Novartis Pauses Study of GenVec's Gene Therapy CFG166 (UPDATE May 2016: Trial Is Again Continuing)

maybe as long the trial is looking for patricipants, maybe there is hope
that they will continue after some checks, but I don't know what latency
this site has...
https://clinicaltrials.gov/ct2/show/NCT02132130

but for GenVec it's hard, the trial is absolutely not in their hands, it's just about to get
their milestone payment or not.

 

This is a quote from: http://finance.yahoo.com/news/inplay-briefing-com-055139997.html#gnvc

quote:
Novartis will continue to collect safety and efficacy data on the nine patients currently enrolled in the study before determining whether to proceed with incremental patients.
End quote.

I do hope that it is not the efficacy that is questioned. This was an update from today.

 

GenVec and Novartis are set to start back up and move forward after this news -

http://ir.genvec.com/press-releases...vides-update-on-hearing-loss-clinical-program

Ha-Le-Lu-Yaaaa

 

Does it mean that this study will be completed in 2017?

 

I'm pretty sure it will. I remember reading that the pause would not affect the end date for the study. I can't remember exactly, but I remember it being in 2017.

 

It seems the pause may be over:

FDA Lifts Clinical Hold On CGF166

http://www.prnewswire.com/news-releases/fda-lifts-clinical-hold-on-cgf166-300302844.html

 

http://www.streetinsider.com/dr/news.php?id=11857491

Must be some sort of good news if some patients are seeing improvement...

 

Where do you read that some patients are seeing improvements?

 

Has the trial been halted twice?

Quote:
"We look forward to the near-term enrollment of new patients and believe that the trial will be completed sometime in 2017 as previously expected." End quote.

So they will be accepting new patients?

 

No, only once.

Yes, based on what they said when they suspended the trial, they were part way through the dose escalation round.

 

I have been in touch with one of the parrticipants. I can't say more due to confidentially.

On second note, if they paused the study and then restarted it, the trial must he showing some sort of promise otherwise they wouldn't be carrying on. Most trials go bust in phrase 2

 

In the other thread Nick posted that one of the participants Jeff didn't see any results, in fact it actually made his hearing worst. This is good news though. Maybe the dosage does matter and this was a contributing factor. I hope they can figure out why some people did see improvement and not others though.

 

How many phase/year need to be done and where are we staying at?

 

There is 4 phases to drug approval And many years.

 

Actually since they are testing it on subjects that have hearing loss that means that they must already have done pre-clinical trials and phase I (for safety). That means this ought to be a phase II trial and the last one which is phase III can be done "on the market". So theoretically a release can be made after this trial. However I'm guessing it won't. I guess it will take at least one more trial, if successful.

 

There are 3 phases for approval. The fourth phase is post-approval surveillance to look for issues that didn't show up during the pre-approval trials.

Normally phase 1 is done on healthy volunteers, but it wouldn't make any sense to do inner ear surgery on healthy volunteers so the current trial is a Phase I/II study. The first cohort of 3 people at a low dose is effectively Phase I to check for safety at a low dose. The following cohorts in the dose escalation part of the trial can be thought of as Phase II. If it is successful, there will be a larger phase III trial - presumably with more than 3 sites to get a larger sample more quickly. As far as I know in the US phase III trials are pre-market.

 

Inject me now! I said now!

 

So if this trial goes well we could see it on the market within 2-3 years best case scenario?

 

I this is pretty helpful. It talks about the different drug trial stages and what each are for.
https://en.wikipedia.org/wiki/Phases_of_clinical_research

 

Anu update from Genvec..

 

This one is optimistic:

Gels to Repair Hearing Loss? Drugmakers Try New Ear Treatments

Sarah Povey spent her youth at rock concerts, sometimes going out five or six nights in a row, soaking up the live sound from nearby speakers. By her late 20s, she was diagnosed with severe tinnitus, a ringing in the ear that makes it hard to listen to any music at all.

“I was very, very emotional,” said Povey, now 44. “I felt hopeless because there was no cure, there was nothing in the foreseeable future that gave me hope that it would go away.”

That may change within the next decade as understanding of the intricate inner ear improves. Drugmakers are jumping in to offer innovative treatments like gels and gene therapy to prevent or even reverse tinnitus and hearing loss -- which affect 25 million and 48 million people in the U.S., respectively. Undeterred by recent setbacks in clinical trials, some pharmaceutical companies see hearing-loss drugs turning into a multi-billion dollar market, bolstered by the stigma associated with wearing hearing aids and exposure to loud music through headphones in younger generations.

