Autifony Therapeutics Phase I Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter Hudson
- Start date
Member
I called the UK tinnitus organisation (BTA) as they tend to work with any companies planning research where volunteers are needed. They said likely September for the Autifony Phase II; it will be on the BTA's website when they start recruiting.
oh ok yay.@Grace it depends on the doseIf the substance is right you just need a bigger dose
Well autifony themselves are presenting this drug as being for chronic patients, so I'd like to think they really mean it. And that the concept really does involve affecting /altering the fundamental mechanism, the physical mechanism if you will, that allows T to occur, ie the "source". Furthermore, that the cause of the T would possibly be immaterial. Whatever the cause of one's T, it would appear as if we all experience the same thing, more or less. And one might further think that the mechanism of delivery if you will, could only be the same one, quite possibly the potassium channels being targeted in this drug. Whatever the cause.
As far as so-called maladaptive plasticity goes, I thought that referred to the original reason anyone experiences T at all, as opposed to people with inner ear damage that don't experience T where we do. And that the plasticity that affects T sufferers happens earlier in the whole process, setting us up to hear the phantom ringing.
But the actual ringing occurs and is facilitated by way of those potassium channels, and so if you are able to block it there, at that point in the process, then you are able to quiet the ringing, almost irrespective of anything else.
Now that may be wishful, overly common-sense thinking, or just plain wrong, but that's how I read it. The faulty plasticity allows and encourages the generation of the ringing to start with, but the drug prevents it from following through, by disrupting it's delivery mechanism, the gated potassium channels. And so no more T.
Having said all that, I'm well aware I could be completely wrong in my minimal understanding of how this is supposed to work, and probably am.
As far as so-called maladaptive plasticity goes, I thought that referred to the original reason anyone experiences T at all, as opposed to people with inner ear damage that don't experience T where we do. And that the plasticity that affects T sufferers happens earlier in the whole process, setting us up to hear the phantom ringing.
But the actual ringing occurs and is facilitated by way of those potassium channels, and so if you are able to block it there, at that point in the process, then you are able to quiet the ringing, almost irrespective of anything else.
Now that may be wishful, overly common-sense thinking, or just plain wrong, but that's how I read it. The faulty plasticity allows and encourages the generation of the ringing to start with, but the drug prevents it from following through, by disrupting it's delivery mechanism, the gated potassium channels. And so no more T.
Having said all that, I'm well aware I could be completely wrong in my minimal understanding of how this is supposed to work, and probably am.
- Dec 24, 2013
- 933
- Tinnitus Since
- (1956) > 1980 > 2006 > 2012 > (2015)
- Cause of Tinnitus
- Ac. Trauma & Ac.Trauma + Meds.
Hey nills...thanks for this link you put up: http://www.medicalnewstoday.com/articles/270408.php
I looked this lady up on Google and found this, which I have thought for some time will be one of the biggest driving forces in pushing $$$ forward for a Tinnitus 'cure' (or significant help)...the US military! As we all know, the Pentagon has big clout and big bucks to spend, and the VA is getting the picture that Tinnitus and PTSD are "expensive" (sic). So, maybe there will be the big gorilla beating on this drum too.
Here's the link: http://veterans.house.gov/witness-testimony/susan-e-shore-phd
This lady Dr./Prof Susan Shore seems to be pretty prolific. There is a ton of stuff on her re Google and I will post another reference on the main forum page too.
Best, Zimichael
I looked this lady up on Google and found this, which I have thought for some time will be one of the biggest driving forces in pushing $$$ forward for a Tinnitus 'cure' (or significant help)...the US military! As we all know, the Pentagon has big clout and big bucks to spend, and the VA is getting the picture that Tinnitus and PTSD are "expensive" (sic). So, maybe there will be the big gorilla beating on this drum too.
Here's the link: http://veterans.house.gov/witness-testimony/susan-e-shore-phd
This lady Dr./Prof Susan Shore seems to be pretty prolific. There is a ton of stuff on her re Google and I will post another reference on the main forum page too.
Best, Zimichael
I am, and I guess I could put myself forward when the time comes. But I think stage 2 trials are about trying out different dosage levels aren't they? To see which is most effective. So I might wait until stage 3, hoping with fingers, toes and everything else crossed that there is stage 3 as from a selfish point of view would be more likely to get the optimum dose. Also, and here I show my pessimistic nature, what if it makes the tinnitus worse somehow? As far as we know, no human being with tinnitus has taken the drug yet and the rats couldn't tell us if, say, the original noise changed to something different.Are you from the UK and would you be able to participate?
Members of the Military, for example, could take it before going into action.
bill 112
Member
Agree with you Lilian and thats the harsh reality isnt it,that we really dont know how this will really pan out it might not work at all or it might decrease the T but leave patients with horrible side effects upon higher dosage we really dont know yet as the rat cant tell us a whole lot.Im the kind of really need to know person and thats why im trying to participate in stage2 trials.I have a lot of hope in this and I just need to know does it have any affect whatsoever,im so tired of having hope in something just to be disappointed when it doesnt work.We need light at the end of our tunnel and this is my light and I just hope whats at the other end of the tunnel is what im expecting it to be.
