Otonomy Acquires Assets and Patent Rights for Tinnitus Program

Jaaaeeeeeeeeeez Eloieeeeez.....Where is @benryu ??? We could use his famous quote quite regularly about 'leave the forum for a few days and there's a war on'. Ha, ha...Really I can't take this too seriously as we humans are a goofy lot. Plus I believe (before you locked your profile) T-Bach, that you only joined this site on Friday?...So not a lot of street cred yet in terms of people here getting to know you. We have had all kinds of stuff posted that ends up being "slaughtered" a lot more thoroughly than what just happened above.

So yes, it would be good if you just took a breath, looked at what has been said, and realize that you can offer something not seemingly available...to me anyway. That is, I see no evidence of Otonomy's Phase II trial on their website. So you must have some inside track info, and that is always useful with anything that is dealing with the complex esoterica of tinnitus and it's treatment.

Up to you I guess. But by nature one can get pretty "antsy" with T and all the ways it can be "cured" that have a habit of imploding. Like I said, I was promised over five DECADES ago that a cure was just around the corner. The guys (yeah, all "guys" back then -maybe one reason things did not get too far ) in the white coats were going to fix everything!!! That didn't really pan out too good.

Hopefully Otonomy's claim that their stuff works on long term T will be substantiated... Indeed, time will tell. It will not be a matter of positivity, or relativity, or anythingivity. If it WORKS we will know of it here on this forum in light speed!

Best, Zimichael

 

@Zimichael I did a search on the clinical trial site and could not find T-Bach's referenced Phase 1 tinnitus trial.

I do hope Otonomy's drug helps people with chronic tinnitus. But my understanding is that the window to help cochlear cells recover from auditory damage is limited. After a while, there are no cells left in the cochlea to quiet. They return to a damaged, but normal, state. A new normal, I guess. Of course, the brain does not return to normal since it is now missing sounds from the dead and damaged cochlear regions.

Here is the link to the government clinical trials site:

https://clinicaltrials.gov/ct2/results?term=otonomy&Search=Search​

 

It's great another similar treatment is being worked on towards the same mechanism as AM-101. Just because "something similar was done before" doesn't make Otonomy's research any less important or useful. They're offering an alternative solution for people that might not respond well to Eskatime, or might have other complications due to it; furthermore, they're negating the need for repeat injections like AM-101 requires, which is ideal for people with structural eardrum issues (some people's ear drums don't heal, they don't want to end up with Swiss cheese eardrums) Gacyclidine might also be an NMDA antagonist like AM-101, but the molecular structure is quite different. There are over 30 different kinds of dissociative NMDA antagonists, and they're all different in their own right, it's necessary to look for a variety of effective solutions pertaining to this mechanism. The more companies working towards T cures the merrier. There will be millions of future T sufferers that will be glad that they will have some options, and somewhere along the way these different individual companies will come across other novel treatments for all sorts of different T sufferers.

 

@jss
@Robb

To be fair, there's also no evidence from either company which suggests that excess glutamate feedback loop is not possible on a chronic basis. It's completely possible that some T sufferers might actually have slow deteriorating chochlea due to excess glutamate secretion over a period of 6+ months in addition to the brain "memorizing" the sound, in which case should be treated regardless of T. The whole 3 month acute tinnitus mark created for AM-101 study is entirely arbitrary to fit their objective of the study. Now I don't know where T-Bach got this information from, but it's still possible from a hypothetical standpoint that that excess glutamate secretion can be prolonged for many months and perhaps even years due to LTP and the deafferentation of the nerve cells. I think T-Bach's point is that halting further deterioration of the cochlea would surely help, and Otonomy is willing to give that a shot, hence the "no limit of onset" criteria.

 

Umm, did they do a study on mice? Did they fix mouse tinnitus ? - 'cause that's what you need to proceed to phase 1.

 

Ehhhh
Why are these trials never in Australia.
Everything is always in America, the nexus of the universe.

 

That's because Otonomy acquired the full rights and assets from NeuroSystec after the clinical phase I trial had been carried out (I believe I mentioned this briefly in the financial evaluations I provided in the Auris Medical IPO thread - which was created by member @Cor a couple of months ago...)

http://www.ata.org/clinical-trials-neurosystec

So if you search NeuroSystec, you should find what you are looking for...

http://www.clinicaltrials.gov/ct2/results?term=NeuroSystec&Search=Search

Here were some/all of the inclusion criteria from that specific phase I trial (I have highlighted one of the significant inclusion criteria; as can be seen, there may be "relaxed" criteria when it comes to onset of tinnitus, but there were strict criteria in terms of hearing loss (not many people on this forum would qualify)). Of course inclusion/exclusion criteria may be different for the phase II trial, but I would still caution people about being too optimistic in terms of enrollment before they see the actual criteria in writing...

