New Biogen trial - regenerating myelin

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

New Biogen trial - regenerating myelin

Postby thisisalex » Wed Jan 27, 2010 1:03 pm

Is it a coincidence that Biogen started a human trial which focuses on regenerating myelin? :)

Anyhow it just looks nice for CCSVIers also...

Biogen Idec Inc. has begin human testing of an experimental drug, dubbed BIIB033, that it hopes will take the revolutionary step of repairing some of the damage done by multiple sclerosis.

Although it is a major step to begin testing in humans, drug development is always risky and it will take years to measure the drug's effectiveness and potential side effects.

Multiple sclerosis, or MS, is a chronic, inflammatory condition that occurs when the body attacks its own myelin, the protective insulation surrounding the nerve fibers, or axons, in the central nervous system. The debilitating disease affects an estimated 400,000 people in the U.S., according to the National MS Society, but current treatments only aim to slow the disease's progression and cannot help repair damage.

Research that focuses on ways to help the body regenerate myelin is growing and scientists around the world are taking several different approaches. Damage to myelin can distort or block messages carried by axons and result in a wide variety of MS symptoms such as vision problems, limb numbness and paralysis.

BIIB033 is an antibody designed to turn off Lingo-1, a molecule that the company believes prevents myelin production in adults after axons are well covered. Blocking Lingo-1 may encourage myelin regeneration, something that occurs in healthy adults, after damage from MS occurs.

The antibody has been shown to be effective in mouse models that are accepted as being useful for mimicking the properties of MS.

The small Phase I study will include 64 healthy volunteer adults in the Netherlands, with the main goal of assessing safety and tolerability, and is expected to be completed in 2011.

The placebo-contolled study will give patients a single dose of the drug and different groups will get different amounts, a standard practice in such early trials that helps determine the optimal dose for later investigation.

The secondary goals of the trial relate to how the body processes the drug and there is no measure of its effectiveness, which is not surprising in such an early study that doesn't actually include MS patients.

MS is an attractive area of drug makers as its often requires lifelong treatment, and MS drugs brought in more than $8.7 billion in 2009 revenue worldwide, according to projections from Bernstein Research.

Biogen is mostly focused on selling MS treatments, including Tysabri and Avonex, which are expected to bring sales of more than $3 billion for 2009.

Source: Dow Jones Newswires (c) 2010 Dow Jones & Company, Inc. (27/01/10)

found at http://www.msrc.co.uk/index.cfm?fuseact ... ageid=1397
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Postby youbetcha » Wed Jan 27, 2010 2:29 pm

Very interesting.....
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Re: New Biogen trial - regenerating myelin

Postby ElMarino » Wed Jan 27, 2010 3:47 pm

thisisalex wrote:Is it a coincidence that Biogen started a human trial which focuses on regenerating myelin? :)


Coincidental with the CCSVI claims? If that's what you mean then I think that it's a coincidence, yes. I remember reading something very sletchy about Biogrn investigating blocking LINGO-1 a couple of years ago
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Postby onesickrace » Wed Jan 27, 2010 4:09 pm

i think weve all heard this somewhere or another. "timing is everything." not to be negative people, but biogen is possibly to be the biggest loser, not IF, but WHEN ccsvi pans out. what was the number i read that is made from ms drugs annually 7 billion? a year... and yes, i question everything...
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Postby jilthepil » Wed Jan 27, 2010 6:30 pm

Coincidence - I doubt it. I think they are "announcing this on the heels of CCSVI" to throw some off and to get the skeptical neurologists on their sides. It isn't hard to get someone on your side that you are already in bed with.

7 million a year is about accurate. Can you imagine?
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Postby ElMarino » Wed Jan 27, 2010 6:52 pm

No way! I hate the current system but this isn;t anything to do with CCSVI. The same team at Biogen has been working on this since 2007.

They know that universities around the world have researchers investigating axonal repair and they don't want to be left behind. Even at the fastest rate that I can imagine this drug would not be making Biogen a profit before 2016..
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Postby SammyJo » Wed Jan 27, 2010 6:57 pm

Here is the MS drug market, by drug and company, as of 2007

http://www.wikinvest.com/concept/Multiple_Sclerosis_(MS)_Drug_Market

If I was an analyst at Biogen, in charge of tracking market challenges, I think I would have found the venous stenosis research, and advised the company to have a new revenue model to fall back on.
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Postby bestadmom » Wed Jan 27, 2010 6:58 pm

This announcement is on the heels of Munschauer leaving Jacobs Neurological Institute and going to Biogen.

