Page 1 of 4 1234 LastLast
Results 1 to 10 of 31

Thread: Novel Therapy for Chronic Spinal Cord Injury Gets Fast Track Status

  1. #1
    Senior Member mj23's Avatar
    Join Date
    Sep 2005
    Location
    Chicago, IL
    Posts
    497

    Novel Therapy for Chronic Spinal Cord Injury Gets Fast Track Status

    Novel Therapy for Chronic Spinal Cord Injury Gets Fast Track Status


    Diana Ernst, RPh







    Fast Track designation allows for more frequent meetings with the FDA, as well as eligibility for accelerated approval and priority review.


    The Food and Drug Administration (FDA) has granted Fast Track designation to AXER-204 (ReNetX Bio) for the potential treatment of chronic spinal cord injury.

    AXER-204 is a human fusion protein that acts as a decoy for the myelin-associated inhibitors of axonal growth known as Nogo-A, MAG, and OMgp. The decoy receptor, known as Nogo Trap, is believed to bind to these inhibitors, thereby allowing the body to grow nerve fibers.

    A phase 1/2 trial (RESET) is currently being conducted in 66 patients with traumatic spinal cord injury (≥1 year) to assess the safety, tolerability, pharmacokinetics, and efficacy of the treatment. During the double-blind phase, patients will be randomized to receive either AXER-204 administered by lumbar puncture and slow bolus infusion or placebo. Results of the study are expected sometime in 2021.

    ?This Fast Track designation from the FDA recognizes the high unmet medical need in patients with SCI,? said Erika R. Smith, MBA, CEO of ReNetX Bio. ?Fast track designation will help facilitate ReNetX Bio?s development of AXER-204, and potentially expedite future regulatory review of AXER-204 for patients with SCI.?




    According to recent guidelines, current treatment options for chronic spinal cord injury include neurotization or nerve bridging, neurostimulation/neuromodulation and neuroprosthesis, cell therapy, and neurorehabilitation. While some pharmaceutical therapies have shown benefit (ie, acidic fibroblast growth factor, granulocyte colony-stimulating factor), more studies are needed to confirm these results.

    For more information visit renetx.com.

    https://www.empr.com/home/news/drugs...7b1PZuYzX_qDhw


    C-5, 6 SCI. Took about 6 months to walk. Walking full time. Without any assistance since Nov. 2003 and will make a full recovery

  2. #2
    Senior Member lunasicc42's Avatar
    Join Date
    Oct 2004
    Location
    Lutz, Fl USA*********C456
    Posts
    2,429
    lol smh
    Attached Images Attached Images  
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  3. #3
    Senior Member
    Join Date
    Apr 2016
    Location
    Cincinnati, Ohio, USA
    Posts
    2,650
    Are there any encouraging results from the current phase I study?
    T3 complete since Sept 2015.

  4. #4
    Senior Member lunasicc42's Avatar
    Join Date
    Oct 2004
    Location
    Lutz, Fl USA*********C456
    Posts
    2,429
    Quote Originally Posted by Mize View Post
    Are there any encouraging results from the current phase I study?

    I don't think it has been published yet
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  5. #5
    Quote Originally Posted by Mize View Post
    Are there any encouraging results from the current phase I study?

    Results of the study are expected sometime in 2021.

  6. #6
    Senior Member
    Join Date
    Apr 2016
    Location
    Cincinnati, Ohio, USA
    Posts
    2,650
    I meant leaks from participants, of course!
    T3 complete since Sept 2015.

  7. #7
    Senior Member Oddity's Avatar
    Join Date
    Oct 2008
    Location
    Virginia Beach, VA
    Posts
    3,937
    Blog Entries
    1
    Quote Originally Posted by Mize View Post
    I meant leaks from participants, of course!
    I heard it should be ready to cure us all in about 5 years.
    "I have great faith in fools; self-confidence my friends call it." - Edgar Allen Poe

    "If you only know your side of an issue, you know nothing." -John Stuart Mill, On Liberty

    "Even what those with the greatest reputation for knowing it all claim to understand and defend are but opinions..." -Heraclitus, Fragments

  8. #8
    The stock price has nearly doubled over the past few months. That doesn't mean anything for certain but it is interesting that the market is flashing positive sentiment.

  9. #9
    Quote Originally Posted by quadfather View Post
    The stock price has nearly doubled over the past few months. That doesn't mean anything for certain but it is interesting that the market is flashing positive sentiment.
    Renetx isn’t publicly traded.

    nervgen is

  10. #10
    First thought was - I would be injected with placebo ....
    www.MiracleofWalk.com

    Miracles are not contrary to nature, but only contrary
    to what we know about nature
    Saint Augustine

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •