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Tinnitus > Anyone know of any progress with Genvec/Novartis (atoh1)

Buzzin
#1 Posted : Saturday, September 10, 2011 1:54:41 AM
Rank: Newbie


Joined: 8/15/2011
Posts: 25
Hi all,

I was just wanted to ask if anyone knows of any progress with Genvec/Novartis (atoh1)? There had been previous post by people on this forum. (Mr. Micro & Wongtonlim3)

(11/2010) that Genvec/Novartis are looking to move their hearing regeneration program to the clinic in the next 12 to 18 months with a phase I clinical trial.

(2/2011) the CEO at Genvec stated on a conference call webcast that they are working at moving their therapy into clinical trials soon.

I wish they would hurry up and start the clinical trial before we all pass away from old age!
Mr Micro
#2 Posted : Saturday, September 10, 2011 1:05:16 PM
Rank: Newbie


Joined: 6/8/2011
Posts: 23
Hi ,

It sounds like next year Genvec will proceed with phase one clinical trials for the atoh gene therapy / hair cell regeneration program.

You can listen to as well as see the latest report / conference details from Genvec here ,
http://ir.genvec.com/pho...=1601774&highlight=
or ,
http://www.veracast.com/...thcare2011/45302499.cfm

Hopefully it does move to the clinic soon , it will still need a good amount of time in testing before it was even considered for the market
but its a good start for sure.

Best Regards.
Buzzin
#3 Posted : Saturday, September 10, 2011 7:30:00 PM
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Joined: 8/15/2011
Posts: 25
Mr. Micro,

I have a question, but I dont know if you can answer it for me or not. If after Genvec/Novartis finish the first phase clinical trial their product (atoh1) proves safe and it restores the hearing. Do they still have to continue with the other phases before the FDA or EMEA will let it proceed to be on the market?
Mr Micro
#4 Posted : Saturday, September 10, 2011 10:52:32 PM
Rank: Newbie


Joined: 6/8/2011
Posts: 23
Hi ,

After phase one clinical testing it is standard to proceed with all other phases for compliance with the FDA.
Therapys can be used in special circumstances before all the clinical phases have been completed where the treatment could save life.
These situations are generally ruled as compassionate grounds of use where all other treatments have failed and the patient would die
before the treatment was available.
e.g. clinical cancer drugs used in terminally ill cancer patients.
Some therapys may pass certain phases or stages of phases quicker than initially planned , ie fast tracked , if they can be proven completely safe and effective early on ( low risk ) in testing or there is a high clinical demand , i.e. terminally ill cancer patients.
Because the technology being used by Genvec ( DNA manipulation / Adenovector Virus's) is still in general infancy there probably will
be extensive testing before it becomes available meaning a large saftey study will probably take place.
I would imagine they wont take shortcuts in testing this sort of medicine as there could be severe consequences to do so.

Best Regards.
Buzzin
#5 Posted : Saturday, September 10, 2011 11:32:45 PM
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Joined: 8/15/2011
Posts: 25
Mr. Micro,
Thank you for answering my question. You are absolutely right about everything you posted. I guess I am just so very anxious for a cure I let myself hope that we would not have to wait 8 to 10 years for this to go though the trials before it was approved. It sure seems a very long time away, especially when you have severe tinnitus.
wongtanlim3 at yahoo.com
#6 Posted : Sunday, September 18, 2011 2:16:28 PM
Rank: Newbie


Joined: 6/8/2011
Posts: 8
hi

Wongtanlim here...

Just today , when I am watching a movie The Hanged Man, the T felt bearable but I take solace millions are with me and we are all hanging on...
Buzzin
#7 Posted : Saturday, September 24, 2011 1:23:47 AM
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Joined: 8/15/2011
Posts: 25
Mr. Micro, Wongtanlim3, or anyone else

Does anyoneone know of other companies that are do research in regeneration of hair cells like Genvec/Novartis and if they also might be starting human clinical trials anytime soon. Is anyone out there like myself that hopes that gene therapy will end our problems with hearing loss, and this dreaded tinnnitus?
vandal
#8 Posted : Monday, September 26, 2011 10:35:55 AM
Rank: Junior Member


Joined: 6/8/2011
Posts: 30
Buzzin wrote:
Mr. Micro, Wongtanlim3, or anyone else

Does anyoneone know of other companies that are do research in regeneration of hair cells like Genvec/Novartis and if they also might be starting human clinical trials anytime soon. Is anyone out there like myself that hopes that gene therapy will end our problems with hearing loss, and this dreaded tinnnitus?


