ALS News Today Forums Forums ALS Progress Research Topics Any news from Tofersen phase III clinical trial?

  • Any news from Tofersen phase III clinical trial?

    Posted by Jean-Pierre Le Rouzic on September 5, 2021 at 3:28 am

    In March 2019, Biogen launched a Phase 3 clinical trial. Called VALOR, the study enrolled 178 people with SOD1-ALS, who received an undisclosed, fixed dose of BIIB067 or placebo for 28 weeks.

    The trial was conducted at 31 sites in North America, Europe, Australia, and Japan, and finish in July 2021.

    Currently there is no news for this study on clinicaltrial.gov.

    yet it seems a new phase III with 150 participants was started in April 2021 (NCT04856982) ???

    Jean-Pierre Le Rouzic replied 2 years, 7 months ago 8 Members · 18 Replies
  • 18 Replies
  • Les Wood

    Member
    September 7, 2021 at 1:19 pm

    I have been on the sod 1 Tofersen trial for almost five years the first person in the U.K. possibly Europe to have it I’m doing ok I was diagnosed in August 2012 my next treatment is tomorrow at Sheffield Hallamshire Hospital

    • Geison

      Member
      September 14, 2021 at 11:45 am

      Hello,
      I have the proposal to start with medication this year, this is solving the bureaucratic issues. You could share with us your experience/results with using tofersen.
      thanks

  • Les Wood

    Member
    September 7, 2021 at 1:19 pm

    I have been on the sod 1 Tofersen trial for almost five years the first person in the U.K. possibly Europe to have it I’m doing ok I was diagnosed in August 2012 my next treatment is tomorrow at Sheffield Hallamshire Hospital

  • Jean-Pierre Le Rouzic

    Member
    September 7, 2021 at 2:32 pm

    Many thanks for the answer Les!
    First person in UK, possibly in Europe? This is very impressive!

  • Amanda

    Member
    September 9, 2021 at 7:19 am

    Jean-Pierre – is this part of the same study? https://clinicaltrials.gov/ct2/show/NCT02623699

    This study, along with the other Tofferson studies, is part of what the University of Miami Pre-fALS study is involved in. There are many other sites (as mentioned in the ling) that also participate in the US and Europe.

    • Jean-Pierre Le Rouzic

      Member
      September 9, 2021 at 7:35 am

      Yes, thanks Amanda,
      The link tells “The study completed on 15 Jul 2021” and that there are no posted results.
      I can’t find any news on internet.

      • Andrew UK

        Member
        September 10, 2021 at 7:18 am

        I was speaking to Sheffield Uni this week and it was muted that an open access arrangement may be started next year prioritising more rapidly progressing patients. I will be having another conversation in Jan 2022 so will know more then

      • Andrew UK

        Member
        September 10, 2021 at 7:18 am

        I was speaking to Sheffield Uni this week and it was muted that an open access arrangement may be started next year prioritising more rapidly progressing patients. I will be having another conversation in Jan 2022 so will know more then

      • Jean-Pierre Le Rouzic

        Member
        September 10, 2021 at 11:41 am

        Thanks Andrew,

        > open access arrangement may be started next year prioritising more rapidly progressing patients.

        It’s a nice information!

  • Geison

    Member
    September 14, 2021 at 12:07 pm

    Hello,
    My name is Geison, I’m Brazilian, my family is affected by ALS family type with genetic error in SOD1. I received the diagnosis last year, the doctor who accompanies me has the proposal to start with medication this year, this is solving the bureaucratic issues. I will leave the biogen website that reports con entering the study. https://www.biogen.com/en_us/als-community-update.html

    • Angelo Venosa

      Member
      September 16, 2021 at 11:29 am

      Olá, Geison

      bom saber que um brasileiro está tendo acesso a esse ensaio clínico.

      sou portador de ELA esporádica, vivo no Rio de Janeiro.

       

      Hi, Geison

      Good to know that a Brazilian is getting access to this clinical trial. I’m a sporadic PALS living in Rio.

  • Gigi

    Member
    September 15, 2021 at 9:57 am

    You are correct Phase III of the Biogen Tofersen Trial ended in July of this year.  In April an extension of the Trial started for those patients who had already participated in the Trial, and wanted to participate, where everyone would now be getting Tofersen, even those previously receiving the placebo

    In addition Biogen has now just started a new Clinical Trial for people with fast progressing SOD1 ALS who are not symptomatic.

    Results have not been released yet.

  • Mark S

    Member
    October 14, 2021 at 4:45 pm
  • Jean-Pierre Le Rouzic

    Member
    October 18, 2021 at 3:40 am

    The results are disappointing to say the least.
    You can find my (angry) analysis on my blog:
    padiracinnovation.org/News/2021/10/disappointing-results-from-the-valor-study-on-tofersen-biib067

  • Les Wood

    Member
    October 18, 2021 at 4:50 am

    So a yes or no answer please as I can not make any sense off the different articles on Tofersen that I have read,I ask are Biogem going to continue the monthly doses of Tofersen just a yes or no answer please

    • Amanda

      Member
      October 18, 2021 at 8:20 am

      Les, have you reached out to the company or one of the clinics participating in the trials? They may be in a good place to provide you accurate information. If you do hear from them, please share the information on the forums!!
      Amanda

  • Jean-Pierre Le Rouzic

    Member
    October 18, 2021 at 5:05 am

    > I ask are Biogem going to continue the monthly doses of Tofersen just a yes or no answer please

    Sorry I have no special information other than what was posted in Biogen and Ionis’ public statement.

    However they say: “Given the high unmet medical need, Biogen will expand its ongoing early access program (EAP) to the broader SOD1-ALS population
    media.biogen.com/news-releases/news-release-details/biogen-announces-topline-results-tofersen-phase-3-study-and-its

  • Richard Maloon

    Member
    October 27, 2021 at 7:53 am

    Tofersen is an antisense asset being evaluated for the potential treatment of ALS. In the Phase 3 VALOR study, the primary endpoint as measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) did not reach statistical significance…

    accessed 10/21/2021  http://www.biogen.com

     

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