Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

[Philemon]

I am simply approaching this from a logical perspective using comparisons (as I generally do). Whether or not screening should take place, I do not know, but I do know this much:

• Just about any country in the Western part of the world has seen restrictions on smoking in public and at work places (fair or not, I am not to judge). Now comes the point of logical inference: if legislative measures are brought forward to protect, say, office workers from 2nd hand smoke, then why not (also) protect unborn babies? Are office workers somehow more important?
• Screening is already used in many places: breathalyzer tests for motorists, drug tests in schools, drug tests at work places, drug testing for army recruits, etc. Now, people may think that such tests interferes with their personal freedom. That is of course a matter of personal opinion, but again, I do know this much: if we can - as a society - accept/tolerate screening for such a wide area of the population (e.g. schools, work, driving) then why not for a sub-set of society such as pregnant mothers? Again... just a logical inference here.

You already do. See 2nd bullet point, above.


Carbon monoxide screening has nothing to do with eugenism. Bringing forward "favourable genes" (i.e. desirable traits such as colour of hair) - that's eugenics (as opposed to ensuring the best possible health of existing genes - regardless of, say, colour of hair).

In addition, you might want to see this:

http://tobaccofreefutures.org/news/uk-experts-call-for-national-co-screening-for-all-mums-to-be/

Lastly, just to keep this thread a little "on-topic" in relation to tinnitus/hearing, I would like to mention that modern studies keep highlighting new ways that smoking affects unborn babies. Previously it was generally accepted that only seriously underweight babies (< 1750 grams) would have a chance of impaired hearing. However, it is now known that smoking during pregnancy leads to a 3-fold risk of mild hearing loss (regardless of weight of babies):

http://www.nvrc.org/2013/07/study-l...while-pregnant-to-hearing-loss-in-adolescents

Now... the above is just one area of health that smoking during pregnancy affects. There are many more. If you think it is reasonable that children should be born with defects to their hearing, and perhaps increased risk of developing tinnitus later on, that is of course your choice. But I think otherwise.

Lastly, here is a comparison photo of what happens to the movements of a fetus when a mother smokes:

View attachment 8401

Top series of photos: smoking mother
Bottom series: non-smoking mother

attheedgeofscience
30/OCT/2015.

Sorry to keep it off-topic but …


Of course I don't think it is reasonable that children should be born with defects to their hearing, nor do I think that there's no problem with pregnant women smoking, I'm just saying that the way you suggest (because you suggest things at least, even if in a subtle way) to fix that would by no mean an effective one (neither a desirable one). We need education and sensibilisation to make people understand the issues at stake and make them stop by themselves those kind of behavior … otherwise, you could have all the screening or any kind of authoritative and intrusive measures, people will always find a way to do such kind of bullshit … and if a government or political regime would take such kind of measures (screening of pregnant women), they would take the risk to open the way for more authoritative and intrusive measures regarding many other aspects of life, because when you start like that you never know where it would stop, and who would be legitimate to put the limits and where ? I'm sorry, but that's the principle of totalitarism, or at least it could lead to it.


And yes of course it has something to do with eugenism, at least in a broad sense or at least historically, guess which political regime initiated the first anti-smoking policies of modern era ? (and it was no coincidence, they did it with very clear eugenist considerations in mind) A regime that had a precise view of what should be the health status of their population and very authoritative way to ensure the best health status of their population (at least they thought that's what they were ensuring with their policies, but of course it's controversial).


Don't get me wrong, i'm not drawing any comparison with what you wrote, but we should just keep in mind that the way a society keep a control over people's behavior, and which kind of control we are ready to accept and/or to find socially legitimate or acceptable, is not only a matter of logic (as you claim you use to draw what are your own conclusions), but rather a political thing (in the true/substantial sense) such that there's not only one-logical-way-to-govern-society (which is a scary concept, leaving no room to political/democratic debates and decision making)

 

[Silvio Sabo]

I am simply approaching this from a logical perspective using comparisons (as I generally do). Whether or not screening should take place, I do not know, but I do know this much:

• Just about any country in the Western part of the world has seen restrictions on smoking in public and at work places (fair or not, I am not to judge). Now comes the point of logical inference: if legislative measures are brought forward to protect, say, office workers from 2nd hand smoke, then why not (also) protect unborn babies? Are office workers somehow more important?
• Screening is already used in many places: breathalyzer tests for motorists, drug tests in schools, drug tests at work places, drug testing for army recruits, etc. Now, people may think that such tests interferes with their personal freedom. That is of course a matter of personal opinion, but again, I do know this much: if we can - as a society - accept/tolerate screening for such a wide area of the population (e.g. schools, work, driving) then why not for a sub-set of society such as pregnant mothers? Again... just a logical inference here.

The thing with humans is that they aren't always logical and rational. From what I can read in your posts you are a highly logical person. And I understand that this might be difficult for someone that relies so much on logic and reason to comprehend.

