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

[dan]

@attheedgeofscience
Oh I'm sorry, from your post saying -
"However, as I am someone who dislikes to assume anything, I can give Mr. Large a follow-up call on Monday - no problem. But, I am so certain in my assumption, that I would not normally even bother (basically, I would just be doing it as a service towards this board; I know how these things work...)."
-I was under an impression that you had his phone number and/or spoke to him personally
If I knew you didn't have his number I wouldn't of bothered asking, as I am not the least bit surprised Dr.Large isn't going to publish his private number. Apologies.

 

[attheedgeofscience]

@attheedgeofscience
Oh I'm sorry, from your post saying -
"However, as I am someone who dislikes to assume anything, I can give Mr. Large a follow-up call on Monday - no problem. But, I am so certain in my assumption, that I would not normally even bother (basically, I would just be doing it as a service towards this board; I know how these things work...)."
-I was under an impression that you had his phone number and/or spoke to him personally
If I knew you didn't have his number I wouldn't of bothered asking, as I am not the least bit surprised Dr.Large isn't going to publish his private number. Apologies.

Dan, I understand your disappointment, but when I said "no problem", I meant giving him a call shouldn't be problem ie. I would not have a problem doing so. I work in finance, and looking up financial and company data is something I do all the time. For that reason, I assumed that I would be able to reach him (via phone, as I had already reached him via e-mail - something I clearly stated earlier on). For instance Auris Medical has their phone number listed:

http://www.aurismedical.com/contacts

And as I have also mentioned in an earlier post, My father - on my behalf (because he lives in Switzerland) - has been in direct contact with Mr. Meyer back in April/May. Again, "no problem". Any company which has a capital injection of USD +20 M would normally also have a phone number. If you get my meaning...

 

[dan]

Half this board has sent Dr.Large an email to which he answered lol.
I have also contacted with Dr.Meyer via email and he replied to me that I cannot participate in a US trial as a Canadian citizen (that was when it was still only available in the US).
But I really doubt that your father has personally spoken with Dr.Meyer on the phone.

 

[Erlend]

Half this board has sent Dr.Large an email to which he answered lol.
I have also contacted with Dr.Meyer via email and he replied to me that I cannot participate in a US trial as a Canadian citizen (that was when it was still only available in the US).
But I really doubt that your father has personally spoken with Dr.Meyer on the phone.

Why would you doubt that? He's not the president of the US..

 

[dan]

I stand corrected ...

 

[SteveToHeal]

When in September did Autifony say they would post details of their trial?

 

[rtwombly]

They say late summer on their page. It's not hard to find.

 

[Viktor Salvatore]

"Research shows that tinnitus usually arises within the central nervous system, and may be caused by increased neural activity in regions of central auditory pathway. Thus treatments for tinnitus need to focus targets within the brain, and not the cochlea."

That is whole point, when world medicine finaly recognize that, T could be resolved....until that talking with old knowledge ENTs is wasting a time...

I agree. ENTS are a waste of profession...all they do is give you a hearing test and scope your throut and ears with a light and send you hopeing with Tinnitus while telling you to live with it....there such a waste of profession. NO value added from that profession......anything they can do can be done by an audiologist with respect to ears. Why do they exist?

 

[SteveToHeal]

I agree. ENTS are a waste of profession...all they do is give you a hearing test and scope your throut and ears with a light and send you hopeing with Tinnitus while telling you to live with it....there such a waste of profession. NO value added from that profession......anything they can do can be done by an audiologist with respect to ears. Why do they exist?

When it comes to T, I could not agree more. My employer will not accept recommendations re my condition from my audiologist as valid. They insist on an ENT. Yet an audiologist (a good one) works with T patients every day and understands the plight of the T sufferer and how it impacts their lives and jobs, sometimes causing a person to lose their job, myself potentially in that category.

All an ENT will say is chin up and soldier on. A good audiologist will say this guy/gal needs help and either 1) Book him/her off or 2) Give him/her some leeway in their job until they either 1) Learn to manage it or 2) Be part of a clinical trial to try and improve it. Maybe a "work from home" setup until T is manageable...?

