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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) ???
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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
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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.
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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. -
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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 -
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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.
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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
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> 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 -
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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