Any news from Tofersen phase III clinical trial?

[Jean-Pierre Le Rouzic]

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) ???

[Les Wood]

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

[Les Wood]

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]

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

[Jean-Pierre Le Rouzic]

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

[Amanda]

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]

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]

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]

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]

Thanks Andrew,

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

It’s a nice information!

[Geison]

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]

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]

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.

[Author]

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