Otonomy Acquires Assets and Patent Rights for Tinnitus Program

Discussion in 'Research News' started by Grant1, Nov 1, 2013.

tinnitus forum
    1. Grant1

      Grant1 Member

      I am unfamiliar with gacyclidine.

      Otonomy Acquires Assets and Patent Rights for Tinnitus Program - PR Newswire - The Sacramento Bee

      Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that it has completed the acquisition of certain assets and rights to intellectual property (IP) related to the use of gacyclidine for the treatment of tinnitus from an affiliate of NeuroSystec Corporation. Successful serial entrepreneur Alfred Mann founded NeuroSystec to develop a drug-device combination product that could provide sustained delivery of gacyclidine to the inner ear. Gacyclidine is a potent and selective antagonist of the N-Methyl-D-Aspartate (NMDA) receptor. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA antagonists as treatments for tinnitus. The company's third development program, 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.
       
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    2. James White
      Anime

      James White Member Benefactor

      Location:
      Toulouse, France
      Tinnitus Since:
      April 2013
      Cause of Tinnitus:
      Maybe loud music. Not sure.
      Hi Grant1,

      this is quite good news. NeuroSystec were kind of shut down for the last 2 years and we didn't know what happened to them. So we finally know who bought the assets.

      This doesn't mean it's a treatment yet, but i think NeuroSystec had a phase1 trial when they were alive.
       
    3. Markku
      Inspired

      Markku Director Staff Benefactor Hall of Fame Team Trobalt Team Tech Team Awareness Team Research

      Tinnitus Since:
      04/2010
      Cause of Tinnitus:
      Syringing
      Effects of extracochlear gacyclidine perfusion on tinnitus in humans: a case series.

      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.
       
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    4. Grant1

      Grant1 Member

      Thanks Markku. Very interesting.
       
    5. super07

      super07 Member

      Tinnitus Since:
      12/2012
    6. erik
      Breezy

      erik Manager Staff Benefactor

      Location:
      Washington State, USA
      Tinnitus Since:
      04/15/2012
      Cause of Tinnitus:
      Most likely hearing loss
      Not entirely new, but still a good possibility for treatment. Promising in Guinea pigs now on to humans....

      Otonomy, Inc.,
      a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that it has completed the acquisition of certain assets and rights to intellectual property (IP) related to the use of gacyclidine for the treatment of tinnitus from an affiliate of NeuroSystec Corporation. Successful serial entrepreneur Alfred Mann founded NeuroSystec to develop a drug-device combination product that could provide sustained delivery of gacyclidine to the inner ear. Gacyclidine is a potent and selective antagonist of the N-Methyl-D-Aspartate (NMDA) receptor. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA antagonists as treatments for tinnitus. The company's third development program, 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.

      Read more: Otonomy Acquires Assets and Patent Rights for Tinnitus Program -- SAN DIEGO, Oct. 31, 2013 /PRNewswire/ --

      Studies on Gacyclidine
      2007; Effects of Gacyclidine Extracochlear Perfusion on Tinnitus in Humans and Intracochlear Perfusion on ABR Thresholds in Guinea Pigs
      Effects of extracochlear gacyclidi... [Eur Arch Otorhinolaryngol. 2010] - PubMed - NCBI
      Journals on the Web
       
    7. Erlend
      Question it

      Erlend Member Benefactor

      Location:
      Scandinavia
      Tinnitus Since:
      05/2013
      What's best case scenario for this drug?
       
    8. This drug attacks the same pathway as AM-101 (NMDA receptor). The drug itself is probably not really superior, it is just another way to have a proprietary formula to attack the NMDA receptor - this is how drug companies make money. Ketamine (also an NMDA receptor antagonist) has been around since the early 20th century, but is off patent, so it makes no sense to even try to bring it to market as a new drug.

      I will say that Otonomy has a superior delivery method in that it is a gel that stays in place in the middle ear once it is injected. Auris Medical is a liquid that drains down the eustachian tube once it is injected, which is why I believe they will need to license a drug delivery system like mine in order to keep up with Otonomy. Anyway the Otonomy version is at least 5 years out. I suspect AM-101 will dominate the market for a couple of years until then.
       
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    9. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003

      Auris is using a gel formulation for their Phase 3 clinical trials. I believe they used a gel formulation of esketamine for a portion of their last Phase 2 clinical trial as well, but I can't remember.
       
    10. Champ
      Woot

      Champ Member Benefactor Team Tech

      Location:
      Boston, MA
      Tinnitus Since:
      1/2013
      Cause of Tinnitus:
      Acoustic trauma from headphones
      Dude, please stick around, your knowledge bombs have been really fun to read.
       
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    11. Auris uses a viscous substance, but Otonomy's formulation would be semi-solid once injected and would stay in the middle ear for days, whereas Auris' formulation will eventually leak down the eustachian tube once the patient sits up. That's why they have the patients lie on their side for a while when they inject AM-101.

