Earlier Natalizumab Trial

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

Postby Observer » Mon Dec 13, 2004 2:31 am

Harryz

Just a subtle but important point: my Oxford Dictionary defines information as 'facts told or heard or discovered.' Rumours of an 18-month drop in efficacy, for which I nor anyone I know CAN FIND ANY SUBSTANTIATION, do not qualify as facts and as such, are not information. Recognize them for what they are - RUMOURS. If you or anyone has data supporting the 18-month efficacy drop rumour, either in theory or fact, please post it.

And on Cafepharma, its as likely as anywhere to be disinformation by Tysabri competitors.


I fully agree with you, time will tell, and I suspect the wait is getting shorter as I write this. The AFFIRM trial was officially over on 30 November (this from the BIIB R&D Day webcast of 30 Nov 04 - a quote from Al Sandrock, VP of BIIB).

I wonder how long it will take them to assemble the data, analyze them, get them to the FDA and release it. My guess - end January Press Release. But I hope sooner. I'll certainly be revisiting this thread when those data are released - whether I'm right or wrong.

As for a preview, note that in the 6 month Phase 2 trial there was a 50% reduction in relapses with Tysabri relative to placebo. In the 1-year Phase 3 study, there was a 66% reduction in relapses relative to placebo. I like that direction. Wanna bet that the 2yr data are >70% reduction? I would. Cannot wait. And the EDSS data?
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Postby HarryZ » Mon Dec 13, 2004 10:10 am

Observer,

If you or anyone has data supporting the 18-month efficacy drop rumour, either in theory or fact, please post it.

In time.
And on Cafepharma, its as likely as anywhere to be disinformation by Tysabri competitors.

Then there is just as much chance as what these people are talking about is very true!
I wonder how long it will take them to assemble the data, analyze them, get them to the FDA and release it. My guess - end January Press Release. But I hope sooner. I'll certainly be revisiting this thread when those data are released - whether I'm right or wrong.

Usually it takes 4-6 months to assemble this data so I'm thinking maybe in April. But one never knows for sure.
As for a preview, note that in the 6 month Phase 2 trial there was a 50% reduction in relapses with Tysabri relative to placebo. In the 1-year Phase 3 study, there was a 66% reduction in relapses relative to placebo. I like that direction. Wanna bet that the 2yr data are >70% reduction? I would. Cannot wait. And the EDSS data?

I know it's easy to build up expectations on something that you hope is going to be very good. But in view of the past record of MS drug research which has been anything but , let's take it one step at a time and wait for the science.

Harry
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Postby Observer » Mon Dec 13, 2004 7:08 pm

Harryz

The companies have already stated the AFFIRM trial will be presented at AAN in April, so your April bet is probably pretty safe.

As for compiling the data, they submitted the 1yr data to the FDA in Dec 03. The AFFIRM trial was 108 weeks (I think this is the correct number) and officially ended on 30 Nov 04. That means they had ALL the 1yr data approximately 30 Oct 03, and submitted it to the FDA in December 03. So maybe we'll see the results earlier - 2 months - could be late January.

Regarding the 18-month efficacy rumour, and your claim that the supporting data will be given 'in time,' why spread the rumour prior to having the data/proof? Why not wait 'in time' before spreading such nonsense? I just don't understand.


Then there is just as much chance as what these people are talking about is very true!


You must be joking! Again, don't spread the rumour unless you can back it up with facts of some kind.

I know it's easy to build up expectations on something that you hope is going to be very good. But in view of the past record of MS drug research which has been anything but , let's take it one step at a time and wait for the science.


Past MS research has nothing to do with the facts that I presented from the Tysabri P2 and P3 trials. The decrease in relapse rates in the 1 yr trial compared to the 6 month trial is a fact. One person might want to draw a correlation on that basis, another might not. No right or wrong here, just individual choice. Agree to disagree, and let each reader decide how they feel.

