Otonomy Acquires Assets and Patent Rights for Tinnitus Program

http://investors.otonomy.com/phoenix.zhtml?c=234082&p=RssLanding&cat=news&id=1989052

Obtained rights to preclinical and clinical data for OTO-311: In November, the company announced an exclusive licensing agreement with Ipsen through which Otonomy acquired rights to utilize Ipsen's gacyclidine clinical and nonclinical data in the development and registration of OTO-311, a sustained-exposure formulation of gacyclidine, in development for the treatment of tinnitus.

 

Eur Arch Otorhinolaryngol. 2010 May;267(5):691-9. doi: 10.1007/s00405-009-1126-1. Epub 2009 Oct 22.
Effects of extracochlear gacyclidine perfusion on tinnitus in humans: a case series.
Wenzel GI1, Warnecke A, Stöver T, Lenarz T.
Author information
Abstract
Gacyclidine, a non-competitive NMDA receptor antagonist, is a phencyclidine derivative with neuroprotective properties. It has been previously safely administered intravenously to acute traumatic brain-injured patients. Experiments in guinea pigs have shown that local administration of gacyclidine to the cochlea can suppress salicylate-induced tinnitus. Thus, we thought that patients with therapy-resistant sensorineural tinnitus might benefit from a local therapy with gacyclidine. As a compassionate treatment, we administered aqueous gacyclidine solution via a Durect RWmuCath(TM) into the round window niche in six patients with unilateral deafness associated with tinnitus. The response of each patient to the drug treatment was given a numerical value by the use of a visual analogue scale (VAS) on a scale of 0-10 for tinnitus intensity, where 0 represented no tinnitus and 10 represented unbearable tinnitus-intensity or -annoyance (subjective). After constant perfusion of gacyclidine for 40-63 h, four out of six patients experienced a temporary relief from their tinnitus. No serious side effects were recorded in any of the cases. Gacyclidine might present a potent drug for the suppression of sensorineural tinnitus in humans and therefore should be considered for future double-blinded, placebo-controlled clinical trials. For lasting effective treatment, controlled intracochlear and long-term delivery of the drug seems to be necessary. Further studies investigating the toxicological effects of gacyclidine intracochlear perfusion as well as different dosages and therapy durations are under way to ensure the safety of the drug for long-term human use and warrant clinical trials.

 

Hope, hope and more hope...

 

http://globenewswire.com/news-relea...al-Trial-of-OTO-104-in-Meniere-s-Disease.html

 

I have previously weighed in on this development.

I contacted Otonomy last week for an update in terms of their pipeline progress. I find it confusing that the acquired assets from Neuro Systec of OTO-311 is listed as being pre-clinical on their website...

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



...when in fact this is a thread about an upcoming phase-II trial! Additionally confusing is the fact that the initial trial Neuro Systec apparently conducted can be found listed as "terminated":

http://www.clinicaltrials.gov/ct2/show/NCT00957788?term=NeuroSystec&rank=1

So why would it still be in the pre-clinical stage...?

Anyway... as mentioned, I contacted Otonomy and specifically mentioned this confusion "in public" - and with a link to this website - but they have not responded (yet)...

 

@attheedgeofscience ATEOS...Good luck hearing back from them in a timely manner. Took me a lot of repeat calls.

Yeah it is kind of a confusing mess with what is going on here, though for sure (I think!?) Otonomy's OTO-311 is very much "pre-clinical" and that the safety studies of Phase I will only begin somewhere around mid 2015. That info was directly from the woman who is heading up the project itself - in San Francisco, not Otonomy's HQ people down in southern California...I am on her contact list to let me know when "something is happening".

It's kinda weird to me that Auris, who seems so much more organized, has seen it's stock price (EARS) plunge lately, yet Otonomy, who seem 'questionable' in comparison has seen its stock (OTIC) keep on going up. It even did a 15% one day jump a few days ago at beginning of December.

Oh well... Zimichael

 

I must admit that even myself - as a well versed financial analyst - am I having just a little bit of trouble following the continuation of information coming from Otonomy Inc (compared with the announcements made last year at this time). Whatever the story is, here is some pretty recent information (but the details are tricky to really make sense of I feel; hate it...)

Source: http://www.genengnews.com/gen-news-highlights/otonomy-nabs-ipsen-s-gacyclidine-data-to-support-tinnitus-candidate/81250567/

 

Since the information about OTO-311 is quite limited, I have gone through the financial sources (as I did with the AM-102 thread), and below is what I was able to find. All of it is relevant for the interested reader, but the most important parts are in black. The information comes from several different sources (hence the breaks indicated by ...).