BTW It's a bit funny that you mention pregnant women because there have been studies on this and it shows that estrogen (or at least high levels of estrogen) promotes irrational thinking and mood swings. Our hormones do effect how we think and act. Just ask anyone that has experienced depression. But that's also what makes us human. The fact that we aren't rational and that many of us often times make decisions based on feelings and not on logic. Once again I do understand if this is hard for some people to comprehend.

Now, your thoughts of condemning the whole of human race based on roughly 10% is a bit unfair. As I said previously it's not about that it's about progress. And we have progressed.

You mention that legislation has come in place in the western world to protect people from second hand smoking and you are absolutely right about that. But change takes time. Passing a law doesn't automatically change how people behave but it does indeed help. I'm not in any way covering for or taking side with those who smoke when they're pregnant. But ruling out our society and diminishing our accomplishments and progress based on how a fraction of us behave is unfair.

One must remember that we still are cavemen. Biologically we are no different that our ancestors from a few thousand years ago. There has been no noticeable biological evolution in the human race in that time. Our brains are just as big today as they were 10 000 years ago. This is why I don't agree with arguments like "It's 2015!" It's just a figure. We happened to start counting the years in the modern calendar 2015 years ago. And that's about it! Our society has been evolving much longer than that and hasn't reached it's peak yet. But we have come a long way from living in the caves and hunting Mammoths. Even though we biologically are still the same.

 

[monacco]

As I see here they started the phase 1

 

[Silvio Sabo]

As I see here they started the phase 1

View attachment 8426

I'm curious about OTO-4XX. If you go to the homepage of OTO-4XX under pipeline they have the following text:


"OTO-4XX

Otonomy has acquired the rights to multiple product candidates for our fourth development program, which will target age-related hearing loss, also known as presbycusis. There are 36 million adults in the U.S. who report hearing loss which we believe represents the largest market opportunity in the otology field. We are evaluating several different approaches to treat this condition, including repair of damaged ribbon synapses and regeneration of cochlear hair cells. Formulation and preclinical development is underway."


If they are regenerating hair cells and repairing ribbon synapses it could be useful in tinnitus as well.

 

[attheedgeofscience]

This is a pretty important milestone: first subjects to enroll in the phase-I study. Also some news regarding the timeline of the phase-I/II study.

http://globenewswire.com/news-relea...l-for-Tinnitus-Product-Candidate-OTO-311.html

 

[monacco]

his is a pretty important milestone: first subjects to enroll in the phase-I study. Also some news regarding the timeline of the phase-I/II study.

Why they have not mentioned inclusion and exclusion criteria? Does this mean it's for all tinnitus sufferers?

 

[attheedgeofscience]

Why they have not mentioned inclusion and exclusion criteria? Does this mean it's for all tinnitus sufferers?

Phase-I is a safety trial. Healthy volunteers only.

 

[amandine]

Do we know which group (acute, chronic) they are aiming for? Do we know anything? - like criteria for involvement - yet another injection into the ear treatment....

 

[just1morething]

Phase-I is a safety trial. Healthy volunteers only.

I wonder if they pay the "healthy volunteers" something? I would think they would have to. Who would want a hole punched in their eardrum? It was very painful when I had dexamethasone injected in my ear at Paparella Ear Institute, but he may have not numbed it up enough? The laser used at Shea wasn't bad though. Could be some of the volunteers have existing tubes in their ears for ETD or some other reason.

 

[Bart]

Is OTO-311 aimed at 'chronic' or 'accute' tinnitus ?

 

[attheedgeofscience]

Is OTO-311 aimed at 'chronic' or 'accute' tinnitus ?

To my knowledge, the information I obtained directly from Otonomy at the beginning of the year, remains the most newsworthy to date...

www.tinnitustalk.com/threads/otonomy-starting-phase-1-trial-in-2015-for-tinnitus.9017/#post-93572

 

[attheedgeofscience]

Those who wish can rate/share/comment on the FB-update from TinnitusTalk via the embedded link below.

 

[Gill Hayes]

This is the news we need after the Autifony debacle. Fingers crossed for better results for OTO-311 !

 

[billie48]

I am with you Gill. It is important for the medical and pharma field to continue to explore the world of tinnitus drugs to find some solution for T sufferers, many of whom find that such continued efforts give them hope that there will be an answer to their ailment in the future. In the mean time, we just have to keep positive and manage our reaction to T to minimize its damage to our life.

 

[attheedgeofscience]

Those who wish can rate/share/comment on the FB-update from TinnitusTalk via the embedded link below.

Members and visitors of TinnitusTalk, the reason these embedded links are placed as posts within important pharmaceutical clinical trial threads, as well as alerted to all members, is to get high ratings! Currently the rating is not high enough (30 ratings in total). We should be able to reach about 50-60 ratings for such an announcement!

