FTY720 Trial for PPMS took an interesting turn today

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FTY720 Trial for PPMS took an interesting turn today

Postby Smilingface » Fri May 15, 2009 6:27 pm

May 20th was the date I was scheduled to enter the FTY 720 trial for PPMS patients with an intensive day of screening tests. I was trying not to be too hopeful about it because it is 1.25 mg vs placebo. (50-50 chance). I had arranged my ride, scheduled the time off work and started worrying about my lymphocytes level getting too low.

Today, I get a call from my study coordinator who says something intriguing has just happened.

I am told now I have a choice between the original 1.25 mg vs. placebo trial or another trial with 50% chance of .5mg, 25% chance of 1.25 mg and 25% chance of placebo. This trial will not get started til fall.

Guess what I decided to do after 2 minutes of thinking on it.

Wonder why all of a sudden there's a new trial? It's got to be a positive sign about FTY 720 recent data, don't you think?
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 />
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Postby Lyon » Fri May 15, 2009 7:42 pm

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Last edited by Lyon on Wed Jun 22, 2011 2:44 pm, edited 1 time in total.
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Postby Smilingface » Sat May 16, 2009 6:13 am

I had been given the paper work for the 1.25mg vs placebo trial but had not signed it. My understanding is that the original trial continues as is with most of the already enrolled participants in Canada.

The original trial answers the question: Is FTY720 effective in PPMS?
The new trial answers the question: What dose?

I am hoping that means Novartis has new recent evidence that FTY 720 is going to work on PPMS and that's why there is a new trial with a new question.

I do tend to be optimistic .....But try to be realistic :)
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 />
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Postby dignan » Sat May 16, 2009 10:27 am

That new trial does sound better. I think you're more up to date on fingolimod research than I am, but the results presented a couple of weeks ago at the AAN meeting suggest why the 0.5mg dose might be better I think (the article linked below is very thorough and better than a typical press release):

"This trial met its primary end point and demonstrated superiority of fingolimod, both groups, over interferon beta1-a," Jeffrey Cohen, MD, from the Mellen Center at the Cleveland Clinic Foundation, in Ohio, told attendees here. "The relapse rate was reduced by 52% in the 0.5-mg group and 38% in the 1.23-mg group, and both groups showed reduced [magnetic resonance imaging] MRI lesion activity."

In general, the drug was well tolerated, with a safety profile similar to what has already been seen in other fingolimod studies, he noted. The lower dose appeared to be better tolerated than the higher dose and may be more effective.

http://www.medscape.com/viewarticle/702487
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