Criteria

Inclusion Criteria:

• Patients able to provide voluntary consent.
• Severe tinnitus in one ear that began no more than ten years ago.
• Ear to be treated must be deaf or have profound hearing loss.
• Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
• Subject must have intact cochlear nerve on the ear to be treated.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.

Exclusion Criteria:

• Current diagnosis of bilateral tinnitus.
• Current diagnosis or history of pancreatitis.
• Females that are pregnant or lactating.
• Use of investigational drugs within the previous 30 days.
• History of drug dependency or other substance abuse.

 

Had a call from Ontonomy yesterday and they are going to get back to me with the trial info.

Will update when/if anything happens.

Best, Zimichael

 

@Grace

I would never encourage or discourage anyone from participating in the trial. I will only state my experiences of the trial process and how it effected me.

As an AM-101 trial participant, I have had a reduction of loudness and annoyance. I don't know if I received the drug or the placebo as it's a blind trial. I'd like to believe I received the drug as my tinnitus started changing along the timeline they told me I should expect. I am much happier with the volume/annoyance of my tinnitus than I was before the trial. I am currently scheduled for the follow up open label trial where I hope it completely eliminates my tinnitus.

 

I am not in anyway discouraging anyone from participating, im only giving my opinnion on the subject that the am 101 was specifically only for those with accute T, and that the other member ^ there was acting like it would work for anyone, and until proven my opinnion is that i dont have alot of faith in it for longtime chronics. Anyone that wants to participate i would strongly encourage them cause why not? It can only help or not work at all but at least they tried. Glad you got amazing results, and hope it keeps up!

 

Please read the posts of ResonanceCeo on this page: https://www.tinnitustalk.com/threads/am-101-tactt1-results-released.1994/page-22#post-39453
He is a scientist who also has tinnitus and is currently working in the field. He clearly states that in the 2nd phase there were no significant differences between the control group and the people who received the actual drug - only a trend towards positive outcome because they had so little patients involved. He does not say that it did not work for anyone or that it is not going to work, simply that the results are yet quite unclear.
Please remember that I am not saying this to bring you down or tell you not to get involved in the trial, Im simply stating out facts from a reliable source.

 

I'd like to apologize for the way my post read. My stating that I'd never discourage or encourage anyone to take part in the trial was my disclaimer for my own posting as I'd not want to influence anyone by what I wrote.

 

I am glad to hear that news from you!!!!

Its good to know there can be more possible treatments for T.

I have read that am101 has had very good results so far and with this oto311 can be another good thing for T sufferers.
We should trust in god and then people working on this thing.

Some people say we should not get our hopes high but i think only HOPE is our strength.

I dont know when the meds can be available but if anyone has any guesses please enlighten for Am101 and oto311.

 

where are the studys of otonomy? (locations)

 

@jazz ...or anyone actually. Here it is again, and I am getting confused about this "issue" seeing as we have all hoped that AUT00063 (Autifony's Kv3 drug) would get hitched to a rocket instead of a Model T, in terms of time frame.

This from http://www.marketwatch.com/story/ot...-safety-study-2014-10-09?reflink=MW_news_stmp

About OTO-104
OTO-104, which has been granted Fast Track designation by the FDA, is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of Ménière's disease and other inner ear conditions.

Then the classic "Fast Track" definition:

The FDA Fast Track Designation is a designation of the United StatesFood and Drug Administration(FDA) that facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.

So, the simple conclusion is, that Tinnitus is not a "serious or life threatening condition". Am I right???

Well, excuse my French...BUT WHY THE FUCK NOT??????!!!!!!

Did we not just have a suicide posted a few weeks ago? Do we not have "serious" problems with tinnitus for non habituable T people? Does it not mean we have an astonishing $$$ figure for tinnitus treatment at the VA? Etc., etc., etc....You all know the score here, so what is going on???

~ Does it mean we just don't have a vociferous enough lobby?
~ Does it mean we need a "Tinnitus March" in DC with everyone wearing Bose NC headphones or earmuffs?
~ Does it mean the ATA is just a totally useless organization and has not stumped for us hard enough?
~ Does it mean that the Audiologists and ENTs are in some kind of denial of our reality?
~ Does it mean that conferences about T are just too wussy and not taken seriously?

What does it mean??? I'm buggered if I know!

"Dazed and confused"... Zimichael

 

Severe tinnitus is a serious condition. Menieres disease is a serious medical condition.

Menieres disease is potentially "10" times more devastating than severe tinnitus. Dr. Wilden - whom I am met four times last summer - also treats people with Menieres disease. Some of his patients are so sick with vertigo when they arrive at his clinic that they vomit on the floor. Some have attacks of vertigo that last several days where they can't even get out of bed. That's what living with Menieres disease can be like. And on top of that, people with Menieres disease have both hearing loss and tinnitus also. Not fun...

