gilenia / fingolimod / FTY720

A board to discuss future MS therapies in early stage (Phase I or II) trials.

gilenia / fingolimod / FTY720

Postby dignan » Thu Jun 10, 2010 6:43 pm

I know, I know, the news has already been posted in a couple of other threads, but I just wanted to highlight one thing that I think is a great idea (I think the FDA panel stole it from me, I'm sure they're all dedicated readers of the thisisms forums)

...panelists questioned whether an even lower dose might be safer while still benefiting patients.

Panelists voted 20-5 that Novartis should be required to study a lower dose of the drug.

"I'm not convinced this is the lowest effective dose," said Dr. Donald Fong of Kaiser Permanente hospital network. "And if it's not the lowest effective does, then why should we accept this as the final answer for the patient?"

In a critical vote, the panel said Novartis could conduct the dose study after the drug reaches the market. A requirement to conduct the study pre-approval could have delayed a launch for years."


for the rest of the article:
http://www.google.com/hostednews/ap/art ... QD9G8K4BO0
User avatar
dignan
Family Elder
 
Posts: 1610
Joined: Wed Aug 11, 2004 3:00 pm

Advertisement

Gilenia lower dose

Postby Smilingface » Fri Jun 11, 2010 6:51 pm

Thanks, this was an article I had not seen. It would make sense just to add a lower dose arm to the ongoing trials. I think there is a possibility I am on the placebo, so I would like to see a re-randomization where I would either get .5mg or the lower dose. Sounds more ethical to me!
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 3:00 pm
Location: North Carolina

Postby dignan » Sat Jun 12, 2010 10:35 am

Sounds like a good idea to me. That would get an answer a lot faster since the existing trials have already recruited all of their participants.
User avatar
dignan
Family Elder
 
Posts: 1610
Joined: Wed Aug 11, 2004 3:00 pm

Gilenia

Postby Smilingface » Sat Jun 12, 2010 11:48 am

Hi Dignan,

Actually, the trial I'm in is currently recruiting. I know my study center is trying to come up with 10 participants who qualify. It's the only site in NC and in a large city so I have been a little surprised how long its taking to fill the slots.

Am I correct that there is still an extension study going on with RRMS and FTY720 with .5mg vs 1.25? Or is everyone to date getting .5mg?
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 3:00 pm
Location: North Carolina

Gilenia

Postby Shayk » Sun Jun 13, 2010 4:26 pm

Hollie from the Acclerated Cure Project posted the link to the info presented to the FDA on Gilenia.

An interesting read--I only took a glimpse but think I'll take a definite pass.

FDA info on FTY 720 (Gilenia)

It's almost 400 pages so takes a while to download.

Sharon
User avatar
Shayk
Family Elder
 
Posts: 768
Joined: Fri Feb 06, 2004 4:00 pm

Postby dignan » Sun Jun 13, 2010 4:39 pm

Sharon, thanks for the link, I'll have to check it out.

On the ongoing RRMS studies (I guess they are extension studies), I THINK participants are all now getting 0.5mg. From what I can see in clinicaltrials.gov, that's how it looks.
User avatar
dignan
Family Elder
 
Posts: 1610
Joined: Wed Aug 11, 2004 3:00 pm

Postby SCGirl » Mon Jun 28, 2010 1:04 pm

Smilingface -
I am in SC, not far from NC - can you give me some information on the trial? Are they still looking for patients?
Thanks!
User avatar
SCGirl
Family Member
 
Posts: 52
Joined: Mon Jan 25, 2010 4:00 pm

FTY720/fingolimod/Gilenia PPMS Study

Postby Smilingface » Mon Jun 28, 2010 6:30 pm

Hi ScGirl!

The study I'm in is at the CMC/MS Research Center, part of the Carolinas Healthcare System in Charlotte. The contact person is Rita
Rouse at 704-446-1902. I'm pretty sure they are currently enrolling with a plan of having 10-12 patients.
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 3:00 pm
Location: North Carolina

Postby SCGirl » Tue Jun 29, 2010 4:47 am

Thank you so much Smilingface! That's actually funny.. that's where my neuro is and I have never heard of this study. But that's par for the course for me.. Thanks again! And not sure if you are a college baseball fan, but the South Carolina Gamecocks are playing in the College World Series, you should check it out!
User avatar
SCGirl
Family Member
 
Posts: 52
Joined: Mon Jan 25, 2010 4:00 pm

Gilenya

Postby Bewitched » Thu Nov 04, 2010 11:37 am

Has anyone started on this yet? My neurologist at the MS Center is really trying to push this on me.
User avatar
Bewitched
Family Member
 
Posts: 29
Joined: Mon Aug 18, 2008 3:00 pm
Location: Little Egg Harbor

Fingolimod

Postby Smilingface » Thu Nov 04, 2010 6:00 pm

Hi Bewitched,

I started taking fingolimod seven months ago. I feel better than I have in years. So far the only negative side effect I have had is a drop in my lung function. (That's why I know I'm not on the placebo) I have had some annoying side effects -- mild headache, runny nose, mild nausea.

I think my progression has leveled. I'm hoping for signs of repair and re-myelination but nothing to date.

Fortunately, since I'm in the trial I don't have to figure out how to pay for it!
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 3:00 pm
Location: North Carolina

Blessings to you

Postby Bewitched » Thu Nov 04, 2010 8:08 pm

God, I hope you do O.K. on this. I am so uncertain. I have fears about the side effects and I have a career that I can't afford to lose. I need to be functional at all times. Also, I am a smoker. I'm afraid my lungs will collapse on this stuff.

Thanks so much for replying. I needed to hear from someone who is actually on this stuff. And, are you sure this is not placebo? When is this trial going to end?
User avatar
Bewitched
Family Member
 
Posts: 29
Joined: Mon Aug 18, 2008 3:00 pm
Location: Little Egg Harbor

Fingolimod 0r placebo?

Postby Smilingface » Fri Nov 05, 2010 6:38 pm

For the first 3 months of the trial I wasn't sure at all, although I had the mild side effects of headache, nausea and runny nose. But then stuff started happening --- the energy gain, the call from the neuro that said I had to go in for extra pulmonary function testing because my lung function dropped 20% below baseline, my cholesterol level shot up, then leveled by itself (presumably because my liver was over worked) and I had a UTI (Last one I had was 18 years ago). Yes, I'm as sure as I can be that I'm on the drug. This trial ends December 2013.

I'm comfortable with the side effects because I know I am being monitored carefully. Except for going to the study visits, I have not missed a day of work for a year.

Good luck in your decision! There's a public forum on facebook for those trying to decide whether or not to go for gilenya. You might find it helpful.
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 3:00 pm
Location: North Carolina

Postby Sawdoggie » Fri Nov 12, 2010 11:45 am

I guess this is a question for the mods, but should Gilenia have it's own forum folder with the others as it is now an approved treatment?
User avatar
Sawdoggie
Family Member
 
Posts: 63
Joined: Mon Sep 07, 2009 3:00 pm
Location: Cincinnati, OH

Fingolomod with it's own folder?

Postby Smilingface » Mon Nov 15, 2010 6:17 pm

Mods, that would be great. How do we do it?
Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />
User avatar
Smilingface
Family Elder
 
Posts: 113
Joined: Thu Apr 05, 2007 3:00 pm
Location: North Carolina

Next

Return to Drug Pipeline

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users