Summary: Promising results from an early-phase clinical trial in MS of a monoclonal antibody were announced at the 17th Congress of the European Committee on Treatment and Research in MS, in Dublin on September 15, 2001.
The antibody natalizumab (Antegren®; Biogen Inc., Cambridge MA and Elan Corporation, PLC, Dublin), given by monthly intravenous infusions, functions by blocking the adhesion of immune cells to blood vessels and can inhibit movement of immune cells from the blood into the brain.
A six-month, early phase clinical trial involving 213 individuals with relapsing-remitting or secondary-progressive MS was conducted at 26 clinical centers in the United States, United Kingdom and Canada.
Those treated with Antegren had fewer new enhancing lesions detected by MRI than those treated with placebo, and treated patients had fewer relapses during six months of treatment. No benefit on progression of disability was detected in this short study.
The sponsors have stated that larger-scale clinical trials of Antegren, alone and in combination with Avonex® (interferon beta-1a), are planned.
Details: Promising results from an early-phase clinical trial of a monoclonal antibody that blocks movement of immune cells into the brain were announced at the 17th Congress of the European Committee on Treatment and Research in MS, in Dublin on September 15, 2001. David H. Miller, M.D. (Institute of Neurology, Queen Square, London) reported that the antibody natalizumab (Antegren®; Biogen Inc., Cambridge MA and Elan Corporation, PLC, Dublin) caused a reduction in accumulation of new enhancing lesions detected by magnetic resonance imaging (MRI) and a reduction in relapses of MS.
Background: Antegren is a molecule designed to interfere with movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier,” and into the brain and spinal cord. This monoclonal antibody attaches to a protein (called alpha 4-integrin) on the surface of white blood cells, which serves to block such immune cell movement. Antegren was discovered by Elan and is being co-developed by Elan and Biogen.
Study: Two hundred and thirteen individuals with relapsing-remitting or secondary-progressive MS were studied at 26 clinical centers in the United States, United Kingdom and Canada. Individuals were given one of two doses of Antegren (3 or 6 mg per kilogram of body weight) or placebo treatment, delivered by infusion into the vein (intravenous) once every four weeks, for six months. The primary goal of the study was to evaluate safety and to determine the impact of treatment on accumulation of new enhancing lesions detected by MRI; secondary goals included impact on MS relapses and progression of disability. The trial was double-blinded, meaning that neither the physicians nor the study participants knew who was on placebo and who was on experimental treatment.
The six-month study showed a reduction in accumulation of new lesions detected by gadolinium-enhanced MRI. An average of 9.6 new lesions were seen in the placebo group, and 0.6 and 1.2 new lesions seen in the low- and high-dose Antegren groups, respectively. Placebo-treated patients experienced 34 relapses during the six-month treatment period, compared with 19 and 14 relapses in the low- and high-dose Antegren groups. No changes in measures of disability were detected in any of the groups during the study.
Antegren was relatively well tolerated. The most common side effects included headache, weakness, and urinary tract infection. Those treated with Antegren also showed more gastroenteritis, rash, urinary urgency, back pain and fever, and infrequent allergic-type reactions.
Conclusion: This clinical trial showed promising results, but a longer trial involving greater numbers of individuals monitored clinically and with MRI will be required to determine whether Antegren, alone or in combination, might have a role in the treatment of MS. The sponsors have stated that larger trials are in the planning stages. Because Antegren functions by inhibiting movement of immune cells into tissues where they can do damage, it may have potential for use in MS and other inflammatory diseases.
Originally posted by Marc Flemming Antegren was relatively well tolerated. The most common side effects included headache, weakness, and urinary tract infection. Those treated with Antegren also showed more gastroenteritis, rash, urinary urgency, back pain and fever, and infrequent allergic-type reactions.
As painful as MS might be, I'm amazed that people will trade one problem for another. Headaches, weakness, urinary tract infection, back pain and fever are all signs of something WRONG with your body. Who in their right mind would trade one problem for a dozen bed-sentencing symptoms? Perhaps I'm missing something, but to me when I see a new drug listed with a complement of side-effects it just says to me that they're on the heels of a good idea, but haven't refined it well enough just yet. Keep working on it!
Originally posted by Sean Kelly well, not to make light of the matter, but that sounds like something someone who's never had a urinary tract infection would say..
To be honest, I really don't know what all's involved with MS and its severity.. so I guess I'll read up a bit here..
Knowing somewhat of what MS can do to someone, if you held up and presented to someone urinary tract infection in one hand and MS in the other - (and they had to choose) I'd think more people would take even the prospect of passing a kidney stone over the debilitating state that MS can provide one's existence.
Stephen Hawking has ALS (something something sclerosis). I can't say how much one is related to another - but that might put it in perspective. Of course, if you have no desire to do anything terribly physical for the rest of your life - it may not be so bad. He seems to be doing a pretty good job.
Well I love a debate. I wonder what Meds you guys are on? Ive been on Avonex, Rebif (alergic) and now Betaseron. I've had MS since 1985. I was diagnosed twice. The diagnosis I knew about was in 2001. When I went to visit the neuro I found my military medical records and there were entries about MS from 1985 to 1987. None the less I was selected to participate in the clinical trials for Antegrin but ended up not on Avonex and into a relapse.
Whats my point. Well I am tired of doing the shots. Didnt like Avonex (needle phobia), had a reaction to Rebif, and Betaseron is tolerable... I had cold and flu like symptoms with Avonex, I dont with Betaseron....but I suppose if I want to live a normal life this is the way its to be. If Antegrin once a month gives me a headache for a day or so I will be happy since the results look promissing for this treatment. As with any of the therapies...ABCRs I could without a second thought not do my shot a night or two...which I have done. Doubtful that I would neglect going to get my once a month IV. There are no guarentees BUT I will be switching as soon as this product becomes available. Guarenteed.
