FTY720
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CureOrBust
- Family Elder
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- Joined: Wed Jul 27, 2005 2:00 pm
- Location: Sydney, Australia
Carole-
CureOrBust
- Family Elder
- Posts: 3374
- Joined: Wed Jul 27, 2005 2:00 pm
- Location: Sydney, Australia
assuming all things equall (ie they let the rif-raf mix with the actual drug group of patients...) If 1 in 3 are getting a placebo, the chance of you both getting placebo, using probability, is 1 in 9. Now they are odds I think most people would gamble a fair bit of money on in a casino. So it would stand to reason that chances are that it doesnt have side effects on most people.
I'm in!!!!
Hi!
I have successfully entered the FTY720 phase III trial here in Amsterdam - The Netherlands.
3 day's ago I received my first dose. I had to stay 6 hours for observation.
I've created a blog where I will write any thing I feel extra
or changes in my MS symptoms. Read all about it here.
So far I'm really pleased wit this oral drug.
Greetz,
J.
I have successfully entered the FTY720 phase III trial here in Amsterdam - The Netherlands.
3 day's ago I received my first dose. I had to stay 6 hours for observation.
I've created a blog where I will write any thing I feel extra
or changes in my MS symptoms. Read all about it here.So far I'm really pleased wit this oral drug.
Greetz,
J.
I'm positive that I have the real stuff since I do have some side effects described in the trial papers. So far they are quite easy to handle.carolew wrote:Great LeoDav, I think I am on placebo because the pill is so easy to take and I am still deteriorating sloooowwwwwly. Hope you are on the real thing. Carole
I've read your reports and I do have to agree with you that you might have a placebo
. However it can also be the case you did experience some side effect but never noticed it. Not all persons are alike.My sore windpipe/bronchi's are fading away and today is day 4 so... If the guy in the MScentre had not asked, during the first dose, if I felt any 'pain in the chest' I would have discarded it. And it seems to quickly fade away.
I'm going to get a blood pressure meter as well to follow my changes in blood pressure since that seems to be affected due to FTY720. And for the rest I don't feel a thing.
The only thing you can watch as well is your weight. I've read remarks from other FTY720 trialers that they seem to gain weight (2kg for example). According to their MS nurse it is common for FTY720... So I'm, closely monitoring that too.
J.
Hi all,
My neuro's office is going to be in this trial, but they aren't recruiting yet. I'm thinking this one might be a possibility for me? Although I'm also still considering Avonex and Tysabri. I might be changing jobs in the future and don't know if I'll be able to dedicate a lot of time to going to the doctor on the weekdays. Decisions, decisions...
I also have high blood pressure. Sheesh, so many things to consider.
Carole and Leo,
I hope you both have the real thing and get good results.
My neuro's office is going to be in this trial, but they aren't recruiting yet. I'm thinking this one might be a possibility for me? Although I'm also still considering Avonex and Tysabri. I might be changing jobs in the future and don't know if I'll be able to dedicate a lot of time to going to the doctor on the weekdays. Decisions, decisions...
I also have high blood pressure. Sheesh, so many things to consider.
Carole and Leo,
I hope you both have the real thing and get good results.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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TonyJegs
- Family Member
- Posts: 90
- Joined: Sat Mar 17, 2007 3:00 pm
- Location: Illinios (+ Europe)
- Contact:
Fingolimod (FTY720)
Background Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis.
Methods We randomly assigned 281 patients to receive oral fingolimod, at a dose of 1.25 mg or 5.0 mg, or a placebo once daily, and we followed these patients for 6 months with magnetic resonance imaging (MRI) and clinical evaluations (core study, months 0 to 6). The primary end point was the total number of gadolinium-enhanced lesions recorded on T1-weighted MRI at monthly intervals for 6 months. In an extension study in which the investigators and patients remained unaware of the dose assignments (months 7 to 12), patients who received placebo underwent randomization again to one of the fingolimod doses.
Results A total of 255 patients completed the core study. The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P<0.001) and 5.0 mg of fingolimod (3 lesions, P=0.006) than with placebo (5 lesions).
The annualized relapse rate was 0.77 in the placebo group, as compared with 0.35 in the group given 1.25 mg of fingolimod (P=0.009) and 0.36 in the group given 5.0 mg of fingolimod (P=0.01).
For the 227 patients who completed the extension study, the number of gadolinium-enhanced lesions and relapse rates remained low in the groups that received continuous fingolimod, and both measures decreased in patients who switched from placebo to fingolimod.
Adverse events included nasopharyngitis, dyspnea, headache, diarrhea, and nausea. Clinically asymptomatic elevations of alanine aminotransferase levels were more frequent with fingolimod (10 to 12%, vs. 1% in the placebo group).
One case of the posterior reversible encephalopathy syndrome occurred in the 5.0-mg group. Fingolimod was also associated with an initial reduction in the heart rate and a modest decrease in the forced expiratory volume in 1 second.