      One known problem with both of these formulations is that the amount of drug reaching the inner ear falls off exponentially with time. The reason I started my company is that the optimal way to deliver drug to the cochlea is continuously over days. Alec Salt is the God of inner ear drug delivery and he has made computer models that simulate drug delivery to the ear. Basically you can't reach the top of the cochlea (where low frequency hearing occurs) if you don't have continuous delivery over days to weeks. This is a problem for people with a Meniere's type of hearing loss and tinnitus like me, because all of us have damage at the top of the cochlea. I guarantee you that the people in the AM-101 study do not have low frequency tinnitus or Meniere's symptoms.

      So the gels may be a "good enough" solution for these tinnitus drugs (AM-101 and gancyclidine) for now, however once they start delivering neurotrophic, gene therapy, or need coverage of the top of the cochlea, they are going to pump driven delivery, and I have invented a system that does this in a minimally invasive way.
       
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    12. Don't worry I'm sticking around. There are plenty more bombs to come!
       
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    13. jazz
      No Mood

      jazz Member Benefactor

      Location:
      US
      Tinnitus Since:
      8/2012
      Cause of Tinnitus:
      eardrum rupture from virus; barotrauma from ETD
      On Friday, Otonomy filed with the Nasdaq for an IPO. It will be listed under the name OTIC. This is great news for us. Every biotech success is important for securing venture capital for tinnitus and related ear disorders.

      Here is an excerpt from a recent article:

      San Diego biotech Otonomy filed Friday to raise up to $86 million in an initial public offering, just a few days after releasing positive Phase 3 data for its ear drug AuriPro.

      AuriPro was tested on children from 6 months to 17 years old undergoing ear tube placement surgery. The drug is a sustained-exposure formulation of the antibiotic ciprofloxacin. It's intended to reduce complications after the procedure. Success in the two Phase 3 trials was measured by the proportion of treatment failures. That's defined as the presence of drainage or the need for"rescue" therapy with other antibiotics reserved for more difficult cases.

      Otonomy raised $49 million from venture capital investors this spring. In September, the company raised $45.9 million.

      The company's prospectus said Otonomy plans to list under Nasdaq under the ticker OTIC.

      As of March 31, Otonomy had $31.1 million of cash on hand and $7.0 million available in credit, according to the prospectus. The company had 31 full-time employees. The company estimates that more than 50 million people in the U.S. are affected by ear disorders, and about 20 million seek treatment for common conditions such as ear infections, balance disorders, tinnitus and hearing loss, according to the prospectus.

      ...

      Besides AuriPro, the company's other drugs in development include OTO-104, a sustained-exposure steroid for inner ear disorders, including Ménière’s disease, the ailment that had afflicted Avalon's Lichter. Ménière’s disease causes symptoms including vertigo, tinnitus and fluctuating hearing loss.

      Another drug, OTO-311, is a sustained-exposure formulation of gacyclidine, used for tinnitus, or ringing in the ears. [emphasis added]
      Reference:
       
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    14. T-Bach

      T-Bach Guest

      Good morning! I have some BREAKING NEWS. There is a company in San Diego, California called Otonomy (founded in 2008). They bought up numerous patents from a man named Alfred Mann, who is well-known for his research into tinnitus. Otonomy has developed a drug for tinnitus which they are presently calling OTO-311, in their clinical trials. The drug is Gacyclidine, and it is an NMDA receptor antagonist, which means it has the same action as the drug that Auris Medical has developed. The drug dampens the body's response to tinnitus, by calming down the nerve endings responsible for it. Otonomy's drug is also injected into the eardrum, but their treatment only involves one injection, not three. They say this is because their drug is in a "sustained-exposure formulation." 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. These studies will be conducted across the U.S.A., and perhaps elsewhere. You will have to contact them to find out what other countries they will also be in. I highly recommend that you get involved in this Phase 2 trial.

      Both Otonomy and Auris Medical went public this past summer, and obviously, they are in competition with each other. This is good news for everyone in the world who has tinnitus. The more drug treatments, the better!

      Another very important aspect of this study coming up in 2015 by Otonomy is this....THEY DO NOT CARE HOW LONG YOU HAVE HAD YOUR TINNITUS. Anyone can participate. I spoke to one of their researchers directly (on the phone) who told me this. This is fantastic news for everyone! You can send them an email at: clinicalstudies@Otonomy.com. Ask them to put your name and email address on the list of people to contact next year, when they are getting ready to launch the study. This is a Phase 2 trial, which means that, when it starts, the drug would have already completed the Phase 1 trial, which proved it was SAFE. In Phase 2 trials (and in Phase 3 trials), they are trying to prove that it is EFFECTIVE. So there is nothing to worry about really, in a Phase 2 or Phase 3 trial. You can also visit their website: http://www.otonomy.com

      Please share this post all over this forum, and everywhere else you can!
       
