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

[bill 112]

Clinical trials are conducted completely different in Ireland they are usually conducted on terminally ill patients with their permission of course i.e if a cancer patient is terminally ill they usually ask them if they would like to try an experimental drug which may or may not help them.They can easily see the drugs efficiancy and safety if the patient reports improvement in their symptoms and the doctor can back this up through the patients medical history.If the cancer progression has slowed or halted it clearly shows the drugs effiancy as all other treatments are stopped while they are trying the new drug.This is the best way to test new drugs as it gives them hope and a chance to beating cancer rather than waist time by giving it to people who dont need it they give it to the people who need it the most.

 

[Stina]

Clinical trials are conducted completely different in Ireland they are usually conducted on terminally ill patients with their permission of course i.e if a cancer patient is terminally ill they usually ask them if they would like to try an experimental drug which may or may not help them.They can easily see the drugs efficiancy and safety if the patient reports improvement in their symptoms and the doctor can back this up through the patients medical history.If the cancer progression has slowed or halted it clearly shows the drugs effiancy as all other treatments are stopped while they are trying the new drug.This is the best way to test new drugs as it gives them hope and a chance to beating cancer rather than waist time by giving it to people who dont need it they give it to the people who need it the most.

Yes but there are many cases in which people are not terminally ill Tinnitus is one of them, because you cant die from that. Therefore it is not possible to do trials on terminally ill tinnitus patients. With cancer its different.

 

[MikeA]

Stina: kudos for helping tip the balance recently toward sensible, informative posts in this thread. LOL

 

[t-man]

Therefore it is not possible to do trials on terminally ill tinnitus patients. With cancer its different.

Terminally ill cancer patients with tinnitus. I'm confident you can have both. I just happen to have multiple ailments. Maybe I'm unique.

Chemo is infamous for causing tinnitus.

 

[Stina]

Terminally ill cancer patients with tinnitus. I'm confident you can have both. I just happen to have multiple ailments. Maybe I'm unique.

Chemo is infamous for causing tinnitus.

In the example above the person who made the first post spoke about cancer treatments treatment trials for cancer patients. I think if one is about to die it would not be very ethical to ask them to participate in a non-cancer related trial (not to speak about the fact that they take a lot of meds and nobody knows what causes what). Its a lot easier and less painful for patients and their loved ones to choose patients who are not dying. The fact that the patient is soon leaving doesn't mean that they should be treated as a piece of meat without emotions available for experiments.
Also there are a lot of other aspects such as they take too much medications anyway and considering that terminally ill patients live maybe a couple months to half a year would make research difficult. These are all very small aspects though considering the ethical aspects.

 

[bill 112]

In the example above the person who made the first post spoke about cancer treatments treatment trials for cancer patients. I think if one is about to die it would not be very ethical to ask them to participate in a non-cancer related trial (not to speak about the fact that they take a lot of meds and nobody knows what causes what). Its a lot easier and less painful for patients and their loved ones to choose patients who are not dying. The fact that the patient is soon leaving doesn't mean that they should be treated as a piece of meat without emotions available for experiments.
Also there are a lot of other aspects such as they take too much medications anyway and considering that terminally ill patients live maybe a couple months to half a year would make research difficult. These are all very small aspects though considering the ethical aspects.

Sorry if I made it confusing and yes your right it would not be ethical to try drugs not related to their illness which they dont it would be monstrous to do such a thing.But my point was in Ireland they give new drugs to people who need it the most rather than pay some healthy individual to try it.Its not just cancer or terminal illness but other chronic conditions such as arthritis and fibermyralgia and as a result these drugs get to market in Ireland alot faster than usual once they have been approved which is great as it can help these people who desperately need it.Sorry if this is off topic

 

[Stina]

Sorry if I made it confusing and yes your right it would not be ethical to try drugs not related to their illness which they dont it would be monstrous to do such a thing.But my point was in Ireland they give new drugs to people who need it the most rather than pay some healthy individual to try it.Its not just cancer or terminal illness but other chronic conditions such as arthritis and fibermyralgia and as a result these drugs get to market in Ireland alot faster than usual once they have been approved which is great as it can help these people who desperately need it.Sorry if this is off topic

hmm yes maybe the trials are different then. although the reason why drugs are tested on normal patients in phase I is because they want to detect the side effects of the drug and that would be difficult to do if the person already has the drug. In phase II and III all drugs will be given to actual patients. How do they test the side effects then in Ireland??

 

[bill 112]

hmm yes maybe the trials are different then. although the reason why drugs are tested on normal patients in phase I is because they want to detect the side effects of the drug and that would be difficult to do if the person already has the drug. In phase II and III all drugs will be given to actual patients. How do they test the side effects then in Ireland??