In a profession that requires intense concentration... i.e. most stressful jobs today... the T sufferer has absolutely no chance of getting help from the medical world for proof to their employer that they have a SERIOUS condition (a serious disability). Yet employers insist on an ENT report... and we know how that will go. No disability. Get on with your life. It makes me want to scream.

Anyway... I don't want to avert this thread from Autifony. Just wanted to agree with Viktor Salvatore on the absolutely uselessness of ENT's today on anything to do with T and share my frustration. They have no right to even diagnose on it.

 

[Viktor Salvatore]

I would gladly trade tinnitus for impotence.

I would gladly give up master.....g for a life of silence.

 

[t-man]

I've mentioned this before but sticking the human ear, a complicated sensory organ, with your head's pluming pretty much indicates how under researched and developed our medical knowledge of the ear is.

Eyeballs have their own doctors and specialist. Ears don't. We have a lot of technology available to fix the eye. Again, ears don't.

 

[RichL]

Your right, it seems as if someone said, well your ears pop when you swallow so we will just lump them in with the throat and nose!

Very primitive thought process I would have thought!,
It's like the ears have been left behind in the technology stakes!

 

[Stina]

Your right, it seems as if someone said, well your ears pop when you swallow so we will just lump them in with the throat and nose!

Very primitive thought process I would have thought!,
It's like the ears have been left behind in the technology stakes!

but we have audiologists? they are specialized on the hearing whereas ENTs deal with infections and the like.
also there are special nosesurgeons nowadays - its not simple in this sphere as well.

 

[dan]

ENT's remove tonsils - that's their job.

 

[SteveToHeal]

but we have audiologists? they are specialized on the hearing whereas ENTs deal with infections and the like.
also there are special nosesurgeons nowadays - its not simple in this sphere as well.

Agreed. Audiologists are specialists. Yet they are not qualified to give consent or advice to an employer, for example, on a T patient. Employers only accept a report from an ENT because they see them as specialists and more qualified.

ENT's are NOT specialised in T. They don't know the damnedest thing about it and can only say our employer, he/she needs to to learn to live with it.

There is no protocol in the workspace for T sufferers to make any sort of disability claim. It is a serious issue that is not being addressed. And it is because the phrase "learn to live with it", perpetuated by ENT's worldwide, that any sort of temporary disability can be granted.

A big part of my own stress and as a result, increased T, has been to mange my work situation after getting T. This should not be something else we need to fight on top of having this awful condition. An audiologist should just be able to give you a report, saying person X has Severity 5 T and unable to function as before. Person x can then temporarily apply for a benefit and that it is paid out by their health insurance policy. A mandatory policy that most employee contracts insist on today.

Instead, your job is all of a sudden on the line because you can't concentrate like you used to, you're exhausted 24/7, anxious and depressed. It is a big problem that needs to change.

Again, I do not want to divert the thread from Autifony AUT00063 . @Markku - perhaps this discussion can be moved to a separate thread "ENT's ineffective against T"?

 

[Robb]

Do we have any news if 63 (hopeful new abbreviation on this forum ) has any positive effects on lowering T?

 

[Stina]

Do we have any news if 63 (hopeful new abbreviation on this forum ) has any positive effects on lowering T?

No. The trials will start in the autumn.

 

[SteveToHeal]

No. The trials will start in the autumn.

Does anyone have an idea how many trials there will be and how often? If one had to start up in the UK (tinnitus) and US (hearing loss) in September, when would they be recruting till? For example, candidates enter for am101 TACTT3 over a number of months. It takes time for rnd to recruit throughout the designated countries and end up taking people in at different times until the "worldwide" quota is met. It could take a year or so to get the numbers. The same should surely be true for Autifony. They might open applications in September but applications could essentially close as late as April next year. Thoughts anyone? Given that we have some speculative eligibility criteria of time since T onset < 18 months, then it does give some of us a window potential to land a spot on the trial.

 

[dan]

Does anyone have an idea how many trials there will be and how often? If one had to start up in the UK (tinnitus) and US (hearing loss) in September, when would they be recruting till? For example, candidates enter for am101 TACTT3 over a number of months. It takes time for rnd to recruit throughout the designated countries and end up taking people in at different times until the "worldwide" quota is met. It could take a year or so to get the numbers. The same should surely be true for Autifony. They might open applications in September but applications could essentially close as late as April next year. Thoughts anyone? Given that we have some speculative eligibility criteria of time since T onset < 18 months, then it does give some of us a window potential to land a spot on the trial.

