I've been waiting for two years for the anti-lingo phase 2 study to start, phase 1 seemed very promising and I probably had a spot in the phase 2 study. My doctor and I were very enthusiastic about it, and he was going to lead a local study center.
Found out last week that it looks like the 'entire' study is filled, that the majority of the spots Biogen planned for have already been filled by European centers as at least 8 of the NA centers (including mine) couldn't get all the t's crossed and i's dotted between them and Biogen in time.
So instead of being in a promising trial we have to sit back and wait for the drugs approval in years because paperwork kept getting passed back and forth between the centers and Biogen.
Yea, I am a little mad and depressed over this one.
Anti-lingo study - lawyers and bureaucrats suck!
- CureOrBust
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- Location: Sydney, Australia
Re: Anti-lingo study - lawyers and bureaucrats suck!
I know that in Australia, we can get access to specific unapproved medications through the govt. dept that is probably our closest equivalent to the FDA; although not so involved with catching criminal activity. The scheme is called the special access scheme, and involves a private and specific application by a doctor for your personal importation and use of the unapproved medication. Normally its used for life threatening diseases, but I have used it twice so far for MS treatments.
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Re: Anti-lingo study - lawyers and bureaucrats suck!
For those interested, here is a link to the recent article "Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033"
http://nn.neurology.org/content/1/2/e18.full
http://nn.neurology.org/content/1/2/e18.full
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Re: Anti-lingo study - lawyers and bureaucrats suck!
Also for those interested in participating in the Phase II study, it appears they are accepting participants:
"Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (SYNERGY)"
http://clinicaltrials.gov/ct2/show/stud ... ocs=Y#locn
"Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex (SYNERGY)"
http://clinicaltrials.gov/ct2/show/stud ... ocs=Y#locn
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