I am neither defending nor attacking the FDA's decision (as opposed to not granting eg. tinnitus treatments a fast track). I am simply pointing out the medical difference between the two conditions.

 

"Alles klar"...Thanks. Does not sound like fun at all...though some of those descriptions do remind me of how my "treatments" to help my T over the years have made me feel (and when I would get a new ramp up in volume). My doc knows the 'vomiting on his floor one'...Poor guy.

Oh well...more sighs I guess! Zimichael

 

Please do, will watch this thread.

 

I am still waiting. Did a repeat call to Otonomy and they got back to me yesterday saying: "Normally our trial agent is very good about getting back to people so we will contact them again."

Thus at his point no clue still of what the "requirements" are for their supposed Phase II.

Best, Zimichael

 

I am STILL still waiting!!!

Every week i call up Otonomy and say: "Hey these guys running your Phase II trial still have not contacted me!" And I get the same semi dung about how good they usually are in contacting people right away and so on.

I will keep pestering them, but maybe they should take some lessons from the AM-101 folks at Auris....Oh, and also no reply from SciFluor re SF0034 either.

Best, Zimichael

 

Hey I'm getting somewhere!
However, have promised to 'keep it to myself' for a few days while they get their act together. I said that Auris (AM-101) was kicking Otonomy's rear in terms of "customer/patient support" so if they wanted to compete they should do a lot better than me needing to call four times in four weeks and still get no response!
I will wait and see what their "fast track" response to me now activates and report back soon.
(P.S. Still zero from SciFluor though on SF0034).
Best, Zimichael

 

OK...this is a mess!

The supposed 'clinical trials' people that are maybe doing this follow-up for Otonomy know nothing about any trial. Thus on 'call five' back to Otonomy, I may now get a more direct answer as have covered all the bases and got nowhere, so 'some people' are going to get contacted directly concerning my road to nowhere...We will see. *[There is still nothing coming up if I do a search of Otonomy, OTO-104, or OTO-311 on the NIH trials website].

Also, in the initial post that started this thread the inference ("They are currently in Phase 1 clinical studies right now, and they are planning on having Phase 2 studies start, in the second quarter of 2015.") may be confusing with OTO-104 with OTO-311 in relation to Phase II, as this below is from Otonomy's website:

The goal of our OTO-311 program is to develop a sustained-exposure formulation of gacyclidine that will provide a full course of treatment from a single IT injection. We expect to file an Investigational New Drug application, or IND, with the FDA in order to initiate clinical development during 2015.

I will post more when I find out for sure what is going on...if I do!

Zimichael

 

Hearing stuff like this is one of the few things that helps me cope with my tinnitus, learning about others who have conditions far worse than mine(fibromyalgia,ALS,ClusterHeadaches) give me some perspective and makes things seem atleast not as bad as they could be. Doesn't stop the screaming in my head but oh well.

 

I don't get it, you just posted that the FDA did grant Otonomy fast track designation.

 

Dan, the "fast track" was for the Menieres drug...the OTO-104, not the tinnitus drug OTO-311 which is the Tinnitus drug.

Also I have a definitive update on the original basis of this thread... THE INFORMATION ON THE SUBJECT LINE OF THIS THREAD IS INCORRECT! The tinnitus trial is NOT in process and the first step will be Phase I safety studies on a very small sample of people (20 to 30) in 2015.
That is where the TINNITUS DRUG is at c/o Otonomy. And that is from the woman in charge of drug at Otonomy who called me. Also, that they will update any info that becomes relevant on either dug or the trials on their website.

For those interested, here is the link for the Menieres trails c/o of general search at the ClinicalTrials.gov website:
https://clinicaltrials.gov/ct2/results?term=Otonomy+OTO-104&Search=Search

So for tinnitus and Otonomy, this thread should probably quit right here until late 2015 or so, as it has been a wild goose chase.

Best, Zimichael

 

Im not being funny or rude. But i will say this. We need these drugs now. Now, not tomorrow, not next year, not in 10 years. Now....we need it now on a fastrack like Ebola drugs which are now on fastrack.

Comon medical researchers, scientists, nnnnow!!!!

 

Looks like all the trials are for people with Miniere's disease.

 

hi

I am hoping someone here can help me locate the name of the study being conducted in the ?states. I thought it was called 0tt331 but I must have it wrong. its meant to be similar to the am101 trial but will include all t onsets? the name of the drug started with a g.....duh!

 

Here it is...

...Gacyclidine

https://www.tinnitustalk.com/threads/otonomy-starting-phase-2-trial-in-2015-for-tinnitus-—-no-limit-on-your-onset.6365/

 

Why does there website state it is not even in phase 1 yet?

http://www.otonomy.com/pipeline/product-candidates/