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    15. Grace
      No Mood

      Grace Member

      Tinnitus Since:
      11/14/2013
      I would be more excited, but to me auris medical didnt really prove there drug has tons of potential. So if otonomy is gonna be similar to them, then im still keeping my bets on autifony.
       
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    16. T-Bach

      T-Bach Guest

      WHAT? Auris Medical proved in their Phase 2 trial that, for most people, their treatment lowered the loudness of the tinnitus significantly. They DID prove that it works for most people. Their Phase 3 trial is going on right now. I'm in it. I just got the injections. They take awhile to work, and I am waiting. But since it's a trial, I may have gotten a placebo. If I got the placebo, I'll find out in December, and then they will give me the drug for sure. You can bet that I will be jumping up and down, excited to get it!! I have full faith in Auris Medical, and their drug. 100%. I also believe in Dr. Thomas Meyer, President and CEO of Auris Medical, 100%. So I do not understand your comment. But...Autifony is conducting Phase 2 trials in great Britain right now. You can contact them at: info@autifony.com Maybe you can enroll.
       
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    17. Zimichael

      Zimichael Member Benefactor

      Location:
      N. California
      Tinnitus Since:
      (1956) > 1980 > 2006 > 2012 > (2015)
      Cause of Tinnitus:
      Ac. Trauma & Ac.Trauma + Meds.
      Well this is such good news that I did a bit of snooping for our old: "Can we invest in our own pain for some gain for a change?" thing...It was "interesting" so far.

      I see that Otonomy has the same address as Organovo, which is a company I have been aware of for a while http://www.organovo.com/company/about-organovo as they do 3-D bio-printing:

      At Organovo, we design and create functional human tissues using our proprietary three-dimensional bioprinting technology. Our goal is to build living human tissues that are proven to function like native tissues. With reproducible 3D tissues that accurately represent human biology, we are enabling ground-breaking therapies by:…etc.

      Which is indeed in the bio-tech field.

      However, I find it a bit odd that there is no replication of the Executive Officers or Board of Directors between/within Otonomy and Organovo???...Like are they in the same building??? Is Organovo fronting them???

      I mean it sounds great to have long term T version of AM-101 so I was thrilled enough to look into more detail and the stock (NASDAQ = OTIC). Just puzzles me as to this ‘locational anomaly’. Read the address for yourself on both websites. [See for yourself...Street View with address clearly visible provided below].

      Where is Otonomy's corporate headquarters?

      6275 Nancy Ridge Drive, Suite 100 San Diego, CA 92121Phone: (858) 242-5200


      Best, Zimichael


      2014-10-06_0921.png
       
    18. T-Bach

      T-Bach Guest

      Well, I just called Otonomy. Their phone number is 858-242-5200. They confirmed that their address is, in fact, 6275 Nancy Ridge. They also confirmed that they are in Suite 100 of this building, and that Organovo is also located in that building. Why you are trying to make Otonomy look suspicious? Otonomy is an extremely legitimate company, and they are doing extremely important work. They filed for an IPO this summer, and I also have a copy of their Preliminary Prospectus. I have attached a copy of the cover of their Prospectus. Their address is clearly indicated inside, on page 6. Would you like me to copy that page and upload it as well?


      Otonomy Prospectus cover.jpg
       
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    19. T-Bach

      T-Bach Guest

      Hello Zimichael...I just went to Google Maps. If you will click over just a bit, and take a look at the side of the building located at 6275 Nancy Ridge, you can see the front door for Otonomy, with their name above it. Below is a picture. Your mystery is solved!


      Otonomy's front door on side of building.jpg
       
    20. t-man
      Suicidal

      t-man Member

      Tinnitus Since:
      2009
      Not really excited about this. Auris didn't exactly have great results. If given the opportunity you might as well try it. Who knows?
       
    21. T-Bach

      T-Bach Guest

      I don't understand your comment. Auris had GREAT results. I read them. Most of the people who got the injections reported that the loudness of their tinnitus was much less, and some people reported that their tinnitus was gone. To me, that is GREAT. Just getting the loudness down to a level where you hardly notice it (or don't notice it) is the goal. I would strongly encourage anyone who is within 3 months of onset to contact Auris Medical immediately and participate in their Phase 3 trial. The injections don't hurt because they numb the eardrum, and the treatment is not dangerous. It can't hurt you--it can only help you. Why would anyone with tinnitus NOT try to reduce the loudness of their tinnitus? Look, I am deathly afraid of needles, and I am deathly afraid of medical stuff, but I am so focused on getting rid of this darn tinnitus that I am willing to try anything! Plus, the GREAT results that Auris had in their Phase 2 trial convinced me to sign up for the Phase 3 trial right away. I don't know how anyone can pass up this opportunity. Their drug will probably not be on the market until 2016 (or 2017). Why wait for that when you can get it now?
       
