Phase II study of oral Fingolimod(FTY720) in MS results

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Phase II study of oral Fingolimod(FTY720) in MS results

Postby MSUK » Wed Jan 06, 2010 12:54 am

Phase II study of oral Fingolimod(FTY720) in multiple sclerosis: 3-year results http://tinyurl.com/6bl54w
MS-UK - http://www.ms-uk.org/
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Postby scorpion » Wed Jan 06, 2010 12:58 pm

These are very encouraging results!!!! Thanks. Tony
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Postby ElMarino » Wed Jan 06, 2010 6:21 pm

0.2 annual relapse rate. Pretty good! Thanks.
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Postby sou » Thu Jan 07, 2010 5:56 am

Of the 250 patients who entered the extension study, 173 (69%) continued to month 36.


What happened to the rest 77? Did they quit because they found the drug not effective for them? If so, the results are not reliable.

Fingolimod is an immune suppressant that prevents lymphocytes from leaving the lymph nodes. How useful lymphocytes bound to the lymph nodes are, is something I can't understand. We already have powerful immune suppressants available.

Why yet another?

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Shortest joke: "We may not be able to cure MS but we can manage its symptoms."
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Postby scorpion » Thu Jan 07, 2010 6:22 am

Fingolimod is not just another immune suppressant Sou. Fingolimod may be the first oral drug people with MS can take to alter the course of the disease. It sure beats daily injections and the relapse rate, if the numbers prove correct, are promising.
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Postby sou » Thu Jan 07, 2010 8:32 am

Hi.

Isn't azathioprine yet another oral drug often used in MS with similar immune ablating properties? I think that there are cyclophophamide tablets available, too, but I am not sure.

Is approval and other bureaucratic procedures really important? What does fingolimod have that other immunosuporessants don't? What's the difference between killing T cells and keeping them inside the lymph nodes?

I don't want to argue about MS being autoimmune or not, but immune suppression has not shown the expected results, like it has done with EAE in mice. If it were the answer, we already have fantastic immune ablating pills. They are generally used as a last resort because of their bad effects on the ability of the body to fight cancer and infection. And fingolimod is no different in this.

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Postby dignan » Thu Jan 07, 2010 12:42 pm

sou, the thing about fingolimod (other than the oral thing) is that if confirmed in phase 3 trials, its efficacy is good compared with other MS treatments, either approved or commonly used off-label (like azathioprine or cyclophosphamide). I guess it's efficacy could be in the same ballpark as tysabri or novantrone, and not as a good as campath, which isn't yet available. All of these immune suppressants have side-effects, and are not going to be a cure, but if they help some people who aren't helped by other treatments, I think they are worth having around.
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Postby Summer55 » Thu Jan 07, 2010 5:29 pm

sou wrote:Of the 250 patients who entered the extension study, 173 (69%) continued to month 36.

What happened to the rest 77? Did they quit because they found the drug not effective for them? If so, the results are not reliable.

sou(r)


Hi Sou, that's definitely a good question - why did they quit the trial? There's many reasons that a person would not finish a trial that is 36 months long. I wonder if that information is posted somewhere - perhaps with the official trial results?

I've quit a drug trial before, but not for that reason. When I quit the trial that I was in, I asked the trial nurse if it was common for people to drop out. She said that in every trial, that will be the case, and always for a wide variety of reasons.

So, I wonder what percentage of the 77 people that quit did it to go onto other, approved, treatments.... what percentage quit because of side effects..... what percentage quit because they moved cities during that time period..... what percentage quit for personal reasons.... what percentage quit for religious reasons....

If you do some research on it to get some real answers, please let the rest of us know!!!!
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campath

Postby leetz » Thu Jan 07, 2010 8:18 pm

my campath story is under the CAMPATH forum.......no results as of yet...good or bad!!! i have been told"these things take time".........

LEETZ
GOD BLESS.... CCSVI treatment Dr. Siskin great doc....symptom's improved for about 3 week's (gait, balance, spasticity) now back to square 1...
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Postby sou » Fri Jan 08, 2010 5:16 am

These things take time... I am sick of kindergarten-style excuses from "the experts". When we say "time", this can vary from 1 ms to 1 trillion years, or more.

How much time?

Keep faith! You should be ok before dinosaurs reappear on Earth. Normally, scientists should try to give answers to ever lasting questions. Instead, I see them trying to find new excuses.

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Postby TickledPink » Fri Jan 08, 2010 7:06 am

I just happened on this thread quite by chance as a link to it came in my google alerts email.