And as far as taking it one step at a time, and awaiting the science, I wish those talking of an 18-month efficacy dropoff would follow that advice! On the one hand, you suggest not building up hopes, but on the other hand you freely dash hopes by quoting an anonymous poster with no data who talks of an 18-month issue. OK to be skeptical, but not OK to be optimistic? Balance?

Harryz, we seldom agree except on the issue that, certainly, more data are needed. I obviously think I'm right, but the issues we are discussing are not black/white and I also recognize (based on my past history) that I could be partially/completely wrong. I'll leave it at that, and give you the last word.
Last edited by Observer on Mon Dec 13, 2004 9:20 pm, edited 1 time in total.
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Postby HarryZ » Mon Dec 13, 2004 9:15 pm

Observer,

Regarding the 18-month efficacy rumour, and your claim that the supporting data will be given 'in time,' why spread the rumour prior to having the data/proof? Why not wait 'in time' before spreading such nonsense? I just don't understand.


You know, sometimes people come across information that can't be verified at the time. Or sometimes they are given information in confidence. That doesn't make it "nonsense". Yes rumors are out there, in fact there are a lot of rumors out there about Tysabri. Some rumors will end up in the garbage can but others will become fact. Don't get so impatient! It will all work out in time.

You must be joking! Again, don't spread the rumour unless you can back it up with facts of some kind.


A link to a website that appears to be drug company sales reps who are making comments on Antegren and Biogen. Nothing more, nothing less. Believe what they are saying or don't.

Past MS research has nothing to do with the facts that I presented from the Tysabri P2 and P3 trials. The decrease in relapse rates in the 1 yr trial compared ot the 6 month trial is a fact. One person might want to draw a correlation on that basis, another might not. No right or wrong here, just individual choice. Agree to disagree, and let each reader decide how they feel.


I didn't say that it did but past MS research has certainly influenced my thinking and the lack of trust that I have in drug companies. You don't have that same feeling that I have about this and that's fine. If you want to believe everything that Biogen has been telling us and accept it as gospel, then that's fine as well. But there are others out there that don't share that same belief.

On the one hand, you suggest not building up hopes, but on the other hand you freely dash hopes by quoting an anonymous poster with no data who talks of an 18-month issue. OK to be skeptical, but not OK to be optimistic? Balance?


I think you are reading something into my posts that doesn't exist.

Harryz, we seldom agree except on the issue that, certainly, more data are needed. I obviously think I'm right, but the issues we are discussing are not black/white and I also recognize (based on my past history) that I could be partially/completely wrong. I'll leave it at that, and give you the last word.


Yes we certainly have our disagreements and indeed they are based a lot on past experience. And you are very right when stating that drug issues are anything but black and white.

Harry
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Postby optimist » Tue Dec 14, 2004 9:05 am

Harry Z

Is the webcast from John Hopkins U about Tysabri that you refer to in your post (Sun. Dec 12, 2004 6:53 am) available to the public? I would love to hear what the MS docs have to say. What is the date of the "mini conference" ? I don't suppose they will have seen any of the 2 year data at the time of the conference will they?
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Postby HarryZ » Tue Dec 14, 2004 11:19 am

Optimist,

The John Hopkins webcast is tomorrow, Wednesday Dec 15 and is sponsored by the Consortium which is group of MS Professionals. I believe that you have to be a member of this group to get on to the conference but don't know for sure. A contact of mine is a member and she will be logging on to find out if anything interesting takes place.

Some of the docs in this group are very active in the treatment and research of MS. They have access to a whole lot more information than we do about Tysabri. Whether this includes info from Biogen I don't know but I believe that Consortium members have been talking to Biogen reps.

I'll let the board know what kind of information is made available.

Harry
Last edited by HarryZ on Tue Dec 14, 2004 7:13 pm, edited 1 time in total.
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Postby optimist » Tue Dec 14, 2004 6:27 pm

Harry Z,


Thanks for the reply. I'll be looking forward to any information you receive following the webcast.