Conclusions In this proof-of-concept study, fingolimod reduced the number of lesions detected on MRI and clinical disease activity in patients with multiple sclerosis. Evaluation in larger, longer-term studies is warranted.
Fingolimod (FTY720)
Mechanism of Action, Potential Clues:
Sphingosine-1-Phosphate (S1P) blocks egress from lymph nodes rather than enhancing migration to them.
Effects on migration: Prevents lymphocyte egress. Tightens endothelial junctions. Direct effects on lymphocytes.
S1P Preferential depletion of naïve T cells. Adoptively transferred in vitro activated, polarized T cells do not deplete with Fingolimod.
Red Flags:
- New therapy agent based on old autoimmunity of MS.
- In 1 year period the evaluation of numbers of new lesions and relapses must be considered as not accurate as it shows, means- it proves nothing. Natural Course of MS must be evaluated separately first, and only than you form the group. More, the impressive numbers were shown after 6 months, it is too short.
- There is no information provided on lesions numbers in all groups before trial, so this extrimely valuable information missed.
- We don't know what kind of MS was taken; age of patients, time from onset, etc are also unknown.
-I case of encephalopathy in less than 200 patients (group1 and 2) and in in a period less than 6 months?
Kind regards,
Tony
Methods We randomly assigned 281 patients to receive oral fingolimod, at a dose of 1.25 mg or 5.0 mg, or a placebo once daily, and we followed these patients for 6 months with magnetic resonance imaging (MRI) and clinical evaluations (core study, months 0 to 6). The primary end point was the total number of gadolinium-enhanced lesions recorded on T1-weighted MRI at monthly intervals for 6 months. In an extension study in which the investigators and patients remained unaware of the dose assignments (months 7 to 12), patients who received placebo underwent randomization again to one of the fingolimod doses.
Results A total of 255 patients completed the core study. The median total number of gadolinium-enhanced lesions on MRI was lower with 1.25 mg of fingolimod (1 lesion, P<0.001) and 5.0 mg of fingolimod (3 lesions, P=0.006) than with placebo (5 lesions).
The annualized relapse rate was 0.77 in the placebo group, as compared with 0.35 in the group given 1.25 mg of fingolimod (P=0.009) and 0.36 in the group given 5.0 mg of fingolimod (P=0.01).
For the 227 patients who completed the extension study, the number of gadolinium-enhanced lesions and relapse rates remained low in the groups that received continuous fingolimod, and both measures decreased in patients who switched from placebo to fingolimod.
Adverse events included nasopharyngitis, dyspnea, headache, diarrhea, and nausea. Clinically asymptomatic elevations of alanine aminotransferase levels were more frequent with fingolimod (10 to 12%, vs. 1% in the placebo group).
One case of the posterior reversible encephalopathy syndrome occurred in the 5.0-mg group. Fingolimod was also associated with an initial reduction in the heart rate and a modest decrease in the forced expiratory volume in 1 second.
Conclusions In this proof-of-concept study, fingolimod reduced the number of lesions detected on MRI and clinical disease activity in patients with multiple sclerosis. Evaluation in larger, longer-term studies is warranted.
Fingolimod (FTY720)
Mechanism of Action, Potential Clues:
Sphingosine-1-Phosphate (S1P) blocks egress from lymph nodes rather than enhancing migration to them.
Effects on migration: Prevents lymphocyte egress. Tightens endothelial junctions. Direct effects on lymphocytes.
S1P Preferential depletion of naïve T cells. Adoptively transferred in vitro activated, polarized T cells do not deplete with Fingolimod.
Red Flags:
- New therapy agent based on old autoimmunity of MS.
- In 1 year period the evaluation of numbers of new lesions and relapses must be considered as not accurate as it shows, means- it proves nothing. Natural Course of MS must be evaluated separately first, and only than you form the group. More, the impressive numbers were shown after 6 months, it is too short.
- There is no information provided on lesions numbers in all groups before trial, so this extrimely valuable information missed.
- We don't know what kind of MS was taken; age of patients, time from onset, etc are also unknown.
-I case of encephalopathy in less than 200 patients (group1 and 2) and in in a period less than 6 months?
Kind regards,
Tony
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TonyJegs
- Family Member
- Posts: 90
- Joined: Sat Mar 17, 2007 3:00 pm
- Location: Illinios (+ Europe)
- Contact:
Hi Bob,Lyon wrote:Hi Tony,
I'm having a hard time discerning what you've copied and pasted from an article and your comments. Your only comments start with the words "Red Flags"?
Thanks,
Bob
Try use this link <shortened url>
or hit any search engine with this topic.
Sorry for inconvenience.
One more Red Flag for you as a bonus
.- Instead of continue the follow-up after 6 months and get results after one year, they cancel control group and put them on the drug, and this group started show the reducement of lesions during next six months. (?)
What I would like to say here - it is not clean study, mean - they made it up to achieve certain conlusion. Unfortunatelly it happens pretty often. Big Pharma guys know the drill
Kind regards,
Tony