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Just Published, the Cethrin results

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  • Just Published, the Cethrin results

    This is the long awaited report of the phase I/IIa trial of Cethrin.

    1. J Neurotrauma. 2011 Mar 8. [Epub ahead of print]
    A phase I/IIa clinical trial of a recombinant Rho protein antagonist in acute spinal cord injury.

    Fehlings M, Theodore N, Harrop J, Maurais G, Kuntz C, Shaffrey CI, Kwon BK, Chapman JR, Yee A, Tighe A, McKerracher L.
    University of Toronto, Surgery, 399 Bathurst Street, Suite 4W-449, Toronto, Ontario, Canada, M5T 2S8, 416-603-5627, 416-603-5298; michael.fehlings@uhn.on.ca.

    Abstract

    The Rho pathway has been shown to be important in the neuronal response to growth inhibitory proteins after CNS injury. BA-210 (trademarked as Cethrin®) blocks activation of Rho and has shown promise in preclinical animal studies of spinal cord injury. This is a report of a Phase I/IIa clinical study designed to test the safety, tolerability, and neurological status of patients following a single dose of BA-210 applied during surgery following acute spinal cord injury. Patients with thoracic or cervical SCI were sequentially recruited in this dose ranging, multi-centre study of 48 patients with complete ASIA A assessment. Vital signs, clinical laboratory tests, computed tomography scans , magnetic resonance imaging, and ASIA assessment were performed in the pre-study period and in follow-up periods out to one year after treatment. The treatment-emergent adverse events that were reported were typical for a population of acute spinal cord injury patients, and no serious adverse events were attributed to the drug. The pharmacokinetic analysis showed low levels of systemic exposure to the drug, and there was high inter-patient variability. Changes in ASIA motor scores from baseline were low across all dose groups in thoracic patients (1.8 ± 5.1) and larger in cervical patients (18.6 ± 19.3). The largest change in motor score was observed in the cervical patients treated with 3 mg of Cethrin where a 27.3 ± 13.3 point improvement in ASIA motor score at 12 months was observed. Approximately 6% of thoracic patients converted from ASIA A to ASIA C or D compared to 31% of cervical patients and 66% for the 3 mg cervical cohort. While the patient numbers are small, the observed motor recovery in this open-label trial suggests that BA-210 may increase neurological recovery after complete spinal cord injury. Further clinical trials in spinal cord injury with Cethrin are planned to establish evidence of efficacy.

    PMID: 21381984 [PubMed - as supplied by publisher]

  • #2
    Thanks Dr. Young. Did the authors posit any explanation for the seemingly more positive results for cervical injuries?

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    • #3
      Interesting.

      marked.

      Comment


      • #4
        Positive news. How soon till Phase III?
        Please donate a dollar a day at http://justadollarplease.org.
        Copy and paste this message to the bottom of your signature.

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        • #5
          Who owns the rights? Not Alseres right?
          And the truth shall set you free.

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          • #6
            Thank you, Wise.

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            • #7
              Approximately 6% of thoracic patients converted from ASIA A to ASIA C
              A couple questions... that seems low and also what percentage converted in the control group?

              Comment


              • #8
                Thanks Dr. Young. Can you interpret the results for us? Are these results positive or meh?

                I know these are more safety studies, but purely focusing on results.

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                • #9
                  YEAAAAAAAAAAAAAAAAAAAA! Cervical A's to C-Ds is absolutely freaking fantastic! And I finally picked a biotech stock that may not disappear. Any chance they'll try this acutely in atraumatic completes? I mean surgery is rarely done with a golden hour so there should be time to rule out non-permenant conditons like GBS where many recover.
                  Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

                  Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

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                  • #10
                    Cethrin is good but only if cethrin story and story of this
                    biotech stock was not connected with some murky, greedy games.
                    The Boston Globe text
                    I know that scientists from Toronto did pure and honest research here, regardless.
                    Hope that Cethrin story goes back to salamander's eye from where was generated 20 years ago and I really hope cethrin will start to make difference in SCI cases...much faster after these results.
                    www.MiracleofWalk.com

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

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                    • #11
                      Wow, this is very interesting...

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                      • #12
                        Originally posted by t8burst View Post
                        A couple questions... that seems low and also what percentage converted in the control group?
                        I will download and post the paper in the SCI (Clinical) Research forum this weekend so that members can have access.

                        Wise.

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                        • #13
                          Any move in the right direction is great news, thanks Dr. Young.
                          get busy living or get busy dying

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                          • #14
                            Here:
                            http://www.cxvascular.com/sn-archive...-cord-injuries

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                            • #15
                              "While we recognise that, given the lack of randomisation and a placebo control arm in our phase 1/2a trial, no conclusions can be made regarding efficacy, it is relevant to place the extent of neurological recovery seen in our patient cohort into context," explained Fehlings. For 2-grade or better improvement to ASIA C, D, or E, their rate of 19% at six months was 1.5 to 3-fold higher than seen in previous studies.

                              "So at the end of the day, what we can say is that it's safe, it's feasible, and the results look promising," Fehlings concluded. "The next step will be to do a prospective randomised study, and the plans for that are now in the works. We hope to initiate that within the next few months."
                              From DupeNet's link: http://www.cxvascular.com/sn-archive...-cord-injuries

                              Originally posted by t8burst View Post
                              A couple questions... that seems low and also what percentage converted in the control group?
                              Please donate a dollar a day at http://justadollarplease.org.
                              Copy and paste this message to the bottom of your signature.

                              Thanks!

                              Comment

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