Hi Buzzin,

Here is one more from Audion/Sanofi
http://audiontherapeutic...research-collaboration/

They have yet to produce anything but they do have patents investment, but I'm not sure they will come up with something.
Below is the link to Albert Edge.
http://www.masseyeandear...epl-investigators/edge/

The other one I know of is Sound Pharma, so far nothing from them yet.
Buzzin
#9 Posted : Tuesday, September 27, 2011 1:19:52 AM
Rank: Newbie


Joined: 8/15/2011
Posts: 25
Hi Vandel,

Thanks for responding. Could you let me know of the sites for Sound Pharma. Everything I have seen so far on internet was old. Thanks again.
vandal
#10 Posted : Tuesday, September 27, 2011 3:19:47 AM
Rank: Junior Member


Joined: 6/8/2011
Posts: 30
Buzzin wrote:
Hi Vandel,

Thanks for responding. Could you let me know of the sites for Sound Pharma. Everything I have seen so far on internet was old. Thanks again.

Sure, here the link,
http://www.soundpharmaceuticals.com/
look for the news.
http://www.soundpharmaceuticals.com/news.html

And here what WongTanLim just put up from GlaxoSmithKline
http://www.inpharm.com/n...k-autifony-therapeutics
As usual, no new yet but they say a human trial by early 2013.

I just don't know to be happy or sad about it. I just hope there will be no hiccups along the way.

Here where you can dig up old news for wongtanlim blog.
http://wongtanlim3.blogspot.com/
Kapy1000rr
#11 Posted : Tuesday, September 27, 2011 4:40:34 AM
Rank: Newbie


Joined: 6/26/2011
Posts: 17
Hi Vandal,

Isn't Albert Edge part of the team with Audion and Sanofi?

I thought I read where his research was being collaborated with Audion out of Amsterdam and of course Sanofi boosting their efforts hopefully.

Hope all of you are doing well.

I am very hopefull and happy that at least some big pharma folks are looking at this disorder seriously now. It is a extreme long time coming for all of us.

KP
vandal
#12 Posted : Tuesday, September 27, 2011 5:13:57 AM
Rank: Junior Member


Joined: 6/8/2011
Posts: 30
KP,
Yes he is. He is the one whom setup Audion. That's why I put the link to him.

Yes, certainly some good news. Although it seems to me they are in a race to come up with a therapy, but they are nowhere near a human clinical trial race. I just hope there will be more of them in this therapy for hearing loss and tinnitus.

Thanks, KP. I still coping well with my daily sudden imbalance attacks and spikes of loud tinnitus. Going to a chiropractor may not help me to rid of T but I had a pain at my right arm shoulder joints for many years. So far, my attacks intensity level was reduced but not gone. I would rate it at a reduction of 15% from my previous condition. It means that I have better days without attacks for 2 or 3 days.
Kapy1000rr
#13 Posted : Wednesday, September 28, 2011 3:44:31 AM
Rank: Newbie


Joined: 6/26/2011
Posts: 17
Thanks Vandal,

Sorry to hear about your battles.

Were you diagnosed with Meneires? Or are you having other problems non-associated.

My doctor diagnosed me with a form of Menieres, but because I have not had episodes of vertigo, dizziness or imbalance they are more convinced it's just hearing loss.

I had a severe case of the flu about 3 years ago that made me run a major fever. During this time I had went to a very loud concert as well, which I am sure didn't help.

However I was left with a feeling of water in my ears, fullness, pain, ringing, popping, distortion you name it. I think it was more due to the concert than anything else.

These symptoms lasted for at least two years. Now I get mild fullness, ringing all the time of course and resulting hearing loss that makes it difficult for me to understand communication in noisy situations like restaurants, pubs, meetings and gathering of large groups talking at the same time etc.