Through medical history basically lets say an arthritis patient undergoes this trial of a new drug he/she will take this drug for a certain amount of time under medical supervision where they constantly monitor blood pressure,do regular blood tests and ask the patient if he/she has had any strange symtoms like night sweats,heart palpitations and so on which are all taken note of and monitored throughout the trial.Finally they are asked what improvements if any have they noticed during the trial which are all taken note of.Of course this is a placebo test so they know what theyve taken until the trial is completed.They basically test safety and efficiancy in one go.Irelands a small country so trying to find healthy volunteers to participate in a trial is next to impossible although I may add trials take part in Ireland very very rarely.Basically if Autifony conducted their trials here it would be done in half the time

 

[dan]

The trial took place in London.

http://www.nres.nhs.uk/researchsummaries/?entryid29=174756&p=2195

 

[Erlend]

The trial took place in London.

http://www.nres.nhs.uk/researchsummaries/?entryid29=174756&p=2195

Took place? It's over?

How long until they consider the drug safe and begin a trial for people who actually have T?

 

[Stina]

Took place? It's over?

How long until they consider the drug safe and begin a trial for people who actually have T?

They will have to give it out in a scientific journal (? Journal of NeuroScience, Id expect, given out weekly). However it takes time to gather the data acquiared from the study so it can take several months. They said they will start the trials this year, but I dont know when exactly.
Also, Phase II is also more about safety, not efficacy. Phase III will show efficacy.

 

[dan]

Yeah its over Erlend. I think somebody here emailed Dr.Large and got a response that phase 2 will start this year.
This tells me it was safe in phase 1.

 

[dan]

They will have to give it out in a scientific journal (? Journal of NeuroScience, Id expect, given out weekly). However it takes time to gather the data acquiared from the study so it can take several months. They said they will start the trials this year, but I dont know when exactly.
Also, Phase II is also more about safety, not efficacy. Phase III will show efficacy.

I don't think phase II is also about safety. They will be testing a proper dose on a small group of people. Also wasn't there 2 parts in phase II ? ie phase II and phase IIb.
Phase III is then repeated on a large scale.

 

[Stina]

I don't think phase II is also about safety. They will be testing a proper dose on a small group of people. Also wasn't there 2 parts in phase II ? ie phase II and phase IIb.
Phase III is then repeated on a large scale.

I think Phase IIa and b are for testing the dose, eg. which dose would be most efficient. Yes of course Phase II will show efficacy as well, but as they normally use a quite ssmall number of people, (under a 100) strong conclusions cant be drawn from it. At least thats what I understood from some knowledgeable people from the AM101 board. I dont have a medical education so I dont know the details.

 

[dan]

I think Phase IIa and b are for testing the dose, eg. which dose would be most efficient. Yes of course Phase II will show efficacy as well, but as they normally use a quite ssmall number of people, (under a 100) strong conclusions cant be drawn from it. At least thats what I understood from some knowledgeable people from the AM101 board. I dont have a medical education so I dont know the details.

Yes, I totally agree with this answer. You are still very intelligent, you should study medicine ;-)

 

[Robb]

i hate this phase bullshit it is time they seriously speed things up...!

 

[t-man]

i hate this phase bullshit it is time they seriously speed things up...!

The FDA and equivalent agencies need this time to find out if new drugs and treatments endangers profits for larger pharmaceutical companies current treatments and technologies are safe and effective.

 

[MikeA]

i hate this phase bullshit it is time they seriously speed things up...!

The only way to speed things up, that I can envision anyway, is for there to be more funding so that ever increasing numbers of researchers can investigate and bring to bear novel and well tested approaches to treat and/or cure this disease. Perhaps I am wrong.

 

[Stina]

The only way to speed things up, that I can envision anyway, is for there to be more funding so that ever increasing numbers of researchers can investigate and bring to bear novel and well tested approaches to treat and/or cure this disease. Perhaps I am wrong.

Im afraid so. I also think it might scientists who already have worked in a similar area, so finding them might not be so easy.

 

[benryu]

I am not sure if it was already posted but I found this presentation from autifony.
(date of the presentation: 10th of April 2014)
http://www.anglonordicbiotech.com/img/File/Comp Pres 2014/Autifony-session 1.pdf

Key learnings:
A few more details about how it works
The financial side of it

 

[Littlebailey]

Well I want autifony to be the winner in this sweepstakes. Am 101 seems to be all set on wanting to treat brand-new T sufferers within 3 months. While a very noble thing, I hope the mindset here isn't to cure T from here on out. And anybody who already has it, and is no longer 'acute', is S-O-L. That would really suck. Not to be a downer, but just saying.

I mean it would be a wonder drug breakthrough if something like AM 101 really did work, even if it was only for recent onset T, but it would only help cure people from the date of its release, and if you got T, and rushed to the hospital and got your treatment, you'd be cured, but everyone else who got it three months before that wouldn't get any relief. That would be awful. And yet T would still be considered to be cured. And in a huge way it would be.

Yikes! Besides, autifony seems like a more righteous and elegant sort of approach anyway.

 

[MikeA]

Well I want autifony to be the winner in this sweepstakes.

Likely that the processes involved in medicine and pharmaceutical research are just a bit more sophisticated than what you've described. Righteous and elegant?

 

[Littlebailey]

Likely that the processes involved in medicine and pharmaceutical research are just a bit more sophisticated than what you've described. Righteous and elegant?

Well, maybe that was a stupidly grandiose way to put it. I just like the idea of what they're doing with their research best, such as I understand it, which is a very much just an ignorant layman's. Whether it's actually an elegant approach or not, I guess I have no idea. But I'll stand by calling it righteous!

