow the people at Autifony just to make sure they aren't on a yacht sipping martinis.

 

[Christian78]

Well their trials for tinnitus is not going to be financed by them, but by credits and grants from government, (as their statement). I wonder what government give credits and grants to unsure medicine. I am sure they did test it on volunteers, but to get approved as medicine it needs to do phase 2, with placebos, real medication to prove is is EFFECTIVE.

As accelerated approval medication they can get approved before end of phase 2, if they show that as they did pre-phase on mouses highly efficient, phase 1 showed it is not dangerous and can be mixed with other medications, and it is not dangerous on higher dosages., if phase 2 shows that it is extremely good in comparing to placebo, and 2B shows that again dosage dependent can help also even if dosage is higher (daily dependent) but shows that medicine is effective, medicine can be approved before end of entire phase 2.

 

[benryu]

Well their trials for tinnitus is not going to be financed by them, but by credits and grants from government, (as their statement). I wonder what government give credits and grants to unsure medicine. I am sure they did test it on volunteers, but to get approved as medicine it needs to do phase 2, with placebos, real medication to prove is is EFFECTIVE.

As accelerated approval medication they can get approved before end of phase 2, if they show that as they did pre-phase on mouses highly efficient, phase 1 showed it is not dangerous and can be mixed with other medications, and it is not dangerous on higher dosages., if phase 2 shows that it is extremely good in comparing to placebo, and 2B shows that again dosage dependent can help also even if dosage is higher (daily dependent) but shows that medicine is effective, medicine can be approved before end of entire phase 2.

Yes I confirm what Christian said, plus this study is led by the Professor Deborah Hall, I don't know her personally, but I am very familiar with her work, and I have to say she's one of the best and most specialized researcher in the field.

In my humble opinion, she's pretty much the best lead we could get for such a study.

If you want to know more about her, I encourage you to read some of her latest publications (http://www.nottingham.ac.uk/medicine/People/deborah.hall).


EDIT:
One extra comment, her latest publication:"Auditory network connectivity in tinnitus patients: A resting-state fMRI study" is very encouraging when I think about the AUT00063, because she demonstrated that the auditory network connectivity does not appear to be reliably altered by the experience of chronic tinnitus.
In other word, tinnistus is most likely more isolated than we though and hence "easier" for a drug to be targeted.

Read More: http://informahealthcare.com/doi/abs/10.3109/14992027.2013.846482

 

[Snake Plissken]

if phase 2 shows that it is extremely good in comparing to placebo, and 2B shows that again dosage dependent can help also even if dosage is higher (daily dependent) but shows that medicine is effective, medicine can be approved before end of entire phase 2.

This is true, but faster approval is generally reserved for drugs needed urgently... Don't get me wrong, I think a better T treatment *is* needed urgently, but perhaps whatever governing body oversees these things will not feel the same way - especially when they're looking at it in relation to cancer drugs, heart medications, etc.

 

[Grace]

So

Yes I confirm what Christian said, plus this study is led by the Professor Deborah Hall, I don't know her personally, but I am very familiar with her work, and I have to say she's one of the best and most specialized researcher in the field.

In my humble opinion, she's pretty much the best lead we could get for such a study.

If you want to know more about her, I encourage you to read some of her latest publications (http://www.nottingham.ac.uk/medicine/People/deborah.hall).


EDIT:
One extra comment, her latest publication:"Auditory network connectivity in tinnitus patients: A resting-state fMRI study" is very encouraging when I think about the AUT00063, because she demonstrated that the auditory network connectivity does not appear to be reliably altered by the experience of chronic tinnitus.
In other word, tinnistus is most likely more isolated than we though and hence "easier" for a drug to be targeted.

Read More: http://informahealthcare.com/doi/abs/10.3109/14992027.2013.846482

so this is good information right? Like chronic T may be easier to treat by drugs more then we thought?

 

[benryu]

So

so this is good information right? Like chronic T may be easier to treat by drugs more then we thought?

The exact information is that chronic T. is not affecting the entire auditory system, we knew from a previous study that T. was coming from a specific part of the brain, but we had no confirmation that this malfunction was not affecting the rest of the auditory "circuit".

In other words, it confirms that this is relatively isolated, that the circuit will work normaly if the T. signal is being stopped and this system is perfectly healthy.

Eventually it's easier for a drug to adress a specific problem than a multiple problems or a systemic problem.

 

[benryu]

This is true, but faster approval is generally reserved for drugs needed urgently... Don't get me wrong, I think a better T treatment *is* needed urgently, but perhaps whatever governing body oversees these things will not feel the same way - especially when they're looking at it in relation to cancer drugs, heart medications, etc.

You're right, but the problem is not so manichean I would say... And there are solutions in between.

First, the idea of a drug needed urgently is not necesseraly based only on direct cause of death, as example health issue leading to higher chances of suicide, depression, or any not so happy outcomes is being taken into account.
Today in NA, T. is considered as a pretty solid factor of invalidity and any drug being a game changer in terms of invalidity is also being taken into acount.

