Safety Study of BIIB033 in Subjects With Multiple Sclerosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 (anti-LINGO-1).
Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101).
For detailed information on the outcome measures and the inclusion and exclusion criteria please see entry on clinicaltrials-dot-gov.
“Exciting or not?”
CoI: I have previously consulted for Biogen-Idec the company who is developing this drug.
Yes this is exciting. Can you say why these trials always seem to start with RR, and why 'progressives' don't tend to be included at the early stages? Thanks – as always…
If this drug actually does what it says on the tin then it will change the nature of progressive MS forever. No longer will it be an untreatable disease. This drug needs to be fast tracked. I so hope that it works and meets approval.
Ha! I notice that PPMS falls in to the "Key Exclusion Criteria" for this drug. That's just swell. If anything progessive MS should be at the forefront of anti-lingo-1, not an add on years after the drug gets approval the way Fingolimod is, thus we can't have the drug for another 5 years.The trials end summer 2012. Does that mean it will be on he market in a few years?
Re "The trials end summer 2012. Does that mean it will be on he market in a few years?" Unfortunately, not this will only be the end of the phase 1b programme. The drug will need to go through phases 2a, 2b and 3 before be licensed. There are many obstacles along this path; it may not work, it may induce antibodies with severe infusion reactions, it may a serious systemic side effect all of which can derail its development. Let's hope it gets through the pipeline and works in both relapsing and progressive MS.
The first trial was a safety trial, and I could understand why they might not want to include progressives when the drug is not yet even known to be safe in humans.The last group (group 8, who were receiving the highest tolerated dose from groups 1-7 at a faster rate – in 1 hour rather than 3 hours) received the drug in September 2011. The first group at a very small dose received the drug in October or November 2010, with each subsequent group at a higher dose roughly a month later. There are then 4 months of follow-on exams for each of the 8 groups, including a follow-up MRI 3 months after dosing to look for changes in brain lesions. So all the data is collected by mid-January 2012, then there is data analysis, initial findings and review of the findings before the trial ends in summer 2012 and results are officially made available. The second trial is an efficacy trial. I would expect that once they have sufficient phase 1 data to suggest appropriate doses and dosing rates, they will put together the criteria for the phase 2 trial.
I think many people who got an email about the survey have ignored it. The URL of the first post was '…are-you-up-for-having-lumbar-puncture.html': If somebody has not read the blog the response to this URL would be 'NO'. Re 'Sorry to be blunt' – I agree with both points.Re 'You need a better way of communicating with the MS community' – For a project like this, the MS Society ought to send an email on your behalf. Their website says they have 38,000 members and @mssocietyuk has 6873 followers on TwitterIf you have a small self-selected group of respondents, the survey results won't mean anything.But do you really need such a survey? The trial is to have only 60 people. I'm sure neurologists could identify candidates and convince them one-to-one.
How is it delivered in trials?Pill?InjectionIV?
IV injection you can check on clinical trials. gov
the trial drug was administrated bt IV…although no one knew who was recieving the drug it quickly became clear…the affects of the drug were short of a miracle…unbeliwveable really…cannot wat to go to phase II
Craig, I was asked to take part of the Phase II trial in Northern California. Great news but a bit undecided. They plan on starting in the next five months. I would like to talk with you if you have a couple of minutes.
Thanks for posting this information that Phase II are going forward.Good luck with your participation.
I think that all of us would thank you if comments about experiences in this trial are posted…they mean positive energy for us¡¡¡ Craig, thank you for share your experience¡¡¡
i was in the last group that got the largest dise of this drug by IV. Which in an hr the drug was working on my body. although noone knew who was getting the drug…it was apparent who did. the results speak fir thenselve…i cannot wait for phase two to start.
What different did you see
my eye sentivity went away all my numbness went away.
How could the drug work that fast? I hope Phase II goes well
This is probably fake. There's no way a miracle of this sort can happen in a phase 1 trial.
Craig — the results were recently posted and no symptoms improvements were reported. It's really mean of you to lie so blatantly.
Sure? I think that they did not reported nor improvements nor no improvements. Just about safety issues because that was the purpose of the phase I
If this is real, this is a revolution…where can apply for this study?
In the UK the trial is being done in acute optic neuritis. The London site is at Moorfields and the principal investigator is Dr Gordon Plant.
I would be a guena pig for a trial if it would help find answers for MS
So check out clinical trials..gov to see if you are eligable
Thanks for the replay. Do you Know if it also will be able for PPMS?
Don't see why not however it is only at the experimental stage.You can see trials at www. clinical trials.gov
is there anymore news on this? I dont have MS but have an acute demyelinating disorder caused by toxic damage, Im hoping this may prove to be helping for people in my condition also
Not yet reported.
Anynews on this? I Know that Biogen will publish sth on late 2014 about Optical Neuritis and on late 2015 about RRMS, but anybody knows sth about how is doing the phase II? Any experience like Craig's?I'am looking forward Phase III to arrive¡¡