CGF166 Clinical Trials Update

Some encouraging news on the hunt for a cure for sensorineural hearing loss: GenVec and Novartis have announced they intend to resume the Phase 1/2 (human) trials of CGF166.

For about 90% of people suffering from hearing loss, including me, the cause is sensorineural: the dying off of the hair cells in the cochlea that sense vibrations and convert them into neural electrical signals that flow to the brain.

(I have posted some background on the subject here.)

CFG166 is a biopharmaceutical agent developed by GenVec. Essentially it’s a very novel bit of genetic engineering designed to regenerate hair cells, and restore some level of lost hearing.

It’s now being tested in clinical trials by GenVec’s partner Novartis.  Nine people had received it.  But then in January, Novartis announced that they had paused enrolling more people for the trials pending a review.

The review by the study’s Data Safety Monitoring Board has been completed, and last month it recommended that the trial continue (subject to FDA approval).

“We believe that enrollment will start again in the coming months and that the trial will be completed sometime in 2017, as previously expected.”

– J. Swirsky, president and CEO of GenVec.

If CFG166 ever makes it to the marketing department they will likely end up giving it some pseudo latinate name like Otoagra or Earyola. I don’t care what they call it as long as it’s safe and effective. Fingers crossed.


23 thoughts on “CGF166 Clinical Trials Update”

  1. This is encouraging news. When do you think this will be available?
    And what sort of hearing loss will this adress mild, moderate, severe or profound?

    1. Indeed CGF166 offers hope. It’s aimed at those of us who suffer from sensorineural loss (aka age related). The promise is that it can regrow the hair cells in the cochlea that have been lost or damaged. There are three human trials now underway but this will be a long process before, and if, it is approved by the FDA. Fingers crossed. I will be posting an update in the next week or so. Keep an eye out for that, or better still please subscribe to my email notifications.

      1. Thanks, I’ll definitely keep an eye on your update in the next week or so. Of course, I was hoping for a rough number of years before this is available: 2, 5 ,10 … But I am guessing these are details you just don’t have at this point. I am already subscribed to your e-mail notifications.

        1. In fact, that’s the very question I am now researching and interviewing the scientists about. I update with the best estimate I can uncover.

          1. oh my God! You’re awesome! Other questions of interest may be:

            – Can this can alleviate sensorineural hearing loss induced tinnitus?

            But I will leave it there. You are awesome.

    1. I’m planning an update on CFG166 shortly. Please subscribe to our email alerts and you will know the minute it’s posted.

    1. I don’t know the answer to that for sure but I am afraid that it is very unlikely that they are accepting children for the trials. It’s still a new and potentially risky procedure.

  2. are trails available in Canada?
    I have 3 boys with age ranging from 21 – 16, and they all have varying degrees of sensorineural hearing loss.

    1. The CGF166 trials are only being conducted at those three US sites. But they are open to Canadians applying although Novartis will not cover transportation or accommodation.

  3. My daughter is 3 years old she has 80decibal of hearing loss is this treatment done on kids??and are there any side effects for this treatment

    1. Sorry daughter you daughter suffers from hearing issues. So far this treatment is only in trials and any side effects have not been reported as far as I know. But it’s important to remember that it will be sometime before it’s approved, or even if it will be approved.

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