I can tell you from first hand experience that Fingolimod (FTY720) has been my "miracle drug". I'm in the Phase III TRANSFORMS clinical trial where 2 different doses of Fingo were pitted against Avonex. All participants had to take 1 pill a day and one IM shot once a week. There was no placebo involved -- you either got real Avonex or one of the 2 doses of the real Fingolimod.

I entered the study on 8/20/07 having had MS for 8 years and only taken Copaxone to that point. For 2 years immediately prior to the study I had been relapsing every 3 months with a 3 month recovery period. I was without insurance, sporadic Medicaid coverage, and my neuro had suffered a stroke and was no longer seeing patients so I was without a doctor since he had been the only one in our small town who would take MS patients with medicaid.

I was at the end of my rope and physically/mentally exhausted by the relapses and, looking back now I realize, very close to suicide.

It was by chance that I went to an MS meeting looking for some moral support that I met a neuro from Jacksonville (and hour and a half away) who told us of the trial and the fact that he was the lead investigator. He was very excited because rarely are there trials that lack a placebo. If we were to enter, we were sure to be on some form of medication.

It was all I needed to hear. Within a couple of weeks I was undergoing preliminary testing. I was accepted into the trial and here are my results to date:

I have not had a relapse since April 07.

All of my symptoms have drastically improved.

The only side effects I have had were increased URIs during the first 6 months, and increased UTIs during the first 6 months.

Since the TRANSFORMS study was only a year long comparison study, at the end of 2008 I was invited to join the extension study. During this phase, all patients, even the ones who had been on the real Avonex, would now be placed on the real Fingolimod. The only blind part would be knowing which dose.

The official extension was to last a year but I have since passed that mark and continue on. I am tested/checked every 3 months. Last month I was finally unblinded and told of various results involving my personal experience.

I had been on the real Fingolimod since the first day. I was and still am on the .5mg (low) dose. My MRI has remained stable and unchanged throughout the study. My EDSS score has improved by 2 points bringing me from a 3 to a 1.

I have gone from not being able to walk at all without 2 canes or a walker to not even knowing where my cane is! I can run and jump -- 2 things I thought I would never do again.

I have my life back. I can keep up with my 11 year old son now. I am happier than I have been since being diagnosed (almost 11 years ago now).

There were 8 people involved at my study center. Only 4 chose to be in the extension phase. I found this to be alarming so I asked my trial nurse if she could share the reasons for their choice.

She told me 2 of them were young women who both wished to start families within the next few years, another patient found the long commute to be too much of a bother, and the fourth was moving out of state.

None of them left because they had a negative experience.

I know there is much buzz about Fingolimod and it's potential to come to market this year. I figured maybe I could give a little first hand experience info to people who might be curious.

I know I will really miss it once it gets approved because I have no coverage for medicine and it might be pretty expensive. I only get it for free until the day it hits the market.

I hope this doesn't sound like I'm sugar coating things... there are potentially negative side effects, but I was fortunate not to have experienced any of them -- most likely due to the fact that I have been on the low dose since the majority of adverse events have been seen in the high dose group.

These could include elevated liver enzymes, slight asthma, macular edema, changes in heart rate and blood pressure, increase in upper respiratory infections to name a few. Also, there were 2 deaths from complications involving HSV related viruses (one had contracted chicken pox and the other had viral meningitis).

So there are possible serious complications, but I have not personally experienced any. And you have to remember that there is a big long insert of scary side effects for simple stuff like Tylenol, too. You have to be your own best advocate and weigh the risks/benefits.

The fact that it's a pill is only icing on the cake for me. If it were a shot I would still be just as enthusiastic. It's the results that impress me. :D
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Postby CRHInv » Fri Jan 08, 2010 8:58 am

Tickled - Thanks for sharing your inspiring story. I am soooo happy for you. This will give many hope. I am all about hope! Oh yeah, I LOVE your name!
dx 4/09 * Stanford appointment 11/09/09 * One stent left, low jugular 11/10/09!<br />One year from treatment, I have my life back.  Placebo schmebo.
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Postby sou » Fri Jan 08, 2010 1:50 pm

Thank you for sharing your story. I am very happy that it has worked so well for you.

Personally, I am against the idea of immune suppression because I consider it a temporary and dangerous solution to a permanent problem. But that is just my (sour) opinion.

I wonder what happened to the other 74, though.

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Postby Summer55 » Fri Jan 08, 2010 5:36 pm

Tickled, such a hope inspiring story!!!

Your post on this thread will be very much appreciated by many people! People come to this website to both learn, and find hope.

Your story was not sugar coated as it was, but it was a positive one!

Thanks for sharing!!!
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