Efficiency of Antegren

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Efficiency of Antegren

Postby tarren » Wed Mar 17, 2004 3:13 pm

Hey! I just read an article that stated that Antegren was 30% more effective than placebo. I thought it was much more effective than that? Has there been new information released regarding how effective it is? I know the CRAB's are about 30% effective. Someone PLEASE tell me this was a typo and that it is in fact better than that!!!
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source of article

Postby VirtuallyFine » Wed Mar 17, 2004 4:34 pm

hi tarren,

who / what was the source of this article? where did you come across it?
< March 20, 2004 = I want my life back *sigh*
> March 20, 2004 = ...day one on alertec = getting my life back? *grin*
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Postby Ptwo » Thu Mar 18, 2004 6:21 am

The reporter may just not have been up to speed on the facts. So far the only data is from the phase II trial which showed an 85-95% decline in lesion activity and a decline in relapse rate of 45-75%.

Here's what Elan had to say about the phase III trial, The decision to file a Biologics License Application (BLA) was made after discussions with the FDA of one-year data from the two ongoing two-year Phase III trials in MS. The companies are committed to completing the two-year trials. To protect the integrity of the trials, the companies are not disclosing the one-year data at this time.

So the reporter had no info about phase III.

Peter
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Postby finn » Thu Mar 18, 2004 1:10 pm

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 7:38 am, edited 1 time in total.
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Postby tarren » Thu Mar 18, 2004 2:34 pm

Thanks for finding the article. I have searched half the day and couldn't remember where I saw it. It did concern me a little, seeing that I have also heard here and there that the Phase III trials were not as good as originally hoped. But this is all hear say and until the results are officially published, I guess we will all have to wait and see. :-)

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Postby HarryZ » Wed May 26, 2004 5:48 pm

Tarren,

I'm new to the board today and just starting to find my way around. I have been following MS research for about 40 years now so I have some idea of what is going on in the world of MS medicine.

I'm viewing the info that has been released on Antegren with a lot of caution. Elan and Biogen stopped their trial in Ireland because they said the results were so good that they wanted to apply early for FDA approval. They aren't releasing their data from the Phase 3 trial because they have stated that they don't want to influence the data from the remaining trials. Well, the very fact that they stopped their trial and are applying a year ahead of schedule for FDA approval has already likely skewed the data that still hasn't been finalized from other centres. Antegren has been undergoing multi-centre trials and you can imagine what kind of possible influence this news will possibly have on those patients.

I've communicated with a few people who are very knowledgeable in MS research and they don't like what Elan and Biogen are doing here. Biogen, who also makes Avonex, have been taking a real "licking" in the CRAB drug market in the past year or so and I would hope they are not pressing for early FDA approval just to improve their bottom line.

I guess time will tell.

Harry
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Postby lottydotty » Fri May 28, 2004 12:34 pm

I agree about the bottom line theory. If any of you watch the stock market Biogen Idec stocks have steadily increased since January. Elan's aren't looking so great but didn't they file bankruptcy or was it that they sold the rights to Biogen to try to keep their company afloat?
So much hype about it. It reminds me of the Rebif hype. Then it turns out it effects alot of peoples liver enzymes so bad that they have to stop taking it. That's what happened to me. I do have hope wether it be Antegren or goat serum or whatever.
Just don't forget pharmacueticals are in it for the money.
We're in it for the cure.
MS is the gift that keeps on giving.
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ANTEGREN example

Postby pleezbgood » Tue Aug 31, 2004 12:16 pm

It is best to go directly to the source for information, rather than relying on conjecture and intuition. The following is an example of the power of ANTEGREN.


P06.082] Single-Patient Study for the Emergency Use of Natalizumab (Antegran) in the Treatment of Pediatric Multiple Sclerosis

Shehzad Choudry, Shane Maxwell, Douglas R. Jeffery, Wisnton-Salem, NC, Michael Panzara, Boston, MA, E. Steve Roach, Winston-Salem, NC