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Postby HarryZ » Tue Dec 14, 2004 7:42 pm

I was over at the Multiple Sclerosis Sucks forum tonight and read about a recent US/Canadian MS Society sponsored video presentation on MS. The video was made by the Cleveland MS Clinic and the MS doc conducting the presentation was asked about Tysabri. He stated that the concept of the drug was quite amazing but went on further:

"When asked if he was going to be using it in his practice, he replied that he probably would not for at least a year, until he saw how people responded to it. He stated that it was not designed to take the place of a CRAB med and that if someone was already on one and doing well, they should not consider Tysabri as an alternative because it was not a sure bet they would do any better on Tysabri than they were doing on their CRAB med"

So despite all the data that has been presented by Biogen, there are MS docs out there that are being cautious about it and hold a "wait and see" attitude. If I had the name of the doc I would gladly post it but it was not mentioned in the note.

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Postby Observer » Tue Dec 14, 2004 8:53 pm

Harryz, how about some GOOD news for once. I'll start it off:

http://www.nctimes.com/articles/2004/12 ... _11_04.txt

______________________________________________

A patient's story

By: BRADLEY J. FIKES - Staff Writer

Treating multiple sclerosis, or even diagnosing it, isn't easy. The disease can produce a variety of symptoms that can be mistaken for other conditions.

Shari Ferko, a multiple sclerosis participant in a Phase II trial of Tysabri, knows this from personal experience. She had her first symptom, a loss of sight in her left eye, in 1979. But she wasn't diagnosed with multiple sclerosis until 1990.

To treat her vision loss, Ferko was given the drug prednisone, and her vision temporarily improved.

"In 1984, I had another bout with my vision problem and numbness with my left leg," said Ferko, who was living in Tennessee at the time. "The doctor said I probably had a pinched nerve, but it never went away."

During the rest of the decade, Ferko's balance and coordination deteriorated, making walking difficult, and she experienced problems with bladder and bowel control. She began to fatigue easily.

As the symptoms worsened, Ferko was forced out of jobs, including one as a hospital nurse, and later at a medical clinic.

Ferko continued her prednisone treatments during the early 1990s, until they were no longer effective. Her prognosis was bleak.

"I was told I would be using a cane in two years, a wheelchair in five years and be dead in 10 years," Ferko said. "My kids were 7 and 8. I wouldn't see them graduate from high school, go on to college or have kids of their own."

Things changed for the better after Ferko moved to Dallas. She contacted the Dallas chapter of the National Multiple Sclerosis society. In 1998 she found J. Theodore Phillips, a neurologist who had developed expertise in multiple sclerosis since the early 1980s.

"It was just like night and day. He knew all about MS," Ferko said.

Phillips suggested she join a Phase II study of Tysabri. In the double-blinded study, neither patients nor physicians knew who was getting the drug or a placebo. Later, she was placed in an "open label" study where both Phillips and Ferko know she is getting the drug.

Today, Ferko's health has stabilized. She works today at a desk job as a legal nurse consultant.

"I did live to see my daughter graduate from college. I did live to see my son's first child born, and I get to baby-sit, so that works out really well," Ferko said "Ö If this is the kind of life I can have, I'm really happy."

Ferko advises those diagnosed with multiple sclerosis to make finding a knowledgeable doctor their highest priority.

"This is not the death sentence that it was 20 years ago. You can live a full life, but it's important to get involved with a physician that knows MS," she said.

The San Diego chapter of the National Multiple Sclerosis Society can be contacted on the Web at (www.mssd.org) or by phone at (858) 974-8640.