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    22. Grace
      No Mood

      Grace Member

      Tinnitus Since:
      11/14/2013
      Your right, you may have gotten the placebo.. Any everyone else on here must have too cause i dont remember reading anything that made me go WOW yet, thats all. Ofcorse i welcome any tinnitus drug to show efficiancy and hope it does. I wanna read someone like hudson that has chronic T, or dr nagler that has severe T to take am101 and cut the noise in half and if it does to tons like them then ill go WOW.
       
    23. Zimichael

      Zimichael Member Benefactor

      Location:
      N. California
      Tinnitus Since:
      (1956) > 1980 > 2006 > 2012 > (2015)
      Cause of Tinnitus:
      Ac. Trauma & Ac.Trauma + Meds.
      T-Bach... Cool! Thanks as saved me a call to find out what the scoop was. I was not trying to be smart-arse "Kiljoy" but indeed decades of promised 'Tinnitus cures' seems to awaken my inner skeptic. Then our incredible ATEOS cyber-sleuth on the forum has influenced my tendency to "dig a little deeper" so to speak. What I came up with just seemed "odd" that's all...as indeed I would be interested in investing in a company that has a legit product to help us/me after nearly six decades of waiting. As I said, some gain for the pain would be a nice change! (And who would know better about credibility and efficacy than us lot!).

      Hopefully this thread grows into a genuine success story. Seeing as they are in sunny CA, their proximity is a helluva lot closer for me than the UK and trying to fit into Autifony's 'impossible' (but explained - so no need to rehash) criteria.
      Please keep us all posted if you have more inside line on this company and progress.

      Thanks much, Zimichael
       
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    24. Robb
      Question it

      Robb Member Benefactor

      Location:
      Germany
      Tinnitus Since:
      09/2013
      T - Bach when you act so positively you might like to scoop up a bit of realism, so as @Zimichael said i do not wish to ruin your happy mood.

      I slowly tend to believe that autifony will have the solution with the most impact, oral drugs so does trobalt etc show. All needle stuff is only effective when done within time to eliminate the cochlear aspect.
       
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    25. T-Bach

      T-Bach Guest

      Our culture has been so trained to "just take a pill" to solve any problem we have. The television has done that, and it is so sad. Your comment that "needle stuff is only effective when done within time" is, quite frankly, not accurate. Otonomy states that their drug, which is administered by an injection into the middle ear through the eardrum (and then soaks down into the inner ear and onto the cochlea), works, no matter how long someone has had tinnitus, and their Phase 2 study is open to everyone with tinnitus, regardless of the date of their tinnitus onset.

      Yet, you are right that I am positive! Yes! Thank you! And I am going to stay positive, my friend! In my world, being positive IS being realistic!
       
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    26. Grace
      No Mood

      Grace Member

      Tinnitus Since:
      11/14/2013
      Yup like robb said.. Basically what there finding out is T is in the brain not the cochlear.. Or only when its accute so autifonys pill and pills that compete with autifony will be the big winner in my opinnion. There some brain interactions goin on and no needle is gonna solve that, but a pill will.--- but hey will find out and if im wrong then good!!! :)
       
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    27. T-Bach

      T-Bach Guest


      I do understand where you are coming from. And you have had tinnitus a lot longer than I have, so I respect your perspective greatly. I have the feeling (woman's intuition maybe) that we are on the cusp of several new medical treatments for tinnitus. I really believe that we will see them soon. Yes, I am a positive person by nature. But I really believe this.
      But the fact remains...the tiny hairs in the cochlea ARE damaged/destroyed. And...Otonomy's new drug (an injection of drug that goes onto the cochlea) is supposed to even work on people who have had tinnitus for years. So it's clear that fixing the problem in the cochlea is important. The people who are working on these things are much smarter than you and I, and I seriously doubt that they would have invested so many millions of dollars into nothing. I have not yet researched the drug action of Autifony's drug, so I don't know how it exactly works. I will try to find out.
       
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    28. Robb
      Question it

      Robb Member Benefactor

      Location:
      Germany
      Tinnitus Since:
      09/2013
      T-Bach slow down and try to discuss instead of let your opinion dominate that this is the mighty solution. Substances which otonomy has have been already tested in such fashion. I do hope that Otonomy will be successfull
       
    29. T-Bach

      T-Bach Guest

      I was providing information, not opinion.
       
    30. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      @T-Bach Your contribution to the forum is greatly appreciated. I did not know that Otonomy is going to be starting a trial in the near future. Thank you for the information. It seems like you know a good deal about them. We encourage debate here at TT, but we will not tolerate aggressive behavior on this forum. Your opinions and contributions are most definitely welcome.
       
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