I have tried a hearing aid, but it certainly does not help in the above situations so I figured what's the use.

Like many of us on this site I am glued to the internet reading, researching and hoping that some of the latest Stem Cell/Gene therapy discussions will lead us all to salvation.

Thanks again for your reply, hope you get to feeling better.

KP
vandal
#14 Posted : Wednesday, September 28, 2011 7:30:15 AM
Rank: Junior Member


Joined: 6/8/2011
Posts: 30
No, it was unlikely to be meneires although the symptoms are the same but anything goes.

Take care KP, I hope that some guide about vitamins like B,C and E can help you to reduce the on going hearing loss and pain. I read that these Vitamins are anti-oxident which can help reduce the chances of nerve damaged. Good luck.
vandal
#15 Posted : Wednesday, October 05, 2011 8:30:54 AM
Rank: Junior Member


Joined: 6/8/2011
Posts: 30
Buzzin,

Here's one more from Vitro Diagnostics Inc.Vitro, just found it today.

They aren't doing anything for human trials, but seems like they are in the business of supplying stem cells. Strange!?
Kapy1000rr
#16 Posted : Thursday, October 06, 2011 6:50:12 AM
Rank: Newbie


Joined: 6/26/2011
Posts: 17
Hey Buzzin,

Great link to Vitro Stem Cells.

Sounds very promising doesn't it?

Although they just supply the stem cells, it also sounds as if the right cocktail of cells and drugs have been found.

Like I have said in some past posts, all of this is just waiting for somebody with big pockets to pick up the patent and start producing results so that they can then profit off of all of us needing the treatment.

I just wonder why it is taking somebody so long to decide to do this. As the reasearch shows millions of us are out here just waiting to open our wallets to get treatment.

Oh well, again let's hope the research results into practice soon.

Take care,

KP
Kapy1000rr
#17 Posted : Friday, October 07, 2011 5:23:47 AM
Rank: Newbie


Joined: 6/26/2011
Posts: 17
Hey Buzzin check this out as well.

I just read this today.

http://www.hearinglosswe...dical/cures/hair/hhf.htm
Buzzin
#18 Posted : Saturday, October 08, 2011 4:19:07 AM
Rank: Newbie


Joined: 8/15/2011
Posts: 25
Hi Kapy and Vandal,

Thanks for posting those link sites. I agree that it does sound promising. I hope that Vitro finds partnership companies with deep pockets that wants to do clinical trials and commerialize thier stem cell products soon! I am also glad to see more researchers join forces on hair cell regeneration. I just hope it would not take ten years or so to start clinical trials like they reported. I appreciate you guys posting on the research you find on the internet. Please continue as will I. This is the only thing giving me any hope, for my biggest fear it that we will have to live with this demon (tinnitus) the rest of our lives!
EddTekk1
#19 Posted : Sunday, October 09, 2011 1:05:51 PM
Rank: Newbie


Joined: 6/8/2011
Posts: 3
Hi All,

the Deafness Research Foundation changed its name to Hearing Health Foundation.

There will be a webcast available from 11th of October on their webpage: http://www.drf.org/

I hope they will really find some way to improve stem cell research and usage in future.

For an general overview of research activites in tinnitus / hearing / dizziness please visit: http://www.tinnitus.de/s...hwindel-Hörverlust

Hope that one day this **** disease can be cured or treated to get some partial relief at least.

Regards,
Edtek

londoner50
#20 Posted : Friday, January 04, 2013 9:52:17 PM
Rank: Junior Member


Joined: 1/4/2013
Posts: 26
unfortuantely there might be more work to de done on atoh1 before human trials on adults, although trials invol:
ving younger people might be possible soon
http://news.emory.edu/st...hearing_loss/index.html

i suppose this means that there are two subgroups, a young ie less than a certain age and the rest.


these are quite new findings 2012 so they might not have been know by genvec at the time but are now. i guess the trial involving young people less than could go ahead.

any update on this would be welcome.

i believe university of iowa is doing further work on atoh1 and other genes and no doubt other labs are investigating whats needed for adult regeneration in addition to atoh 1,

goes without saying the sooner we get to human trials the better.








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