For goodness sakes, its only a phase 2 trial with only a couple hundred trialees.
you seem to confuse phase 2 with phase 3 (thousands of guinea pigs). It would take them about 2 months to recruit 200 people, they should be at the end of the trial by April next year.

 

[SteveToHeal]

For goodness sakes, its only a phase 2 trial with only a couple hundred trialees.
you seem to confuse phase 2 with phase 3 (thousands of guinea pigs). It would take them about 2 months to recruit 200 people, they should be at the end of the trial by April next year.

Well sorry for asking!!!! This is a free forum you know and anyone has the right to ask whatever question they want without being shot down. Seriously dude, I don't appreciate the "For goodness sakes". Who the hell are you anyway? It's a genuine question on time frames.

 

[attheedgeofscience]

For those who are interested in the AUT00063 clinical trial.

I have a small update regarding enrollment criteria. It is possible, but not certain, that the clinical trial will accept non-UK nationals provided they speak good English.

This is dependable information.

(I have shared the details with @Markku offline).

 

[benryu]

For those who are interested in the AUT00063 clinical trial.

I have a small update regarding enrollment criteria. It is possible, but not certain, that the clinical trial will accept non-UK nationals provided they speak good English.

This is dependable information.

(I have shared the details with @Markku offline).

Engurish good in me, takke me pleese !

 

[Zimichael]

Hey sorry if this question has been covered elsewhere, but there is just SO MUCH on this site I can hardly keep up...

OK... my question is on "Clinical Trials Requirements". Yeah, I know where to find the obvious stuff like their 'inclusions' and 'rejections' etc. as that gets posted on the trial criteria which shows up on the ClinicalTrials.gov page or the company's website, etc.
What I am more interested in is the 'setup parameters' that some of you may have experience with as I want to try my damndest to get in on AUT00063 wherever/whenever it comes up. Call it the long term plan!
Regarding current status I doubt I could get into the UK Phase II trial as there must be a huge list of candidates right there (even though I'm a US citizen I'm also a Brit/EU citizen c/o my English colonial roots). However, the moment anything in the USA shows up I want to be ready with all my ducks lined up.

So...what do these folks generally want???

~ A doctor MD saying: "Yeah this guy has Tinnitus as I gave it to him c/o ototoxic meds"?
~ Audiograms??? From how long ago, or just recent?
~ Referral c/o and ENT or Audiologist? And does it have to be by referral or can one just say: "Hey I fit the criteria!"
~ Any other stuff I am missing that are obvious "grease the wheel" things that would require documented historical evidence for when the time comes to apply. If so I want to get that evidence in good time.

My theory is, that if AUT00063 is successful, it is going to get 'fast-tracked' due to the high profile needs in the VA/military for a treatment. Someone switched-on is going to get to know about this stuff and the info will go viral with all the might of the Pentagon behind it and they will just carpet bomb any hindrances if it sounds safe...as the $$$ figures it is costing them for T treatment are staggering.

Anyway, all to say, I want to be prepared, fully, and in advance...So any tips appreciated. (Yeah, I know Retigabine is out there and ATEOS is trying Flupirtine right now, but AUT00063 sounds like the way to go even if it requires a wait. After 58 years, what the hell!)

Oh... J @attheedgeofscience are you updating your Flupirtine progress on a separate thread or on this one??? It does not seem to be available in the USA by the way, mainly Deutschland and 'Stina-land'.

Best, Zimichael

 

[rtwombly]

@Zimichael There's an advantage to AUT00063 being beneficial (hopefully) for hearing acuity. They can measure that objectively, so a hearing loss <=20dB is probably the major criteria in the US.

 

[Zimichael]

@rtwombly Ah so...Thanks, but less than or = to 20dB?! I may have to get a fake test as think one ear is more than 20dB. Anyway will cross that bridge when get to it I guess. As primarily sounds like you are confirming need for an Audiogram...which I guess I need to get updated anyhow.
Ta, M.