OBJECTIVE: To assess the safety and efficacy of monthly IV doses of natalizumab (Antegran) administered to a 5-year old patient with aggressive multiple sclerosis (MS) BACKGROUND: Pediatric MS is uncommon and there have been no controlled trials of standard immunomodulatory therapy. The present report describes a 5 year old patient with onset at 18 months treated with natalizumab (Antegran) as rescue therapy. Antegran is a humanized monoclonal IgG4 antibody to the a4 integrin. The patient had an uncomplicated aseptic meningitis at 15 months. Three months later she developed a right hemiparesis and was diagnosed with acute disseminated encephalomyelitis. MRI scan showed multiple white matter lesions. Three months later she suffered a partial transverse myelitis and her MRI scan showed more new lesions. She then developed ataxia and subsequently a bilateral optic neuritis accompanied by further changes on MRI. Oligoclonal bands were negative but extensive evaluation failed to reveal a more likely diagnosis and the diagnosis of MS was later confirmed by brain biopsy. She was started on interferon beta-1a and titrated up to 21 mcg IM twice weekly. Despite treatment she continued to show evidence of aggressive inflammatory disease and required frequent IV methylprednisolone (MP) and eventually cyclophosphamide. She tolerated treatment poorly and progressed despite therapy. She suffered a severe right optic neuritis with complete loss of vision in her right eye and a cervical transverse myelitis. She was treated with IV MP and plasma exchange with only minimal recovery. At this point she remained quadriparetic and blind from her MS. She began treatment with Antegran on an emergency basis approved by the FDA and the IRB. DESIGN/METHODS: Given her age and weight, she was initially dosed at 3 mg/kg monthly for four months and later at 6 mg/kg to achieve adequate drug serum concentrations. Therapeutic effect was assessed by MRI, relapse frequency, and EDSS. Safety assessments included exams, vital signs, adverse event monitoring, and laboratories as well as monitoring pharmacokinetics. RESULTS: Following 29 weeks of therapy she has continued to improve clinically and is now fully ambulatory. Vision remains severely impaired with only partial recovery of vision in her right eye. MRI scans have shown a marked reduction in gadolinium enhancement and in new lesion formation with minimal disease activity. She developed an apparent IFN related hepatitis resulting in the cessation of IFN therapy. No elevation of liver function tests or other drug related adverse events has been apparent on Antegran alone. CONCLUSIONS: The use of Antegran has been safe and effective for 29 weeks in a five year old patient with aggressive MS who failed to respond to standard immunomodulating therapy. Supported by: Biogen, Idec, and Elan Pharmaceuticals.
Category - MS and Related Diseases
SubCategory - Therapeutics

Thursday, April 29, 2004 3:00 PM
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Re: ANTEGREN example

Postby HarryZ » Tue Aug 31, 2004 1:02 pm

Hearing recovery stories like this involving a 5 year old that has been diagnosed with MS is quite heartwarming. But at the same time one would have to agree that the number of illnesses that this child has experienced in the first 5 years of life have been devastating. It certainly isn't what you would expect from the average MS patient. (if there is such a classification)

While Antegren appears to have dramatically helped this child there are a number of individual cases where certain drugs have had excellent results for some MS patients...Novantrone, cyclophosphomide, stem cell transplants, plus some others still in experimentation. The real test of Antregen (providing it gets FDA approval) will come when a lot of MS patients start to use it, outside of the clinical trial atmosphere. Only then will we really start to know how effective it will be for the general MS population.

Harry

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Postby lottydotty » Tue Sep 07, 2004 10:44 am

Conjecture and intuition. Add a business sence to that and you can see a bigger picture. Will Antegren help? Sure! It will help some people but not everybody. That's a fact.
The question I have is at what cost? I'm not referring to the financial aspect but the quality of life. With all the side effects and all.
Truely, there's only one way to find out. Give it a try. Roll the dice and hope for a good outcome!
That's basicaly what we are all doing with all the med's. You know, here try this. If it doesn't help come back and I'll prescribe you something else. And so on, and so on.
Best wishes for everybody no matter what meds or diseases the are dealing with. Always listen to your own body.
MS is the gift that keeps on giving.
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Postby HarryZ » Tue Sep 07, 2004 11:57 am

Lotty,

You pretty well summed it up and told it like it is! There's not much more that can be added to your very true words.

Take care.

Harry
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I was in the Antegren studty - good stuff!

Postby perfectkittysmom » Sat Sep 18, 2004 7:54 pm

I was in the 2nd stage of the Antegren study and did very very well on it - better than anything else I ever tried. When I was on it, I immediately got sensation back in my leg, I stopped slurring my words, my EDSS score went down, my comprehension and attention scores went up, and, over the 2 years I was in the study, I did not develop one new lesion.

Antegren works in a fundamentally different way than the other meds - it works by preventing the myelin antibodies from getting thru the blood brain barrier where they wreak havoc on us. Rather than turning down your immune system (or spectrums of it) or being a steroid or decoy for myelin antibodies, it instead works by preventing transmigration of antibodies (lymphoctyes and leukocytes) thru the BBB. That means, we hope, less long term risks to treatment and I for one can not wait till it comes out b/c I have been on Betaseron since the study stops, and, at least for me, it doesn't work nearly as well and I have tons of side effects (and bruises....)

Cost wise it is expected to be about the same price as the other ABCs, but I heard Biogen has a fund to pay for meds for patients that don't have rx coverage, if that helps. Also those w/out rx coverage can often get their meds covered on their regular health insurance.

If it helps anyone to hear from someone who has been on it, I think this stuff is awesome, and everyone I know from our study can't wait to get back on it.
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Postby finn » Sun Sep 19, 2004 4:06 am

Sorry, time to leave the board.

-finn
Last edited by finn on Sun Aug 28, 2005 10:03 am, edited 1 time in total.
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Re: I was in the Antegren studty - good stuff!

Postby HarryZ » Sun Sep 19, 2004 5:47 pm

Perfect...mom,

From what I have read and been told, Antegren doesn't do very much for one's current MS symptoms. I'm wondering if you may have enjoyed a remission of your MS at the same time while being on the study.

Whatever, the important thing is that you are feeling much better and have your life back.

Harry
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Postby Ptwo » Sat Oct 02, 2004 4:06 am

I went to an ms society dinner this week where the neuro giving the talk for the evening mentioned that patients involved in the phase II trial had experienced rapid progression since going off the drug. He said there's an article in the New England Journal of Medicine but I've yet to find it.

How has it gone for you Perfectkittysmom since ending the trial?

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