InVivo Therapeutics gets conditional approval for changes to safety trial protocol

The FDA grants "conditional approval" for changes to the protocol and supporting documents for a safety trial of InVivo Therapeutics' (NVIV +10%) degradable polymer scaffold.

The company says it will send the protocol and materials to its six sites next week "so that those sites can start their Institutional Review Board reviews and finalize contracts."

NVIV expects "that the first site will be ready to accrue subjects in the first half of March." (PR)

Comments (12)
  • Esekla
    , contributor
    Comments (4662) | Send Message
    I'd been commenting in favor of caution while analysts here talked the stock up under Reynolds. When he left, I hailed it as a positive for the company, despite downgrades from those same analysts who should have been warning about his overly promotional style all along.
    26 Dec 2013, 03:04 PM Reply Like
  • bufnyfan1
    , contributor
    Comments (223) | Send Message
    So What--Reynolds has been gone since August 2013-its quite clear the interim CEO (Mr. Astrue) has refocused In Vivo's efforts toward getting the scaffold trial started (and now the FDA has even allowed the changes in the trial In Vivo was asking for which should expediate the study even faster)--This is a revolutionary approach to acute spinal cord injury that is going to bring hope to many individuals where there was no hope before---another friend of mine put it best "you can never own enough stock in NVIV".
    26 Dec 2013, 03:56 PM Reply Like
  • paolocipolla
    , contributor
    Comments (27) | Send Message
    How much will it cost just to get the clinical trail done?
    In the best case scenario how much will patients get better?
    Will the recovery (if any recovery will happen) really make a difference in patients quality of life?
    How many people can really (potentially) benefit from this therapy?
    All the answers to these questions are important to know and don't have much to do with what Mr. Raynolds use to say.
    I think InVivo will go bankrupt even before completing the trial. Their approach to spinal cord injury is economically baseless and scientifically very foggy at best in my personal opinion.
    26 Dec 2013, 04:35 PM Reply Like
  • gatlingg
    , contributor
    Comments (380) | Send Message
    since Langer is the real guy behind this foggy idea perhaps you should take it up with him. Since he seems to be recognized as a genius by his peers and teaches at arguably the best scientific college in the world obviously is a mistake that you can see through. some of us believe preventing folks from being paralyzed just might qualify as making a difference in a patients quality of life. Of course this being a safety trial, efficacy is not the primary endpoint but one that many of us believe might also be attained. But I am curious that after having done your due diligence, why you believe Invivo will go bankrupt before completing the pase 1 trial? I am also curious why folks who don't seem that informed find it so easy to just bash a company; is it the holiday season got you down?
    26 Dec 2013, 05:57 PM Reply Like
  • paolocipolla
    , contributor
    Comments (27) | Send Message


    I would love to discuss this with Langer if I have a chance. This therapy at best will have a neuroprotective effect which in most acute ASIA A patients will produce no returns. To prevent falks from being paralized you have to prevent accidents. Once paralysis happens you have to reverse it i.e. you have to repair the injured spinal cord which this scaffold can't do.


    Then I said: "I think InVivo will go bankrupt even before completing the trial" which means the whole trial, not just phase one.


    If InVivo wants to market this product they need to prove efficacy. How many patients do they need to recrute to complete the whole trial?
    How many years will it take?
    What's InVivo burn rate?
    Geron took two years to recrute 5 patients with 7 centers open to enroll patients... not very efficent economically, right?
    Hope I am worng, but I am afraid InVivo people don't what they are doing.
    BTW, long before Geron started the trial me and others pericted the end we have seen.
    26 Dec 2013, 08:02 PM Reply Like
  • dylanwaits
    , contributor
    Comments (5) | Send Message
    Insiders sell this stock like it has the plague.
    27 Dec 2013, 01:19 AM Reply Like
  • nateboling
    , contributor
    Comments (45) | Send Message
    Part of an automatic selling plan that has been discussed to death since it was implemented. The prior CEO wanted to diversify since most of his net worth was tied up in this one company. It would be imprudent for him to do otherwise. I am not saying I agreed with his shameless promoting though.
    27 Dec 2013, 02:52 PM Reply Like
  • nateboling
    , contributor
    Comments (45) | Send Message
    Paolo, Invivo is trying to prevent the inflammation process that causes the secondary scarring at the injury site. Nerve signals can move through any healthy tissue that is spared. They have had interesting results in primates that seem to indicate this works. Will it work? Well that is why we have trials. They are not trying to reverse paralysis for chronic spinal cord injuries. Not yet anyways. No harm in being skeptical though. I am hoping for the best.
    27 Dec 2013, 02:45 PM Reply Like
  • paolocipolla
    , contributor
    Comments (27) | Send Message
    nateboling, I know what invivo is trying to prevent.. actually to be more precise the strategy is to prevent the secondary damage that follows an injury, that could result in some recovery of function and in less scarring.. I can't say if it will work or not, but from what I know I don't expect to see a significant recovery.
    I hope they will find a way to really get the trial done, but economically I don't see how they can make it.
    Problem with researchers is that they do research without thinking to how to translate it into cures. So they often discover interesting things that ends up in the valley of death. We should have wiser researchers or at least wiser founding institutions that direct founding in a more productive way i.e. to dicover things that people can really benefit from in the real world.
    28 Dec 2013, 06:32 AM Reply Like
  • nateboling
    , contributor
    Comments (45) | Send Message
    Paolo, thanks for your thoughts. I see you are suffering from a SCI so you have every right to be skeptical. It is probably best to keep expectations low for now. Still, I am cautiously optimistic. Keep in mind, Invivo is the only group so far to successfully make the jump from rodents to primates in pre-clinical testing. As for going bankrupt? I do not see that happening, worst case scenario is more dilution. Best of luck to you and if not invivo, I hope there is a group out there today working on a cure for chronic SCI.
    28 Dec 2013, 11:11 AM Reply Like
  • pistol1p
    , contributor
    Comments (8) | Send Message
    Very well said nate, and I 2nd your thoughts regarding Paola and Invivo.
    30 Dec 2013, 06:35 PM Reply Like
  • Cassandra.says
    , contributor
    Comments (91) | Send Message
    Despite Jason Napodano's painstaking efforts to spell out the trial requirements for a device with a humanitarian device exemption, we keep getting these ignoramuses viewing the NVIV scaffold and its approval process as though it was a drug.


    Approval for the scaffold does not require proof of efficacy. Improvement after spinal cord injury requires replacing of severed communications. Scar tissue is barrier to establishing new neural connections. Device prevents scarring. How hard is this to understand? I am suspicious of the bona fides of posters who do not get it. I think they have an agenda.


    Anyone wanting the facts should check out Jason's blogs.


    Can anyone sincerely question that it would improve one's quality of life to be able to breathe unassisted, and therefore talk, even if one still could not walk?


    2 May 2014, 03:05 AM Reply Like
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