The economic & strategic aspects are also being weighted, if this cures works it will save millions (if not billions) to governements.
Lobby such as the ATA, or massive petitions can also make a difference.

In my opinion I don't necessarely believe that we will get a fast track for this drug, but we could certainly get a very (very) large phase 3, or case by case fast tracks with your ENT & a couple of discharge papers.

 

[Stina]

You're right, but the problem is not so manichean I would say... And there are solutions in between.

First, the idea of a drug needed urgently is not necesseraly based only on direct cause of death, as example health issue leading to higher chances of suicide, depression, or any not so happy outcomes is being taken into account.
Today in NA, T. is considered as a pretty solid factor of invalidity and any drug being a game changer in terms of invalidity is also being taken into acount.

The economic & strategic aspects are also being weighted, if this cures works it will save millions (if not billions) to governements.
Lobby such as the ATA, or massive petitions can also make a difference.

In my opinion I don't necessarely believe that we will get a fast track for this drug, but we could certainly get a very (very) large phase 3, or case by case fast tracks with your ENT & a couple of discharge papers.

I just wanted to add that due to the noise levels in everyday life and concerts, Ipods etc an epidemic of hearing problems is expected by 2020.If anyway findss a treatment/cure they will literally be millioners. What would be more motivating to governments and scientists in a capitalistic world?

 

[Rhea]

I was just siting here thinking that possibly ....... somewhere, like 45 minutes away from me, (I live close to UCL London where some of the aut' trials are taking place) there is a little pill, sitting on a side, in a lab, that could possible change my life beyond my wildest dreams.........quite a strange and overwhelming thought.......

......just saying

 

[RichL]

Must make you think about going for a walk and being a burglar just this one time Rhea! lol, I know I would be tempted!

 

[Grace]

I just wanted to add that due to the noise levels in everyday life and concerts, Ipods etc an epidemic of hearing problems is expected by 2020.If anyway findss a treatment/cure they will literally be millioners. What would be more motivating to governments and scientists in a capitalistic world?

i dont want anyone to have hearing loss or T, but if by 2020 its real bad then they will be hauling ass to get something to work hopefully!

 

[Stina]

i dont want anyone to have hearing loss or T, but if by 2020 its real bad then they will be hauling ass to get something to work hopefully!

They are doing it right now and if the drug works it will be out by 2020. In my opinion the situation in tinnitus research is a lot better than for example people with ALS because we dont die and quite a lot of people would pay good money to get healed. If it were a rare condition with many deaths the situation would be a lot more hopeless..

 

[benryu]

They are doing it right now and if the drug works it will be out by 2020. In my opinion the situation in tinnitus research is a lot better than for example people with ALS because we dont die and quite a lot of people would pay good money to get healed. If it were a rare condition with many deaths the situation would be a lot more hopeless..

I agree, this is a widespread problem , it's like 10% to 15% of the population who is affect by T.
2020 sound like a very (very) likely deadline considering the financial stakes and I do believe that we will get some stuff way before that.
The AM-101 is a first step for acute T. and is already in phase 3 with good results in phase 2.
The AUT00063 is very promising for chronic T. and is about to start phase 2 and I expect a lot of us to have early access to this drug (if woking) by the end of 2015 in a large scale phase 3.
More is coming with this virus found that helps mamals to regrow haircells, or the numerous research projects in most major pharma groups.

I am not worried at all, and I know that each day is a day closer to a cure.

 

[Grace]

I agree, this is a widespread problem , it's like 10% to 15% of the population who is affect by T.
2020 sound like a very (very) likely deadline considering the financial stakes and I do believe that we will get some stuff way before that.
The AM-101 is a first step for acute T. and is already in phase 3 with good results in phase 2.
The AUT00063 is very promising for chronic T. and is about to start phase 2 and I expect a lot of us to have early access to this drug (if woking) by the end of 2015 in a large scale phase 3.
More is coming with this virus found that helps mamals to regrow haircells, or the numerous research projects in most major pharma group.

I am not worried at all, and I know that each day is a day close to a cure.

Shit, idc if it takes autifony until 2025 to release it. As long as it shows that its insanely effective with a large trial then at least we know we got a shot down the road to get it.. Plus that might just help people habuitate alot quicker knowing there will be help sooner then later.. How i think anyways! But wow if we could get this By 2015/16 by participating in trials or something ill totally do it.

 

[Stina]

Shit, idc if it takes autifony until 2025 to release it. As long as it shows that its insanely effective with a large trial then at least we know we got a shot down the road to get it.. Plus that might just help people habuitate alot quicker knowing there will be help sooner then later.. How i think anyways! But wow if we could get this By 2015/16 by participating in trials or something ill totally do it.

They will start the trials already this autumn. However I think they are mostly doing it in the Uk. Maybe phase 3 will be in US as well but who knows. Considering that so far it has taken them around 1,5 years for a phase + planning the next one then if everything goes fine they will be finished it 5-6 years + some time to get on the market. 2025 is realistic only if they fail and have to make improvements.