 

Good snooping as usual ATEOS... However, I'm not sure where the hell this leaves us with Otonomy. I don't have vast amounts of confidence in anything moving at light speed. Again...
I guess next step "contact" could be mid 2015.
Best, Zimichael

 

Any update on this. The company is still trading at 33 dollars on the market per share. Too bad for me i didn't get in on the ground floor. the following is from Etrade:

52 - Week Range15.19 - 40.45
8/19/14 - 12/16/14

Otonomy, Inc. is a clinical-stage biopharmaceutical company. The Company focused on the development and commercialization of therapeutics for the treatment of diseases and disorders of the ear. The Company's lead product candidate, AuriPro, is a sustained-exposure antibiotic for which it has completed two identical Phase III clinical trials in 532 pediatric patients with middle ear effusion, or fluid, at the time of tympanostomy tube placement (TTP), surgery. Its second product candidate, OTO-104, is a sustained-exposure steroid that is in a Phase 2b clinical trial for patients with Meniere's disease. The Company has global commercialization rights to its product candidates. The Company has developed a formulation technology that provides sustained drug exposure in the middle or inner ear from a single local administration. Its technology utilizes a thermosensitive polymer, which transitions from a liquid to a gel at body temperature.

 

Yeah, and it's kind of a shame that poor old Auris (ticker = EARS) is getting so trashed as they are a helluva lot more transparent and forthcoming than Otonomy! *[See my dealings with Otonomy in that particular thread!]
https://www.tinnitustalk.com/thread...5-for-tinnitus-—-no-limit-on-your-onset.6365/

best, Zimichael

 

@Zimichael auris trashed ? where ?

 

Sorry...was talking stock prices! Basically down 50% since September... Ticker for Auris Medical = EARS.

Z.

 

Agreed.

 

Hi,

Just discovered this great forum. Although new here, I'm a Tinnitus sufferer of 14 years.

I can understand both the optimistic and the skeptic comments here, because both sides are me on different days!

When my Tinnitus started back i 2001, there was next to NOTHING of clinically relevant research. I remember thinking back then that Tinnitus seemed like a total mystery and a cure seemed 200 years away. Searching the internet for information just made me pessimistic and depressed.

Discovering now for the first time that there are several different companies competing to make a drug is for me really great news! It's like travelling 200 years in 14 years. Even if these trial drugs actually turn out to be ineffective, for me it's still GREAT news. It means the field is closing in on a real breakthrough (from patient perspective).

I also can understand people being skeptic whether a cure will be available in our lifetime, arguing that Tinnitus is a complicated symtom with different triggers, mechanisms and so on. But let me argue that this is fairly common in the history of medicine. Many diseases that today can be cured, seemed too complex and mysterious to be cured until the point when a treatment became available.

Let me just give a couple of quick examples. Both Insulin and Antibiotics for medical purpose seemed extremely complicated and little understood, even after being tested on the first patients. Scientists where in both fierce competition and disagreement, with some being pessimistic and other being optimistic. Do a quick research on the history of these drugs and you'll see what I mean.

Thank you all for keeping this forum active. And thank you for sharing information and opinions.

 

Agree; I felt the same during 2007. Back then there was little to nothing out there on T. There is definitely more interest in tinnitus from big pharma and biotech. The amount of publications on T and hearing loss are increasing. Interest in T is only going to increase more with the slew of kids that will develop T due to MP3 and iPods.

 

I found this article where they say that there already have been done trials with the Tinnitus OTO 311 compound ... read it and understand for yourself what they try to say ...

http://www.businesswire.com/news/ho...s-gacyclidine-data-Ipsen-support#.VKxG6YfcsXw

About the agreement

Under the terms of the agreement, Otonomy will have an exclusive license to use Ipsen’s clinical and non-clinical gacyclidine data to support worldwide development and regulatory filings for OTO-311. These data include non-clinical studies which supported Ipsen’s initiation of clinical studies for systemic administration of gacyclidine, and clinical data from several Phase 1 and Phase 2 clinical trials conducted by Ipsen. In total, more than 300 patients were treated with systemic gacyclidine as a potential neuroprotectant in various neurologic trauma indications. Financial terms of the agreement were not disclosed.

About gacyclidine

Gacyclidine is a potent and selective antagonist of the NMDA receptor. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA receptor antagonists as a potential treatment for tinnitus. OTO-311 utilizes Otonomy’s proprietary drug delivery technology to achieve sustained exposure of gacyclidine in the inner ear from a single intratympanic (IT) injection.