Tiny Hair Cells
When a sound wave arrives at the ear, it hits the eardrum, whose vibrations are carried by three little bones to the inner ear. There, the vibrations travel through the fluid contained in the cochlea, a snail shell-shaped organ, and are picked up by tiny hair cells that convert kinetic energy into electric signals transmitted to the brain. Hearing loss and tinnitus happen when the hair cells or the nerves they connect to are damaged or killed.

One key advance in technology is the ability to deliver drugs more precisely into the inner ear, an isolated part of the body that’s difficult to reach with conventional drugs absorbed through the bloodstream. Auris Medical Holding AG and San Diego-based Otonomy Inc. are working on sudden cases of hearing loss, usually brought on by loud noises, infections or after certain types of chemotherapy. Their drugs, administered within days of the trauma, are molecules suspended in gels that are injected through the eardrum into the middle ear and slowly disperse into the inner ear.

The U.S. Department of Defense is particularly interested. Auris has tested its drug on chinchillas deafened by the simulated noise of an M16 rifle at a Navy medical center in San Diego. It’s now running two late-stage human trials, and expects to start seeing results next year.

Auris, based in Switzerland, estimates the market for acute hearing loss at $600 million annually, and at $750 million for acute tinnitus. Other drugmakers, including GenVec Inc. and startup Decibel Therapeutics, see the larger market of hearing loss reaching billions of dollars in sales.

Gene Therapy
Swiss pharma giant Novartis AG is working with GenVec to use gene therapy to stimulate the growth of hair cells. A modified virus delivers a copy of a gene called Atonal 1 that tells supporting cells in the ear to convert into hair cells.

While gene therapy probably won’t help people who are born deaf, because the brain hasn’t developed to interpret sound, GenVec Chief Executive Officer Doug Swirsky says he’s hopeful it will work for patients who lost their hearing at a young age. GenVec’s product could reach the market in three to five years.

Startup Frequency Therapeutics is going a different route. The company, co-founded by Massachusetts Institute of Technology scientist Bob Langer, is trying to activate stem cells in the cochlea to regenerate hair cells.

In the womb, “the biology was active in creating those hair cells, and once you’re born the biology shuts off,” Frequency Therapeutics CEO David Lucchino said. “What if you could re-cue these regenerative cells that are just hanging out and put them to work again as the body intended?”

Trials Fail
It’s been hard to get results for hearing drugs in humans, so far. Auris said in August that its experimental treatment for acute tinnitus didn’t meet primary goals in a trial. The company has amended the design of a second tinnitus trial and is waiting for results. Autifony Therapeutics Ltd., a London-based firm that was spun off from GlaxoSmithKline Plc in 2011, failed in two mid-stage trials this year aimed at patients with tinnitus and age-related hearing loss. Its drug, a pill, is designed to improve signaling within the brain.

Part of the challenge comes from measuring tinnitus, which is detected through self-reporting and can be hampered by the subjectivity of patients’ experience. Povey, the patient who was diagnosed in her late 20s, says she’s learned to live with her tinnitus with the help of counseling along with a noise generator that plays a tone in her ear.

Doug Brough, chief scientific officer at GenVec, says he hopes patients will realize that the first drugs won’t be “a magic bullet,” but he hopes they’ll bring meaningful change. He knows about the impact of hearing loss first-hand. Due to childhood infections, his late mother lost her ability to hear some frequencies of sound, including ranges in Brough’s voice.

“Wouldn’t it be great if this drug could have my mom hear me?” he said.

http://www.bloomberg.com/news/artic...els-gene-therapy-to-help-reverse-hearing-loss

 

This Trial is failed right?

 

We don't know.

 

Lol but they postponed completion date from 2017 to 2019

 

Let's hope this will work !

 

I'm assuming it is due to trouble recruiting participants. See https://www.tinnitustalk.com/thread...ybe-we-can-know-more.3131/page-74#post-238438

 

Can you send a link about postponement ? I remember that they said they will finish phase 2 in summer 2017.

 

its in official trial paper, you can even check history changes

https://clinicaltrials.gov/ct2/show/NCT02132130