Autifony Therapeutics Phase I Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter Hudson
- Start date
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@Stina , from what I've Googled about phases in other illnesses, phase 1 determines the safest dosage and the highest dose a person can tolerate (maximum tolerated dose) and so on.
Safety was already determined in phase 1, so.......
Phase II trials test whether a drug or other treatment is effective against [insert illness here] based on the dose and schedule determined to be safe in a phase I trial.
Read more: http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/clinical-trials/phases-of-clinical-trials/?region=on#ixzz33YLXSlOo
So I guess phase 2 tests for efficacy without taking into account the placebo effect.
The placebo effect is much stronger in tinnitus than cancer. There's no placebo effect in cancer- its either cured or its not (?) ... So if they test 100 patients with Autifony and all of them get better by placebo, then phase 3 trials will certainly show that....well you get the idea...
Safety was already determined in phase 1, so.......
Phase II trials test whether a drug or other treatment is effective against [insert illness here] based on the dose and schedule determined to be safe in a phase I trial.
Read more: http://www.cancer.ca/en/cancer-information/diagnosis-and-treatment/clinical-trials/phases-of-clinical-trials/?region=on#ixzz33YLXSlOo
So I guess phase 2 tests for efficacy without taking into account the placebo effect.
The placebo effect is much stronger in tinnitus than cancer. There's no placebo effect in cancer- its either cured or its not (?) ... So if they test 100 patients with Autifony and all of them get better by placebo, then phase 3 trials will certainly show that....well you get the idea...
I do think a placebo effect won`t last and the real drug if it works will. Attention can do strange things with perception, that is way judging T is hard. But judging silence is very easy.
Here's a brief explanation of clinical trial phases from Wikipedia:
Here's another link to a more detailed explanation from a UK site:
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases 0, 1, 2, and 3, it will usually be approved by the national regulatory authority for use in the general population.
- Phase 0: Pharmacodynamics and Pharmacokinetics
- Phase 1: Screening for safety
- Phase 2: Establishing the efficacy of the drug, usually against a placebo
- Phase 3: Final confirmation of safety and efficacy
- Phase 4: Sentry studies during sales
Each phase has a different purpose and helps scientists answer a different question:
Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug are given to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).[24]
In Phase 1 trials, researchers test an experimental drug or treatment in a small group of people (20–80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the experimental treatment is given to a larger group of people (100–300) to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
In Phase 4 trials, postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive preclinical studies.
Phase 0 trials are the first-in-human trials. Single subtherapeutic doses of the study drug are given to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacodynamics (what the drug does to the body) and pharmacokinetics (what the body does to the drugs).[24]
In Phase 1 trials, researchers test an experimental drug or treatment in a small group of people (20–80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the experimental treatment is given to a larger group of people (100–300) to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely.
In Phase 4 trials, postmarketing studies delineate additional information, including the treatment's risks, benefits, and optimal use.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive preclinical studies.
Here's another link to a more detailed explanation from a UK site:
Yes, this is true. You might also enjoy the following pdf that offers an explanation for clinical trial terminology. See http://www.lau.edu.lb/irb/forms/clinical_trials_terminology_glossary.pdf. You should look specifically at "phases of clinical trials" for more detailed information.
bill 112
Member
Either way we need to keep hope alive,I was blown away yesterday by extremely exciting news yesterday that researchers believe they may have a cure for cancer.They specifically speak about Melanoma and are curently conducting a clinical trial involving 7000 patients in Ireland and the U.K I believe and they are calling it the miracle drug.The expected survival rate was between 20-40% without this new revolutionary treatment and so far the survival rate is 98% thanks to this new treatment.The reason this treatment made Irish headlines is because an Irish man received the treatment with doctors giving him possibly months to live at best.After agreeing to go with the trial all of his tumours disappeared and he is currently in remission and doctors believe he is cured i.e there is no sign of his cancer.It was after this powerful news that I gained alot of hope in the T and H field,like cancer research they try and try again until as of yesterday they finally got the results and the breakthrough they were looking for,and this will hopefully be the case in this research field.All of us hope that Autifony will be that incredible exciting breakthrough that were all hopeing for but even if its not we just have to wait a little longer for our day to come.Anyone interested in this article visit Irish daily stars website to read this story.
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
Here is way how it is possible to approve medication based for neurological illness or psychological before even end of fase 2, you bear in mind they do all phases but as medicine (AUTifony has shown safe on all dosages) they may push for faster approval. As you see all depends on effectiveness of drug , safety, and type, so it can be approved spring 2015. You can read they work on also medication on schizophrenia and simmular as those are also considered thalamus disaritmic medication so they can help where no other meds help.