I really hope you get to do the trial and it works for you Bill. If it does, nick some extra tablets for us please
bill 112
Member
Haha I may do Lilian and become a little T drug dealerI really hope you get to do the trial and it works for you Bill. If it does, nick some extra tablets for us please
If the doctor conducting the trial turns his back for one second that bag of Autifony is coming with me
- May 8, 2012
- 1,601
- Tinnitus Since
- 04/15/2012 or earlier?
- Cause of Tinnitus
- Most likely hearing loss
Phase 2 is still early and just means if it passes after a couple years then on to phase 3 for a couple more years, then NDA and post market study and if all goes well on the market in 7+ years. Seems promising...I hope Autifony doesn't turn out to be Auti-phoney. I think if the US Gov would put real money behind research for T, there would be treatment much sooner. US Gov is going to pay out $1.5-2.0 Billion in T disability payments to in 2014. Can you imaging what just 10% of that would do for T research?
I really hope you get to do the trial and it works for you Bill. If it does, nick some extra tablets for us please
I guess participating in trials is always a risk. I think quite often stage II is divided into stage IIa and IIb, one for efficacy and the other for dosage.
I don't think it's any coincidence that the trial is being held in the UK. Drug licensing takes much longer in the US via the FDA. In the UK there are two licensing bodies; the EMA is the European agency for a pan-Europe launch, of which the UK would be part. The quickest route is generally via the MHRA, which is a UK only agency for initial licensing in the UK only that is very supportive of innovation. Hence their Early Access to Medicines Scheme:
Launched in April 2014. This scheme gives patients with unmet medical need (that's us folks!) access to drugs before they are licensed. Benefits to life science companies could include greater exposure to prescribers in the UK and the opportunity to collect real world data on the profile of the medicine. The Promising Innovative Medicines (PIM) designation provides an early indication that a product may be a possible candidate for the Early Access to Medicines Scheme.
They also say:
Licensing flexibilities are available to help speed up the licensing process to get medicines to market more quickly. MHRA can advise you (that's the drugs companies) how you can make use of these.
Note for future: I do a very good rate on Bed & Breakfast at my place
Sure, though their medicines research centre is in Italy. Also (encouragingly) Pfizer are the major investor so it seems good that they are clearly interested@Lilian123 could be but Autifony is a British company so that might be the actual reason as well
bill 112
Member
My cousin works for Pfizer here in Ireland and he was amazed when I told him that Pfizer had invested 8 million in Autifony.Now he has no idea what Autifony are or do but he said Pfizer were having slight financial difficulties in recent years they even shut down one of their biggest factories which was in Cork in Ireland and for them to throw an investment into a small pharma company of this size shows that they must really be onto something.When I told him that they are developing drugs to beat T he laughed and said well that would explain it.They obviously must have a real promising product because Pfizer and nearly every other pharma company know that there is millions to be made in this market.
I'm getting a bit off-topic here Bill, but expect you know Pfizer's US parent company is all over the news at the moment as they are trying to take over AstraZeneca, the UK drugs company, and the concern is that they will close down a lot of research and production in the UK, leading to job losses. So, I agree with you, they are only going to put their money where they think it has a possibility of a good return. That said, £8m to them is like about 10p to you and me!
bill 112
Member
Hi Rog sorry Im late responding to your message but Kimbo pretty much hit the nail on the head with his response.Its been well established that the T noise is manufactured in the brain no matter really what the cause seems to be.If you have an ear infection or have been exposed to high levels of noise this may disappear over a couple of days or even weeks.But when it doesnt disappear after lets say a couple of months the term chronic is used.Autifonys approach and hypothesis is that voltage gated ion channels which are essential for transmitting sound through the brain have become overactive in their nature whether its from a loss of hearing or something else really remains a bit of a mystery.Autifonys approach is in simple terms telling these channels to calm down and to try and return them to their pre-T resting state and thats what they hope to achieve with Aut00063.The drug is meant to target the auditory brain from the brainstem up thus stopping T at its root cause.Now thats all good in theory but true effectiveness in humans is yet to be established but I cant see any real reason why this product if successful wouldnt work for you also.
bill 112
Member
Exactly my point they are only going to put their money where they know theyll get good return on their investment after all they are a business and the only thing they are concerned about is making money.Yeah true 8m is like pennies to them but for them to invest cash like this into a small pharma company shows real promise and belief that Autifony are on to something.At the end of the day 8m is nothing to be sniffed at,its still a sizeable amount of investment.I just hope their investment pays off.
I hope they find a cure soon , have mines 1 month ago , feel like it came from my Thyroid med., being changed a few times, Thyroid went , then down, doc changed med. and my tinnitus started . I read on google , this can happen , hoping when my level is reached , I can go back to a normal life , hoping and praying for every boby ..God bless!
Except the ringing is caused by the middle ear, it is not an actual phantom sound. I have both subjective and objective tinnitus. The subjective is clearly in my head while the objective is a sound coming from my ear, I can actually hear the ringing coming from two different places. If the ringing is not actually over active neurons the drug will do nothing.
I think you can be evaluated for objective T. The doctor can somehow use an instrument to hear your objective T. I recall reading this somewhere. Have you been diagnosed with it?
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