Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

Discussion in 'Research News' started by attheedgeofscience, Jan 15, 2015.

    1. Casper

      Casper Member Benefactor

      Tinnitus Since:
      01/2017
      Cause of Tinnitus:
      Loud music at concert
      I think @NatureHiker was referring to the chairman and co-founder, Jay Lichter. Please correct me if I'm wrong.

      Taken from this link (emphasis mine):
      "In 2008, Jay Lichter, Ph.D., a partner at Avalon Ventures and biotechnology industry veteran, experienced his first severe attack of vertigo. While driving, he became severely disoriented and had to pull to the side of the road. After multiple doctor visits, he was diagnosed with Ménière’s disease and quickly experienced the limitations of available treatments. With his physician, Jeffrey Harris, M.D., Ph.D., chief of the division of otolaryngology-head and neck surgery at the University of California, San Diego, and several other experts in the field of otology, Dr. Lichter founded Otonomy to bring new treatment options to patients with otic (ear) disorders."
       
    2. NatureHiker
      Angelic

      NatureHiker Member

    3. RODRIGO

      RODRIGO Member

      Location:
      Valencia (Spain)
      Tinnitus Since:
      05/2013
      So I understand this is the first farmaceutical trial to improve the chronic tinnitus target in the last years...:)
       
    4. AliceW

      AliceW Member

      Location:
      France
      Tinnitus Since:
      02/2017
      Cause of Tinnitus:
      Acoustic trauma - loud noise
      Is this treatment given for chronic tinnitus ?(more than 6months ?Am101 was only for recent tinnitus :( )
      Not for recent one ? Are you sure ?
      I wrote to this company I would like to try it in the phase 2 of clinical trials... But I'm french and I don't know if they can include me.... And they answered me that they didn't know yet what criteria of tinnitus include for the study... (Sorry for my approximated english)
       
    5. Dave111
      Transparent

      Dave111 Member

      Location:
      Nederland
      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Makeing music in band and headphone on to long.
      This trial is for everybody with T.
       
    6. Dave111
      Transparent

      Dave111 Member

      Location:
      Nederland
      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Makeing music in band and headphone on to long.
      OTO-311 = Gacyclidine

      AM-101 = S-Ketamine (Esketamine)
       
    7. Michael Larsen
      Surfing

      Michael Larsen Member

      Tinnitus Since:
      2000
      Cause of Tinnitus:
      Noice
      OTO-311 is a so-called NMDA receptor antagonist - though differentiated from AM-101
      Esketamine is a "non-competitive NMDA antagonist" whereas Gacyclidine is one
      "Un-competitive blocker NMDA antagonist". They therefore have both the same pharmacological target, but work in a slightly different way.

      We must therefore assume that both AM-101 and OTO-311 are geared towards
      Acute inner ear tinnitus



       
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    8. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      Does anyome know if OTO-311 clinical trials will be run only in USA or in Europe as well?
       
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    9. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      I don't know, but I would expect them to.

      They have been trialing OTO-104 in GB, BE, DE and US. They have trialed OTO-201 in the US and CA.

      Hopefully, for OTO-311 they will at least do a remote trial in GB. I would hope so! Even though I would probably not be able to benefit from it. They should do it across a few places in Europe.
       
    10. Samir
      Obedient

      Samir Manager Staff Benefactor

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      This is what I got from Dean Hakanson, MD, Chief Medical Officer at Otonomy Inc.:

      "Thank you for your inquiry regarding Otonomy’s clinical trials for our tinnitus product 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. Timing for initiating a Phase 2 trial for OTO-311 in patients with tinnitus is scheduled for the end of this year. We do not have any other details regarding the protocol that can be shared as of todays date."
       
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