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Novel Therapy for Chronic Spinal Cord Injury Gets Fast Track Status

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    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.?

    Related Articles



    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
    lol smh
    Attached Files
    "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

    Comment


      #3
      Are there any encouraging results from the current phase I study?
      T3 complete since Sept 2015.

      Comment


        #4
        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

        Comment


          #5
          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.
          http://spinalcordresearchandadvocacy.wordpress.com/

          Comment


            #6
            I meant leaks from participants, of course!
            T3 complete since Sept 2015.

            Comment


              #7
              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

              Comment


                #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.

                Comment


                  #9
                  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

                  Comment


                    #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

                    Comment


                      #11
                      Originally posted by Mize View Post
                      Are there any encouraging results from the current phase I study?
                      I was told:

                      There were 9 out of 24 people who have had it done (mid December).
                      Outcome assessments (from first 6 participants) have very positive standard deviations which sets up for higher potential of change detection in Multiple Dose study.
                      Follow-up Multiple Dose study is on target to begin in 2020 Q3/4
                      So not information that gets me excited at this point, and no details on the specific improvements, but they obviously believe it's on the right track.

                      Comment


                        #12
                        Hi all, fast track statuts is looking great !!
                        Anyway I will soon be 45 years post, things are going worse and it's beginning to be hard to survive. I don't wanna die without trying something, I wish I could buy some AXER-204 and go for the lumbar puncture or bolus infusion on my own, do you guys think it's possible ??

                        Comment


                          #13
                          Originally posted by George78 View Post
                          Hi all, fast track statuts is looking great !!
                          Anyway I will soon be 45 years post, things are going worse and it's beginning to be hard to survive. I don't wanna die without trying something, I wish I could buy some AXER-204 and go for the lumbar puncture or bolus infusion on my own, do you guys think it's possible ??
                          You can find out what is used in many compounds by investigating the patents on these things. Then find somewhere to compound them for you. Delivery will be hard to do right without a willing doctor/surgeon.

                          I'm aware of many people who are going this route, but for me the safety is a worry.

                          Comment


                            #14
                            Originally posted by niallel View Post
                            You can find out what is used in many compounds by investigating the patents on these things. Then find somewhere to compound them for you. Delivery will be hard to do right without a willing doctor/surgeon.

                            I'm aware of many people who are going this route, but for me the safety is a worry.
                            Hi and thanks for the reply, I've been googeling for the patent but I found nothing, do you have any idea how to go for compounding such fusion protein ?...
                            Concerning safety, we're on lumbar puncture or bolus infusion, I guess it's no big deal if it is compound by a serious lab..
                            What do you think ?..

                            Comment


                              #15
                              We do not allow discussions of illegally accessing experimental therapies.

                              Comment

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