Woohoooo!!!!thats really fuckin exciting!!!!!! Cancer needs to gooooo!!! And T but your right our time will comeeee
They have updated their own website, under the 'Pipeline' section with this; I know we knew it already but they have only just officially added this:
Autifony's lead programme AUT00063 has successfully completed Phase I clinical trials, and Phase IIa studies are being planned for age related hearing loss (in the US) and for tinnitus (in the UK), to start later in 2014.
Participation in clinical trials:
Further information on these trials will become available shortly.
Autifony's lead programme AUT00063 has successfully completed Phase I clinical trials, and Phase IIa studies are being planned for age related hearing loss (in the US) and for tinnitus (in the UK), to start later in 2014.
Participation in clinical trials:
Further information on these trials will become available shortly.
bill 112
Member
Its just really exciting times,it appears the medical community are really on a verge of a breakthrough in treatments for currently uncurable conditions.The cancer breakthrough really lifted my expectations in medicine,firstly because I lost my brother to cancer and I dont want anyone in this world to go through that horrible disease and that cancer is the holy grail if you will of medical research,and for a cure arising for it is a great step forward for mankind.It just shows what these researchers are capable of when money and passion are present,they can accomplish anything.Just need to keep high hopes for Autifony and to be prepared if it doesnt pan out the way we expectand if it doesnt they will just have to keep trying until they finally get it right.
I wonder how they'll define "age related hearing loss"? I'm a little under 40, but my ENT diagnosed me with hearing loss, and I did not have an acoustic trauma event. I've noticed several times that I have what audiologists sometimes call "cocktail party syndrome", where I can't understand speech in a noisy room. As I read it, that's exactly what AUT00063 is targeting.
I
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im sorry about your bro.. Ive lost some family members to cancer also.. Mostly lung. Its horrible.. But your right its a huge step forward even if there able to treat one type of cancer then theres hope for all others to eventually be cured also. And it seems that might be the case with T, that autifony will be able to help some.. Hope it helps all types of T! But if not then they will figure something else out for other types. This drug could also help them out research wise and figure out whats missing, and then develop other drugs as you said that are even better! But first great step towards chronic T! And who knows hell it could be the final step if it works wonders anythings possible. It could cure some and have a gigantic reduction like 70 percent for others! Lets hopee!
))
bill 112
Member
Thats weird I have that too,apparently my hearing is perfect,no dips at any frequency but I can barely understand a word anyone is saying in noisy environments,its like the backround noise over powers what theyre saying.Didnt know they had a term for it.
Well, perhaps I should have added, "when other people don't have a problem". I think that's why the term is "cocktail party syndrome" rather than "wild kegger syndrome", which would suggest something else entirely!
What if 1 Autifony tablet would cost $1000 and you would need 80 tablets to be cure, like with the hep C cure...
bill 112
Member
bill 112
Member
Okay somebody help clear this up for me,this drug is suppose to calm overactivity in the auditory brainstem by targeting voltage gated potassium ion channels an essential part of auditory conduction.Now if this is successful how does it actually work,will it work for loudness H and distortion.They speak about fragile x syndrome but fail to really mention H in their publications.Secondly any idea if this is taken as lets say like an antibiotic,for about 2-4 weeks and then your finished or is it a life time thing?
Maybe we dont know this information yet.. When they did the 30 and 60 mg on the large rats it said that there T was abolished up to 6 monthes or something so my guess would be we would have to take it for quite a while unless its a one time thing and done idk cause rats are smaller then us? Just a guess though so who knows. Could we email them and ask if the drug could potentially help with H also?
All i can contribute is that regardless which drug they develop the process of misfiring neurons must be breached and controlled, streamlined how you like to call it.
If autofony makes an impact I think it will speed up habituation and take the edge of very disturbed brains which have a large field of misfiring neurons.
Same why AM-101 can be so important is just because they can contribute in giving a long lasting effect which is to a certain degree noticeable
If autofony makes an impact I think it will speed up habituation and take the edge of very disturbed brains which have a large field of misfiring neurons.
Same why AM-101 can be so important is just because they can contribute in giving a long lasting effect which is to a certain degree noticeable
I think both drugs aim to treat different groups of tinnitus patients, actually. I can't believe that an agent like AUT00063 will be side effect free, so I am guessing a prescribing doctor would recommend a patient do the AM-101 treatment first, if their tinnitus is acute, and then pursue other avenues like this if their tinnitus is resistant to treatment and persists. Of course this is all speculation and I'm assuming both of these drugs will meet the criteria for approval.
If misfiring neurons were to get under control by say autifony, wouldnt that quiet the T? Ofcorse no one knows yet but if not completly quiet then the ones with severe T could bring theres down to say mild. they created the drug for the purpose of quieting T not just habutating right?
You are right. With H i mean u can skip the first hard months new T sufferers have and indeed than hopefully enjoy a cure..
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