Denver Man Gets Gene Therapy to Restore Hearing

Discussion in 'Research News' started by Asian, Dec 16, 2014.

    1. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      Nice info ATEOS. Do we know how long it takes for the results to show? Will he wait for ever? Will he do it again for the other ear? What about other participants?
       
    2. rsmcfar

      rsmcfar Member

      Tinnitus Since:
      02/28/2014
      My recollection is the time range for improvement in the animal model was 3-5 weeks. The clinical trial info is here: https://clinicaltrials.gov/ct2/show/NCT02132130
      As I read this, the trial is with three people consecutively at the lowest amount. If this is safe, then they increase the dosage on groups of 12 until they find the maximum tolerable dose.

      Thanks to everyone on the thread who reached out to Mr. Gerk.
       
    3. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
      10 Years
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      It's probably too early to say, but the best case expectations from Novartis/Genvec is an increase of 10dB in hearing.
      So it's an experimental trial. It's still a success if the carrier (the taxi) can successfully transport the medication to the inner ear.

      If there is no harm and a minimal enhancement in hearing or balance, it would be a huge success for research and further therapies.

      Greets Tom
       
    4. rsmcfar

      rsmcfar Member

      Tinnitus Since:
      02/28/2014
      But they also stated, that this therapy also hided in the labs of Novartis and that they
      might did improve something. If there won't no harm to the patients, they already
      stated it as a success...
       
    5. rsmcfar

      rsmcfar Member

      Tinnitus Since:
      02/28/2014
      Sorry . . . Tom,

      Can you clarify the above statement?
       
    6. spingee
      Wtf

      spingee Member

      i think they experimented on recently deafned animals as opposed long time Gerk onset, thaht could be reason
       
    7. attheedgeofscience
      No Mood

      attheedgeofscience Member Mighty Benefactor Hall of Fame

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      I believe - just from memory of the subject - that natural regeneration of hair cells in fish and birds takes approximately 30 days. Hearing threshold starts at about 25db in those cases (not 0db as with pristine hair cells).

      I don't think he will get the other ear done, but I can check. Another member of Team Trobalt had an hour long conversation with one of the scientists from GenVec, last week. I can refer to him for questions and/or I will probably be contacting the same scientist to learn a bit more myself. However, hearing restoration is not the primary topic of Team Trobalt.

      The following slide indicates the potency of the intervention in terms of restoring hearing in guinea pigs (the restoration is therefore more potent than an improvement of 10db - at least in guinea pigs; the 10db improvement in hearing threshold is what is considered necessary in order for an intervention to be clinically meaningful).

      upload_2015-1-21_22-20-18.png

      The above chart indicates that the drug would be able to restore hearing almost on par with what the natural hearing restoration process achieves in fish and birds. However, I don't want to go much further on this subject; I'd be more comfortable digging out some proper answers from GenVec.
       
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    8. rsmcfar

      rsmcfar Member

      Tinnitus Since:
      02/28/2014
      These are all the slides from the Genvec presentation on cgf-166.
       

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    9. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      Always interesting info, keep it up! I think the Genvec approach is a significant one in tinnitus as well as hearing restoration.
      I strongly believe that since a drop in hearing cause Tinnitus, the reverse process could logically eliminate it. We just can't know for sure since it hasn't been done yet. But it does occur for the non permanent tinnitus, the one day tinnitus you get when coming out of a loud place. This goes away as the hearing comes back to normal. A similar process could happen if and when a cure is found.

      Imagine that... what an achievement that would be, a true miracle! Would make all the other experimental would-be medicines (AM-101, etc) obsolete.

      I wonder, are they (Genvec) also interested in tinnitus specific subjects/cure?
       
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    10. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
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      Hi,
      I recently read in his twitter, that Mr. Gerk is very optimistc

      Hi,
      this is a statement from 2 other researchers of inner ear hair cell regeneration made last year when I asked
      them about their opinion about the Novartis/Genvec Trial.
      The main reason behind this statement was the fact, that no other lab could reproduce the results
      they achieved in 2005. So the biggest problem is still to get hair cell regenerated in the adult cochlea.
      In general, a lot of positive studies have been made in young cochleas... many approaches lose regeneration capacity rapidly as the ear ages...

      But my hope is, that Novartis/Genvec have other data. It still wouldn't make sense to make human trials in adults if they aren't certain of a positive effect.

      Maybe we get some more information soon.

      On Mr. Gerk's Twitter, he stated, that they are excited about the potential so far.
      What ever this means

      Greets Tom
       
    11. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      What are they excited for since the treatment did not acomplish anything by now?
      Perhaps they will try again with another dosage?
       
    12. earsnothappy

      earsnothappy Member

      Tinnitus Since:
      May 2014
      I'd like to see them make an attempt with someone who has had acoustic trauma versus someone who had meningitis.
       
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    13. rsmcfar

      rsmcfar Member

      Tinnitus Since:
      02/28/2014
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    14. Ken219
      Frustrated

      Ken219 Member

      Location:
      New York Area
      Tinnitus Since:
      Summer of 1990
      Cause of Tinnitus:
      Noise exposure?
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    15. tomytl
      Grumpy

      tomytl Member Benefactor

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    16. rsmcfar

      rsmcfar Member

      Tinnitus Since:
      02/28/2014
      GAITHERSBURG, Md., Feb. 2, 2015 /PRNewswire/ -- GenVec, Inc. (GNVC) today announced that its President and CEO, Douglas J. Swirsky, will present a corporate overview at the 17th Annual BIO CEO & Investor Conference at 1 p.m. EST on Monday, February 9, 2015 at the Waldorf Astoria Hotel in New York City.