About Tinnitus

Tinnitus is the medical term for hearing noise when there is no outside source of the sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. The American Tinnitus Association1 reports that approximately 16 million patients in the United States have tinnitus symptoms severe enough to seek medical attention, and about two million patients cannot function on a normal day-to-day basis. Furthermore, the United States Department of Defense reports that tinnitus accounts for the most prevalent service-connected disability among veterans and that the costs of service-related tinnitus are estimated to exceed $2 billion2. While the most common cause of tinnitus is exposure to loud noise, a number of other factors can be involved including heart or blood vessel problems, hormonal changes in women, ear and sinus infections, certain medications and thyroid problems. People with severe tinnitus may have trouble hearing, working, and sleeping. At this time, there is no cure for tinnitus and there are no FDA-approved drugs for treating this debilitating condition.

About Otonomy

Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic injection. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Ménière's disease. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For additional information, please visit www.otonomy.com.

 

I have an update to share regarding the main compound of the drug of OTO-311, Gacyclidine.

I am a patient of an ENT surgery clinic that performs highly specialized surgeries. I had a meeting yesterday with one of the doctors there - the same one who was meant to have treated me with off-trial AM-101 back in May (but which did not go through in the end as Auris Medical would not release the study drug for an off-trial procedure). The reason I went to see him was because it some time ago came to my attention that Gacyclidine has also been used in an experimental 6 patient study in Germany:

And so the surgeon and I sat down and had a first impression discussion about it (the doctor was honest with me and said he had not heard about it before; I appreciate his honesty). The procedure above may - on the surface - seem like a regular IT injection as is the case with AM-101. But there is at least one important difference: Gacyclidine was in the above study delivered past the eardrum and directly into the membrane of the round window of the inner ear. This is important to recognize because it means that the procedure is potentially somewhat more risky. The reason is that if the membrane to the inner ear is damaged and the perilympathic liquid inside the cochlea leaks, the patient will become deaf (which is the reason why deaf patients with tinnitus were selected for the study - ie. "they had nothing to lose" if it went wrong). It is unclear to me (and the doctor) if there is a difference between the "Hannover study" and the upcoming clinical trial of OTO-311. The compound is the same, but it is unclear if the procedure is also the same.

The surgeon is someone who is licensed to partake in clinical trials and is generally forward leaning in terms of trying "new things". However, because the procedure is risky he would need his manager's approval. They also need to apply formally to become part of the study. He promised me feedback by the end of the week. However... as I was waiting to pay my bill at the reception, he had already called his manager and gotten his approval for the procedure (on the spot). They now therefore need to go through the differences (if any) between the Hannover study and OTO-311, and apply to become part of the study (or obtain the drug for non-study purposes). It is therefore slightly unclear where this will end up (as there is no guarantee that this will happen - as with AM-101). He suggested we catch up in three months time where he would have an answer.

As I was leaving the clinic, the doctor said to me "I know there is a lot of problems with tinnitus these days. We need to do something".

And with that, I have (once again) brought to the Internet the kind of information that your local GP would definitely not know about.

attheedgeofscience
08/JAN/2015.

 

I am starting to think that if T ever gets cured it will be because of you @attheedgeofscience

 

Well... he is at the edge of science

 

Thank you so much for the update and the info, @attheedgeofscience.

I have to say: I would not risk deafness for an experimental tinnitus treatment. It would be pretty horrible to be able to hear nothing but your T. But perhaps new delivery methods will be found. Even if things are moving slower than we all would like for tinnitus treatments, at least something is going on.

 

Thanks attheedgeofscience. Your proving to be the source for Tinnitus Today and your keeping all of us sufferers that much more hopeful. pLease keep it up.

 

Thanks edge for this information regarding OTO, maybe the thread title could be changed as it's a bit misleading now ?

 

Noted. When the trial starts, I suggest a new thread is created (possibly).

The thread title is a problem; so is much of the content of some of the posts, unfortunately. That's why I tried to get some facts from the people behind Otonomy. However, if the original poster really did speak with a researcher, then the information carries a certain amount of weight. I therefore suggest we leave everything "as is" for the moment.

 

A small update.

The intervention I described earlier on in this thread will not take place. As with the AM-101 non-study drug the ENT surgeon requested on my behalf last year from Auris Medical, the OTO-311 drug request was also declined to be released for non-study purposes. Below the exact message that my doctor received from Otonomy.

The information is actually already two months old, but I have not released it until now (for other reasons). Over the past year, I have been a (frequent) patient at the first class ENT surgery clinic, Acquaklinik, in Germany (headed by Prof. Strauß). As my journey into experimental ENT procedures have now come to an end, I would like to thank the ENT surgeons there for their forward leaning attitude and competence.

A few images from the Acquaklinik surgery deck (which looks more like NASA's flight control deck ):

 

Has it helped you over the past year and did you have surgery there and if so what kind of surgery did u have?
So it is over for you now and are you now T free? hopefully yes