 

[Martin69]

Sorry for asking this question, but I am no expert in medicine.
If there is a trial II phase, I guess there was already a trial I phase.
How is this done and do they test with Tinnitus patients?
Is there no one in the world who knows the results of this phase?

 

[Jay M]

@Zimichael There's an advantage to AUT00063 being beneficial (hopefully) for hearing acuity. They can measure that objectively, so a hearing loss <=20dB is probably the major criteria in the US.

Military Veterans with combat experience and hearing loss will likely have more than 20dBs of hearing loss of one or more frequencies.

 

[attheedgeofscience]

Hey sorry if this question has been covered elsewhere, but there is just SO MUCH on this site I can hardly keep up...

OK... my question is on "Clinical Trials Requirements". Yeah, I know where to find the obvious stuff like their 'inclusions' and 'rejections' etc. as that gets posted on the trial criteria which shows up on the ClinicalTrials.gov page or the company's website, etc.
What I am more interested in is the 'setup parameters' that some of you may have experience with as I want to try my damndest to get in on AUT00063 wherever/whenever it comes up. Call it the long term plan!
Regarding current status I doubt I could get into the UK Phase II trial as there must be a huge list of candidates right there (even though I'm a US citizen I'm also a Brit/EU citizen c/o my English colonial roots). However, the moment anything in the USA shows up I want to be ready with all my ducks lined up.

I have been in contact with two people regarding the AUT00063 clinical trial: Mr. Large (CEO and sponsor of trial) and another person "on the other side of the fence" ie. the clinical trial itself. It is important to understand that the clinical trial sponsor, and the ones who actually carry out the trial, are two different entities. The sponsor is not allowed to have direct patient contact. And the executive arm of the clinical trial is double-blind (meaning they don't know what they are administering - be it placebos or the "real deal" - to the patients, even though they are doctors; consequently, the patients are just as "blind" as the doctors in a double blind trial). This is the "segregation aspect" of a clinical trial.

I doubt many people realize(d) the importance of the post I made a few entries above ie. possible enrollment of non-UK nationals in the trial. As a counter example, even if I had mother tongue German competency, I would not be allowed to participate in the AM101 clinical trial here in Germany (even though I live here and have official healthcare coverage). That's why I had to go through all the off-label "crap"...

The tinnitus clinical trial is UK based (for certain). There possibly is another clinical in the US (for hearing loss; not confirmed - at least not to me). The criteria for enrollment could well be different for those two (speculation on my part, of course).

The source "on the other side of the fence" has already told me he/she knows there will not be "enough seats" for everyone (no surprise there - this is a phase II trial ie. small numbers to demonstrate efficacy). But once enrollment is possible via the resource webpage, you should have a go at it.

So...what do these folks generally want???

~ A doctor MD saying: "Yeah this guy has Tinnitus as I gave it to him c/o ototoxic meds"?
~ Audiograms??? From how long ago, or just recent?
~ Referral c/o and ENT or Audiologist? And does it have to be by referral or can one just say: "Hey I fit the criteria!"
~ Any other stuff I am missing that are obvious "grease the wheel" things that would require documented historical evidence for when the time comes to apply. If so I want to get that evidence in good time.

You will have to wait and see, is the simple answer to that. But, I suspect that they will request something like the following:

1) Possible restrictions on how long you have had tinnitus ("possibly" - I don't know!) eg. enrollment may be restricted to candidates who have had tinnitus for up to 12 months (example only!!!).
2) No other on-going tinnitus treatments (eg. AM101 trial).
3) Medication free (or nearly so) - eg. no Trobalt in your system please...!

Again, the above is pure speculation on my part. You will probably be asked to submit a blood sample and a urine test. And possibly your medical file (from somewhere).

The person I have been in contact with has told me - as I already know - that this is a clinical trial, and there are strict procedures for inclusion/exclusion criteria. A clinical trial is not about "the patient" - it is about all the many future patients who potentially can benefit from the medication. The clinical trial itself could not care less about you. They only want people who fit the profile. Anyone on the borderline is just a nuisance to them.

My theory is, that if AUT00063 is successful, it is going to get 'fast-tracked' due to the high profile needs in the VA/military for a treatment. Someone switched-on is going to get to know about this stuff and the info will go viral with all the might of the Pentagon behind it and they will just carpet bomb any hindrances if it sounds safe...as the $$$ figures it is costing them for T treatment are staggering.