      The live and archived webcast of Mr. Swirsky's presentation will be available at the following link: http://www.veracast.com/webcasts/bio/ceoinvestor2015/68117384.cfm. This link will also be available on GenVec's website. To access, visit www.genvec.com, click on "Investors and Media," and select the "Presentations" option under the "News/Events" menu. The webcast replay will be accessible for 90 days.
       
    17. rsmcfar

      rsmcfar Member

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      02/28/2014
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    18. rsmcfar

      rsmcfar Member

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      02/28/2014
      I guess I should have read the blog before posting!

      It sounds like they have dosed at least three people. The clinical trial is set up to test three people in succession to see if the procedure and virus are safe and then to move on to cohort testing at different dosing levels. It sounds like they have completed the first three safety cases. If you read the tea leaves in the last paragraph it sounds like this may have worked on the second dosed patient.
       
    19. spingee
      Wtf

      spingee Member

    20. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      Interesting. Digging into those links, I found this: http://www.novartis.com/stories/discovery/2014-11-hearing-loss.shtml
      Somewhere in it, it is mentioned that:
      "severe hearing loss might improve to moderate hearing loss" and "moderate loss might move to mild loss or normal hearing."
      What is the meaning of this? If tinnitus is caused by hearing loss (like acoustic trauma), moderate and not extreme, possibility of restoring normal hearing is what this therapy will offer, if successful.
      So if 50 percent restoration is achievable, deaf people will be able to hear again, and people with moderate hearing loss will come back to normal more or less.
      My guess is if that happens, tinnitus will go away just as it came. Most of it anyway.

      Most encouraging!
      Lets just hope:
      1) They succeed in hearing restoration
      2) No sideffects are presented from the treatment.
       
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    21. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
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      just found a new paper about atoh1... it looks, like the treatment with atoh1 can be further developed.
      Maybe something like this happened in the labs of Novartis, compared to the public results in 2005.
      http://www.ncbi.nlm.nih.gov/pubmed/25648190
       
    22. spingee
      Wtf

      spingee Member

    23. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      If I understood correctly, they talk about using more genes than atoh1, to ensure the success in hearing restoration.
      They claim that using just atoh1 is not sufficient. Atoh1 has been shown to convert residual supporting cells into hair cells with restoration of function in some cases. They want to ensure correct function of these new hair cells, by using other genes.

      So let them start their own research! As they have already done so, in mice. The hearing restoration using gene therapy is a very promising way to cure hearing loss.
       
    24. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
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    25. James White
      Anime

      James White Member Benefactor

      Location:
      Toulouse, France
      Tinnitus Since:
      April 2013
      Cause of Tinnitus:
      Maybe loud music. Not sure.
      They will be enrolling 45 patients, that's quite a lot for gene therapy! Interesting
       
    26. RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      Is there any update on his progess? I check his twitter account but I dont see anything. Its been 5 months now since his procedure and I'm really hoping it has benefited him. You would think that this would get more attention.
       
    27. NiNyu

      NiNyu Member

      Tinnitus Since:
      29/12/2014
      Cause of Tinnitus:
      barotrauma? stress?
      Someone said probably in 2025.. (sigh)
       
    28. RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      NiNyu, I have a feeling its going to be before 2025. Rob Gerk was administered the drug by Novartis. They have the next trials ending in 2017, same drug. Then probably another set of trials. I believe in one of the many articles I read they said 5 years for a solution. Not a cure, but something that takes a person from profound to moderate loss. I'll take that. They administered Gerk and went back to Switzerland and they invested 500 million bucks in a new division for hearing loss drugs and experimentation. They can smell the money, they have made the investment, and they want to be the first. We are all going to get fixed up and go party it up somewhere. I'll buy the first round.
       
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    29. attheedgeofscience
      No Mood

      attheedgeofscience Member Mighty Benefactor Hall of Fame

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      I have not been in contact with Rob Gerk since my last update. However, @Zimichael has twice been in contact with one of the folks from GenVec Inc and this person agreed with us how a patient with meningitis would not be considered the ideal candidate for a treatment such as CGF166. Meningitis causes not only cochlear but auditory nerve damage as well (potentially at least). However, certain decisions were made for "political reasons" by Novartis apparently.

      On a side note, I managed to track down a rather unique case study on a patient with HL caused by meningitis (i.e. same cause as with Rob Gerk) and who was treated with stem cells of the same type I had. What is interesting about this case study is that it was done already in 2009(!) and with existing technology and... it was done on a 4 year-old patient who - because of his age - could not be administered a normal hearing test. So an objective ASSR hearing test was used instead (meaning the results could not have been manipulated by the patient, for instance).

      As can be seen in the attachment, some gain in hearing was actually achieved. And while the results may seem very modest to some, one should remember that a 10-db improvement on an audiogram means your hearing is twice as good.

      The reason non-embroynic stem cells can achieve some gain in hearing is because not all hair cells are lost during an auditory insult (or pathology). As long as there are some remaining hair cells, a certain degree of restoration can be achieved with adult MSC.

      attheedgeofscience
      16/MAR/2015.
       

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    30. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
      10 Years
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      unknown
      Thank for your update and info.
      But what do you mean by:
      However, certain decisions were made for "political reasons" by Novartis apparently.
      ???

      Greets Tom
       

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