_____________


Uhh, I guess there are some MS Docs that are not so cautious about Tysabri. I also suspect that they're in the majority (IMHO). We'll see.
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Postby Observer » Tue Dec 14, 2004 9:02 pm

And here's another story, with an MS Doc who is upbeat about Tysabri. I'll just post the link this time, and I note that the Doc's name and location are clearly indicated, if anyone is interested.


http://www.nctimes.com/articles/2004/12 ... _11_04.txt


and another, confirming that Dr. Phillips is indeed keen on Tysabri

http://www.forbes.com/technology/scienc ... iever.html

with an excerpt


"Tysabri, however, is so good that it may steal sales from Avonex. What's more, while the new drug is more expensive--$23,000 a year, versus $18,000 for Avonex--Biogen's need to split the profits means Tysabri's opportunities may not make up for lost Avonex sales. Ted Phillips, a specialist in MS at Texas Neurology who led some of the Tysabri trials, says he plans to mostly use Tysabri alone as the new first-line weapon against MS. His reason? Even by itself, Tysabri is twice as effective as any of the existing drugs alone. On the other hand, Geoffrey Porges, an analyst at Sanford C. Bernstein, surveyed neurologists before the drug was approved. 60% of the doctors he surveyed will use the combination therapy in most of those patients whose disease is not stable."


'Nuf said.
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Postby HarryZ » Tue Dec 14, 2004 9:17 pm

Observer,

Harryz, how about some GOOD news for once. I'll start it off:


Why are you equating a MS doc, who is speaking to an audience of MS professionals and gave his opinion about Tysabri, as "bad news"?

Like you eagerly demanded in a previous post, you wanted "balance". This is balance. You quote the press release stories and Biogen and I quote some professionals who work with MS almost every day of their lives. The readers of this and other MS forums will decide for themselves which articles are more appealing to them.

Harry
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Postby Observer » Tue Dec 14, 2004 10:58 pm

You obviously have NOT read the links, as none are from Company press releases. Or is there some grand conspiracy between Biogen Idec and The North County Times of San Diego? Good grief!

Why are you equating a MS doc, who is speaking to an audience of MS professionals and gave his opinion about Tysabri, as "bad news"?


I never said it was bad news, I just said how about some good news. I do not understand why you suggest this, but perhaps you should re-read my post. [And please don't put "bad news" in quotes as if I said it - I most certainly did not. Thank you.]

I actually thought it was cautious, as you suggested:


So despite all the data that has been presented by Biogen, there are MS docs out there that are being cautious about it and hold a "wait and see" attitude. If I had the name of the doc I would gladly post it but it was not mentioned in the note.



As for the intent of my posts, I simply posted links to articles which named MS Doctors who were upbeat on Tysabri, and willing to use it now. You had posted something about a more cautious Doctor. I thought my posts brought a healthy balance to the discussion. What's wrong with that?

Agree to let the readers decide, but methinks they need to hear both sides of the story.
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Postby HarryZ » Wed Dec 15, 2004 7:25 am

Observer,

I never said it was bad news, I just said how about some good news. I do not understand why you suggest this, but perhaps you should re-read my post. [And please don't put "bad news" in quotes as if I said it - I most certainly did not. Thank you.]


I guess that I assumed incorrectly, my apologies!....when someone states "how about some good news" in replying to a previous post, one might think that the previous news was "not so good"!

As for the intent of my posts, I simply posted links to articles which named MS Doctors who were upbeat on Tysabri, and willing to use it now. You had posted something about a more cautious Doctor. I thought my posts brought a healthy balance to the discussion. What's wrong with that?


Now we are agreeing on something....a nice change! BTW, in the Multiple Sclerosis Sucks forum, the MS professional who answers a number of questions for readers over there stated that she spoke to about 18-20 MS docs in her circle of work and all of them stated that they would not be rushing into the use of Tysabri until far more data was made available and the drug proved itself in general usage.

Agree to let the readers decide, but methinks they need to hear both sides of the story.


Absolutely!

Harry
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Postby Observer » Wed Dec 15, 2004 10:25 am

Harryz

Lets just hope they get the 2 yr data out quickly. Whatever it says, I'm sure we'll find something to disagree about. :wink:
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Postby HarryZ » Wed Dec 15, 2004 1:29 pm

Observer,

Lets just hope they get the 2 yr data out quickly. Whatever it says, I'm sure we'll find something to disagree about. :wink:


But of course...that gives everyone on the board something to look forward to :D

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