http://investor.biogenidec.com/phoenix. ... id=1372706

I'm sure the timing of both announcements is to trump the Buffalo study announcement and minimize it in the US press, if it gets any. This is huge business for Biogen.
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Postby ozarkcanoer » Wed Jan 27, 2010 8:25 pm

bestadmom,

I think that if the Buffalo results are positive for CCSVI, then NOTHING will trump CCSVI. Not Biogen or anything. There is no chance that "myelin repair" could trump "stopping the progression with CCSVI treatment". How many years to wait for myelin repair ? And will myelin repair actually help symptoms ? I'll bet you a $50 donation to BNAC that if Buffalo is positive then NOTHING will stop the CCSVI story. Besides which, the evidence now is MS is not just about myelin damage but gray matter damage too.

Myelin repair might be an extra added bonus after CCSVI treatment.

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Postby ElMarino » Wed Jan 27, 2010 8:33 pm

ozarkcanoer wrote:bestadmom,

I think that if the Buffalo results are positive for CCSVI, then NOTHING will trump CCSVI. Not Biogen or anything. There is no chance that "myelin repair" could trump "stopping the progression with CCSVI treatment". How many years to wait for myelin repair ? And will myelin repair actually help symptoms ? I'll bet you a $50 donation to BNAC that if Buffalo is positive then NOTHING will stop the CCSVI story. Besides which, the evidence now is MS is not just about myelin damage but gray matter damage too.

Myelin repair might be an extra added bonus after CCSVI treatment.

ozarkcanoer


From what I've read, intefering with LINGO 1 will also promote grey matter repair. Biogen aren't giving much away though. If that's the case I will be much more excited about the drug than CCSVI. CCSVI hasn't proved entirely useful for people with an EDSS like mine, on paper at least (although I don't rule out that it may with time). CCSVI would be a bit late in stopping the progression of my illness.
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Postby cheerleader » Wed Jan 27, 2010 8:43 pm

SammyJo wrote:Here is the MS drug market, by drug and company, as of 2007

http://www.wikinvest.com/concept/Multiple_Sclerosis_(MS)_Drug_Market

If I was an analyst at Biogen, in charge of tracking market challenges, I think I would have found the venous stenosis research, and advised the company to have a new revenue model to fall back on.


bingo, SJ. And if I was that analyst, I'd advise Biogen to get the inside scoop on what was going on at Jacobs by hiring an inside person. I don't think the timing of this is coincidental.
Also- gray matter damage is what Haacke and others are finding with the iron deposition. This will probably be the area to target.
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Postby bestadmom » Wed Jan 27, 2010 9:09 pm

I was in the Buffalo srtudy and had a very long meeting w/Bianca Weinstock-Guttman. I am a firm believer in CCSVI and I have it bad. We discussed her ideas about treatment.

I have a high EDSS and think fixing ccsvi is the logical first step to stop reflux, hence ongoing damage. Do I think I'll get relief from my probably permanent nerve damage? No. But I'll take knowing I'm not progressing.

Myelin repair must come second. I would prefer stem cells to drugs any day. But not everyone feels the same way and the way the fda is, maybe Biogen will get their approvals faster than the stem cell researchers.

It would be best if the iron deposits would just go away and we heal over time. Who knows if that is possible, but I guess anything is and we just don't know yet.

OC, I'm with you on the BNAC donation! I'll be writing my first check this Friday night at their fundraiser - and you will be there in spirit. Without them, CCSVI would be dead in the US, and very shortly it is going to come to life in a really big way.
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Postby SammyJo » Wed Jan 27, 2010 10:07 pm

OMG bestamon - you are the Jon Stewart of CCSVI :-)

I just clicked your link http://liberator5000.blogspot.com/

This is the first time I have read the letters "CCSVI" and giggled instead of made serious frown of concentration.

"Liberator 5000 Self Liberating MS Module" - gotta get me one of these!

Thanks for the laughs!
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Postby mangio » Wed Jan 27, 2010 10:39 pm

Bestadmom,
I know of alot of people with much disability, do you feel it is advisable
for them to try to get CCSVI testing/treatment? txs
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Postby thisisalex » Thu Jan 28, 2010 1:12 am

bestadmom wrote:This announcement is on the heels of Munschauer leaving Jacobs Neurological Institute and going to Biogen.

http://investor.biogenidec.com/phoenix. ... id=1372706


wow! this announcement just sharpens the story . If you put together the two stories, it means: they know that CCSVI is da real thing, and they have to prepare themself... with something that makes sense after liberation
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