I doubt it will get fast-tracked (I can't see the specific reason why it should ie. there is no threat to humanity or likewise). The person I have been in contact with has already confirmed to me that there is much work to done. Again, no surprise there since this is just the very beginning of phase II trial.

Anyway, all to say, I want to be prepared, fully, and in advance...So any tips appreciated. (Yeah, I know Retigabine is out there and ATEOS is trying Flupirtine right now, but AUT00063 sounds like the way to go even if it requires a wait. After 58 years, what the hell!)

Oh... J @attheedgeofscience are you updating your Flupirtine progress on a separate thread or on this one??? It does not seem to be available in the USA by the way, mainly Deutschland and 'Stina-land'.

Regarding Flupirtine, I will provide an update on Monday or Tuesday after seeing my GP.

 

[dan]

I didn't know a drug can only be fast-tracked in cases of threats to humanity.

 

[benryu]

I have been in contact with two people regarding the AUT00063 clinical trial: Mr. Large (CEO and sponsor of trial) and another person "on the other side of the fence" ie. the clinical trial itself. It is important to understand that the clinical trial sponsor, and the ones who actually carry out the trial, are two different entities. The sponsor is not allowed to have direct patient contact. And the executive arm of the clinical trial is double-blind (meaning they don't know what they are administering - be it placebos or the "real deal" - to the patients, even though they are doctors; consequently, the patients are just as "blind" as the doctors in a double blind trial). This is the "segregation aspect" of a clinical trial.

I doubt many people realize(d) the importance of the post I made a few entries above ie. possible enrollment of non-UK nationals in the trial. As a counter example, even if I had mother tongue German competency, I would not be allowed to participate in the AM101 clinical trial here in Germany (even though I live here and have official healthcare coverage). That's why I had to go through all the off-label "crap"...

The tinnitus clinical trial is UK based (for certain). There possibly is another clinical in the US (for hearing loss; not confirmed - at least not to me). The criteria for enrollment could well be different for those two (speculation on my part, of course).

The source "on the other side of the fence" has already told me he/she knows there will not be "enough seats" for everyone (no surprise there - this is a phase II trial ie. small numbers to demonstrate efficacy). But once enrollment is possible via the resource webpage, you should have a go at it.



You will have to wait and see, is the simple answer to that. But, I suspect that they will request something like the following:

1) Possible restrictions on how long you have had tinnitus ("possibly" - I don't know!) eg. enrollment may be restricted to candidates who have had tinnitus for up to 12 months (example only!!!).
2) No other on-going tinnitus treatments (eg. AM101 trial).
3) Medication free (or nearly so) - eg. no Trobalt in your system please...!

Again, the above is pure speculation on my part. You will probably be asked to submit a blood sample and a urine test. And possibly your medical file (from somewhere).

The person I have been in contact with has told me - as I already know - that this is a clinical trial, and there are strict procedures for inclusion/exclusion criteria. A clinical trial is not about "the patient" - it is about all the many future patients who potentially can benefit from the medication. The clinical trial itself could not care less about you. They only want people who fit the profile. Anyone on the borderline is just a nuisance to them.



I doubt it will get fast-tracked (I can't see the specific reason why it should ie. there is no threat to humanity or likewise). The person I have been in contact with has already confirmed to me that there is much work to done. Again, no surprise there since this is just the very beginning of phase II trial.



Regarding Flupirtine, I will provide an update on Monday or Tuesday after seeing my GP.

We discussed the fast track earlier or in another topic, but it's not black or white. I agree that we may not have a fast track like for a cancer drug, but early access to the drug can be done in many other ways (extentend trials, off trial distribution, etc...)

Also I think the medical criteria is not the only factor in the fast track equation, money and lobbying are also key and if the US gov can save a billion or 2 as well as help vets, they will probably consider the option.
Let's also not forget Autifony stakeholders are big corporations such as Pfizer and depending on their stocks they may want to push earlier a new disrupting product on the market, especially since the WHO has been confirming that T. is to become in the coming years a pharmaceutical el dorado. First arrived, first served.