I myself am counting the days until this drug is available. I can take and welcome the side effects if there is a chance that my MS progression will be slowed or even stopped. Until you or someone you know has to deal with it you will never understand what it is like to have MS.
Hi! My mom has had MS since 1980. She's 67 now and lives in Romania. Doctors over there told her that Avonex, Copaxone, Betaseron, etc. are useless for her stage of this terrible disease. Therefore, when I heard about Antegren, I started to hope again for her. Does anybody have any idea when this medicine is available and how much il will cost? Thank you in advance!
"Compassionate release" (no idea what that means) is set for late 2004. Full release is set for 2005. No idea on specific dates or prices. This is in the USA based on FDA guidelines for approval. All can be subject to change or revoked if something happens in trials.
Dear Sean Kelly. You have the same name as my son so I'll cut you some slack.
I've been living with MS for about 16 years. I've only known about it for about 4.5 years. Let me tell you, comared to what I deal with, I'll take a urinary tract infection once in awhile. And if you know what the potential side affects are, you can do what is possible to reduce the risk of side affects. Like drink a ton of cranberry juice to help that urinary tract keep infection away!
MS is beyond pain. For example, I deal with fatigue (not just tired, but beyond totally exhausted), insomnia (there's a cruel joke, fatigue and insomnia), cognitive impairment such as recall (the inability to recall something from memory when you want to) and something else coming out of my mouth when I intend to say something (seeing another person in my line of site may cause me to say that name instead of another person I may be introducing). I have balance issues so I fall or walk into things alot (recently sprained my ankle so bad that it would have been a better time healing had I broke it). I have speech trouble at times and sound either drunk or like an idiot (combine with balance issues and try to convince someone that you weren't drinking). And I'm lucky compared to most. When my cousin is affected, he has trouble walking and using his hands. All of my symptoms are invisible so I don't appear to have anything wrong with me. Makes for a very frustrating life when others think of you as "healthy". Combine that with what I beleive in my mind, that I am healthy and I believe I have the ability I did before I had to deal with all of my symptoms. But, no matter what, every day I'm reminded that I don't have the energy my mind believes I do. I've had to alter my career as I was a computer professional. With cognitive impairment it was ludicrous to think that I could keep learning new technology and be able to speak to a client about it. Now I manage consultants, kind of funny when I have to remember all the names of my 120 some employees or what they do. I'm a single mother and it breaks my heart that I can't do some of the things I enjoy with my kids. Like parties. I have noise tolerance issues and a bunch of kids in one place at the same time will cause me major frustration and difficulty as well as provoke the mood swings I have. All of which adds to the depression that so easily affects most of us with MS.
Now, all that being said. I'm a pretty happy person. I try to make the most of what I have and not let all of the above drag me down. I find out what works and I do it. I realize that I can't do it all, so I don't and I'd much rather go outside and rollerblade with my kids or hit some whiffle balls with them than vacuum or do the dishes. They will sit for a little bit longer. You rarely see me without a smile on my face and I have a great sense of humor. And as grand as life is, I'm given so much to make fun of within what I deal with having MS. Most who know me really well can joke with me.
Most of us with MS know all about side affects. Everyone with MS is different and we all take a variety of medications. Sometimes it's hard to know the difference between what is a side affect, what is a symptom and what is just something else. Sometimes we don't care, it is so much easier than without our meds.
This drug - Antegren - is such a tremendous breakthrough for those of us with MS. It is only half the battle though. This will halt the progression but we will probably still face symptoms from the damage that is already done. We all still need to do what we can to promote the research into repairing the damage. Much of this will come from stem cell research. Since government funding is limited here, the funds will come from corporate and private donations. Do what you can, please, everyone...
I happened to stumble across this while searching out information on the initial Antegren study with MS. I am currently participating in the current phase of Antegren/placebo with Avonex.
When I was initially diagnosed with MS there were no treatments readily available. The symptoms were treated without any hope of treating the disease. Since that time there are now a number of MS drugs available, but the efficacy of all of them is marginal.
Many of the potential side effects highlighted in the article are things that many of us with MS deal with on a freqent basis, with or without medications.
The promise of a potential new treatment for MS and one that in the initial clinical trials proved itself through reductions in the EDSS (disability index) of many patients and in the reduction of relapses, etc.
Antegren shows promise and I am thrilled that the drug makers are working on something that will help individuals with MS continue to lead productive lives.
We have heard last fryday 12-9-03 that my daughter Martine has MS. She is 21 years old. Now we are looking for information about medicine etc. I have read about Antegren and I hope this medicine will work without to many side effects.
It is a pitty that this medicine is for sale in late 2004 or 2005. I have red your story's and it gives me hope for this new treatment. Thank you
Duub my heart goes out to your daughter and to you. Not only am i anxiously awaiting antegrens approval, my dr. seems excited about it too. Making me even more optimistic about it.
Duub ... As a newly diagnosed "family", I would highly recommend getting in touch with the local MS Chapter. I'm not sure where you are in Indiana, but the state chapter can be found at http://www.msindiana.org/
In addition, I would definitely talk with the doctor about which medication may be suitable for your daughter at this time. There a number of treatments available now which help to slow the progression of the disease - and, until a cure is found, this is one's best recourse in continuing to live a normal life.
My best wishes go out to you, your daughter and the entire family which is affected by the diagnosis. As an individual with MS, I don't want to downplay the consequences, but many of us continue to live pretty normal lives. I hope you will be able to find some answers that will help you to cope.
01-06-2003 07:09 AM