 

[Stina]

Well I want autifony to be the winner in this sweepstakes. Am 101 seems to be all set on wanting to treat brand-new T sufferers within 3 months. While a very noble thing, I hope the mindset here isn't to cure T from here on out. And anybody who already has it, and is no longer 'acute', is S-O-L. That would really suck. Not to be a downer, but just saying.

I mean it would be a wonder drug breakthrough if something like AM 101 really did work, even if it was only for recent onset T, but it would only help cure people from the date of its release, and if you got T, and rushed to the hospital and got your treatment, you'd be cured, but everyone else who got it three months before that wouldn't get any relief. That would be awful. And yet T would still be considered to be cured. And in a huge way it would be.

Yikes! Besides, autifony seems like a more righteous and elegant sort of approach anyway.

If you are willing to pay (and other sufferers as well of course) they will try to work smth out Considering the number of people having it the scientists would become richy rich rich

 

[MikeA]

If you are willing to pay (and other sufferers as well of course) they will try to work smth out Considering the number of people having it the scientists would become richy rich rich

Exactly. I see the lines between honest research done the right way and the snake oil salesmen becoming more blurred with each passing day. Sure hope that doesn't become a problem. Besides, there's instant relief for tinnitus just a click away:
http://www.prweb.com/releases/tinnitus-control/reviews/prweb11786881.htm

 

[benryu]

Only in NA (USA+Canada), if we consider the ratio from the presentation, 10% to 15% of the population is affected by T. at some point.
If you compare to how much cost similar treatment for chronic problems such as asthma, it's around $100 a month.
I believe pills are to be taken for a year at least, it's a potential of $1000 per patient in turn over.
The market could be then valued around 35,4 billion dollars. Considering the proportion of T. sufferer is increasing year after year (the WHO in health 2020 is expecting up to 25% of the population to be affected by T in 2020), plus if we also account the population increase, the market is to be worth around 63 billion dollars. (NA only)

Where there is money, there is always a solution.

 

[lapidus]

Only in NA (USA+Canada), if we consider the ratio from the presentation, 10% to 15% of the population is affected by T. at some point.
If you compare to how much cost similar treatment for chronic problems such as asthma, it's around $100 a month.
I believe pills are to be taken for a year at least, it's a potential of $1000 per patient in turn over.
The market could be then valued around 35,4 billion dollars. Considering the proportion of T. sufferer is increasing year after year (the WHO in health 2020 is expecting up to 25% of the population to be affected by T in 2020), plus if we also account the population increase, the market is to be worth around 63 billion dollars. (NA only)

Where there is money, there is always a solution.

Yes, and I think those 10-15% applies for the whole western world. In swedish studies they have also reached this conclusion and that the numbers will increase due to the "ipod-generation".

 

[Grace]

Only in NA (USA+Canada), if we consider the ratio from the presentation, 10% to 15% of the population is affected by T. at some point.
If you compare to how much cost similar treatment for chronic problems such as asthma, it's around $100 a month.
I believe pills are to be taken for a year at least, it's a potential of $1000 per patient in turn over.
The market could be then valued around 35,4 billion dollars. Considering the proportion of T. sufferer is increasing year after year (the WHO in health 2020 is expecting up to 25% of the population to be affected by T in 2020), plus if we also account the population increase, the market is to be worth around 63 billion dollars. (NA only)

Where there is money, there is always a solution.

Yup this virus is spreadin like masquito bites..scientists should be smart enough to know that statisics are just gonna
Go up and up.. That 25% will turn to
50 %.. Its the lifetime of the T! Solution time!!!!

 

[benryu]

@Grace it's not about scientists, it's about VCs & Pharma corporations, those are the people who decide what problem is worth being tackled (when it's expected to be financially viable). The good thing is that it works like an economic bubble once one is investing on a cure, all competitors follow just to make sure not to lose a competitive advantage. This is why we are seeing a burst of money since 2013 being invested in finding a cure for T.
Plus most health NGO are forecasting the problem to become major, it's a major problem for veteran, and the US gov is losing a shit lot of money because of T. So everyone is getting more & more concerned.

It's more than likely that we see a cure or at least a viable relief by 2016/2017. And more & more options will become available by 2020.
A point we also forget is that Japan is working super hard on a cure too as their demographic is changing. Indeed the amount of people above 50 is sky rocketting. Japan actually sells more diapers for old people than for babies. T. is a dominant issue for this +50 generation, and the market is massive.

Ironically, I am kind of happy that I had tinnitus before it becomes something easily curable, this shit helped me to build a f**** tough mindset without the danger of some other more serious diseases! haha

 

[jazz]

it's not about scientists, it's about VCs & Pharma corporations, those are the people who decide what problem is worth being tackled (when it's expected to be financially viable).

How true! It's all about the economic model for drug development in a for profit world.

On the plus side, drug companies love to develop "me too" drugs. With the success of AM 101 and hopefully of Autifony, the market will welcome many players--drawn from big pharma, biotech, and VC funders. These groups will work assiduously to cash in on such a large and lucrative market.