More must be done!

attheedgeofscience
17/NOV/2015

 

[Marcuseva03]

News like this are better than no news at all yea. We can never be sure if there is really a cure within the next 10 yrs.

 

[PnL67]

Can it maybe have beneficial effects on hyperacusis?

 

[Codaz]

This is the news we need after the Autifony debacle. Fingers crossed for better results for OTO-311 !

I won't call Autifony a debacle. In some ways it learned the scientists a lot. If all knowledge is or will be published it gives new ground to do further research on.

 

[newarrior]

Mr. David Pearl



Thank you for your inquiry regarding Otonomy's clinical trials for our tinnitusproduct candidate, OTO-311. The FDA has cleared the company's Investigational New Drug application (IND) for OTO-311. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in a small number of volunteers who do not have tinnitus. We anticipate initiating a Phase 2 clinical trial and enrolling patients who do have a diagnosis of tinnitus in 2016, after successful completion of Phase 1 safety trial.


If you are interested, you can add your name to a database to receive future communications from the company related to clinical trials and program updates by registering here.


If you would like to receive alerts of news announcements from the company, you can register for alerts on the Otonomy website.


Finally, for information about other trials available for tinnitus patients, you can periodically check the clinicaltrials.gov website, searching for "tinnitus" to identify trials that are enrolling.

Additionally, I appreciate your inquiry about Otonomy's clinical trials for Sensorineural Hearing Loss. Currently, we are not conducting any clinical trials for patients with this diagnosis. However, we may in the future, so you can add your name to a database to receive future communications from Otonomy related to our development programs and clinical trials by registering here.

If you would like to receive alerts of news announcements from the company, you can register for alerts on the Otonomy website.


Finally, for information about other trials available for Sensorineural Hearing Loss patients, you can periodically check the clinicaltrials.gov website, searching for "Sensorineural" to identify trials that are enrolling.


Regards,

Dean Hakanson MD

 

[JohnK]

Would this trial be subject to the same 3 month limitation as the AM-101 trial?

 

[Bertman]

I imagine it would have similar limitations regarding time since onset as am-101. It seems that most companies would like to do that to start at least to get the ball rolling and see if it has efficacy, as medical treatments generally have a greater chance of working the sooner they are administered. Although who knows, maybe they will take people up to a year first and then go for chronic after that. It's a guessing game at this point.

 

[attheedgeofscience]

COMPANY PRESENTATION UPDATE (JANUARY 2016)

Otonomy Inc has just released a full company presentation incl. information on OTO-311 with efficacy comparisons to S-Ketamine (see slides 18-21 in the presentation deck).

Feel welcome to like and share on Facebook:

 

[Nucleo]

It seems OTO-311 is looking to be a direct competitor of AM-101, probably only effective in the early stages.

 

[liquefact]

It seems OTO-311 is looking to be a direct competitor of AM-101, probably only effective in the early stages.

Probably yes, as the mechanism is the same as AM101 (esketamine), it should prevent T in the early onset.

Regardless, the good thing about these two drugs are, they'll be an effective treatment of an unexpected increase of T because of barotrauma, noise exposure etc.

Even if the chronic sufferers will not be benefiting from these, they'll at least prevent further damage to cochlea.

 

[swc5150]

The second two bullet points in the presentation make me question if this is just for acute sufferers? I think maybe they see the profit potential in chronic cases? We'll see I suppose.

 

[ady]

This may be stupid question but could this injection be converted into oral medicine?

 

[Reinier]

This may be stupid question but could this injection be converted into oral medicine?

Stupid? I don't think so.
I understand that there is a blood/brain barrier that prevents the drug to reach the cochlea.
I believe the next step will be developing drugs that are able to get past this blood/brain barrier.
Another big step that will be.

 

[Jahhsoul]

Do you think the phase II will be done all over the world or just in USA?

 

[Reinier]

I couldn't find this on there website.
But I assume they will tell you if you send them an email.

Clinical Trials
For patients and health care providers who are interested in learning more about our ongoing clinical trials, please contact the Otonomy Clinical Trial Information group by phone at 1-844-OTO-NOMY (1-844-686-6669), or by email at ClinicalStudies@otonomy.com.

I do hope that "soon" more news will be available from Otonomy regarding OTO4XXX.
But likely this will be quite a long way away??

Quote:
OTO-4XX


Otonomy has acquired the rights to multiple product candidates for our fourth development program, which will target age-related hearing loss, also known as presbycusis. There are 36 million adults in the U.S. who report hearing loss which we believe represents the largest market opportunity in the otology field. We are evaluating several different approaches to treat this condition, including repair of damaged ribbon synapses and regeneration of cochlear hair cells. Formulation and preclinical development is underway.
End Quote.

 

[monacco]

So if really Gacyclidine is 5 times more potent than S-Ketamine, AM 101 is going to be dead, all that has been invested will be dropped in water... Bad news for Auris Medical. I prefer one injection more effective than three injections less effective.