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Two articles on FTY720.

Novartis Pharmaceuticals initiates new world-wide Phase III study for Fingolimod (FTY720)

Following a two-year phase II clinical study, in which Novartis Pharmaceuticals reported a relapse rate reduction of more then 50%, compared to placebo, with 77% of people taking Fingolimod (FTY720) remaining relapse-free over two years. Novartis has announced the initiation of a world-wide Phase III study in more than 3000 people with MS.
The FREEDOMS multi-centre study, is to evaluate the effectiveness and safety of two different doses of Fingolimod(FTY720), compared to placebo over 24 months. It will be recruiting people between the age of 18 and 55 with relapsing-remitting MS that must have experienced 1 relapse in the last year or 2 relapses in the last 2 years.

For details on which UK centres will be actively recruiting for this study please go to http://www.clinicaltrials.gov/ct/show/NCT00289978


Researchers Uncover A Novel Mechanism Of Action Of A Potential New Drug For The Treatment Of Multiple Sclerosis

Virginia Commonwealth University researchers have identified a unique mechanism of action of a new drug that shows great promise for the treatment of multiple sclerosis.

The researchers report the unique action of FTY720, or Fingolimod, an immunosuppressant drug that was already known to affect the functioning of the immune system by preventing the egress of white blood cells from the lymph nodes into the blood. The article was pre-published as a First Edition Paper in Blood, The Journal of the American Society of Hematology, which appeared online on Sept. 28.

In this study, the research team observed that FTY720 also inhibited the activity of a key enzyme called cPLA2, which is necessary for the production of inflammatory mediators, known as eicosanoids. Eicosanoids drive inflammatory disorders such as asthma and multiple sclerosis.

According to Sarah Spiegel, Ph.D., professor and chair in the VCU Department of Biochemistry, and lead author on the study, the inhibition of cPLA2 would shut down the entire inflammatory pathway, possibly without the side-effects caused by medications such as Vioxx, that have been withdrawn from the pharmaceutical market.

FTY720, a drug developed by Novartis, has shown considerable therapeutic effects in a recent small, placebo-controlled clinical trial involving patients with relapsing-remitting multiple sclerosis. The study was published in the September 2006 issue of the New England Journal of Medicine by an international research team.

"With its novel mode of action and the added benefit of an oral formulation, further clinical development of FTY720 might have a major impact on treatment of MS".

"By clearly understanding the mechanism of action of drugs such as FTY720, we can develop more optimal treatments for inflammatory disease such as asthma or MS. This drug may prevent both inflammation and axonal damage, including demyelination, which are characteristic of MS," said Spiegel.

This work was supported by grants from the National Institutes of Health, and the National Science Foundation.

The research team included Shawn G. Payne, Ph.D., a researcher in the VCU Department of Biochemistry, who made the discovery of the novel actions of this drug; researchers Carole A. Oskeritzian, Ph.D., Rachael Griffiths, Preeti Subramanian, all in the VCU Department of Biochemistry; Suzanne E. Barbour, Ph.D., and Charles E. Chalfant, Ph.D., both professors in the VCU Department of Biochemistry who contributed vital reagents and expertise; and Sheldon Milstien, Ph.D., a neuroscientist with the NIH.

Source: Science Daily Copyright © 1995-2006 ScienceDaily LLC

I not sure i understand the testing of drugs. If you give a person a drug to see if it reduces the amount of relapses but the nature of ms is so unpredictable in the first place how do they know it’s the drug and not just the disease itself. It seems to me that if you hade a pattern of symptoms that happened for sure at a certain time and they stop then you could say it’s the drug. What about the guy who naturally has a series of attacks and then goes for years without any, if this person began this trial at the right time it would seem that this drug is working and would go down on paper as part of the positive results. Is there any of that 77% that is just a coincidence. Someone please set me straight on this... thx

Well, Robbie, I'm probably the last person on the planet to set anybody right about anything but you are absolutely correct for the individual which is why everything is done in crowds (read: trials) and "proven" statistically. Any one person might disprove anything but over thousands (we hope) the truth is revealed.

Lee

Robbie,

Actually I think you hit this on the head. This is what I whine about all the time. Its a legitimate question, with serious implications. A lot more people are being diagnosed with MS than ever before. Is it due to better diagnostic tools (ie. MRI, LP test, and VEP)? Partly, but MRI's don't mean a whole lot when it comes to MS. I wonder if you pulled 1000 random people off the street how many of them would have lesions on their brain, high protien levels in their CSF, or delayed VEP responses? I haven't been able to find a whole lot of data regarding this, and I think its because it may reveal some truths about what we call MS, and the flawed diagnosis protocol.

Now, granted, I ended up in the hospital due to a neurological symptom, but since June '05 (my first and only problem) I haven't had another symptom, and I don't feel like there is anything wrong with me. How many others are there like me? I was taking Rebif, but stopped. If I were in a study, would I not give that study positive test results? If I were in the hospital for my same nerological symptom (nystagmus) 10-20 years ago, what would have been the diagnosis then? Probably not MS, and I may have gone about my life again, and perhaps not had any other problems, or been on any medication. Well in this day and age, I am labeled with "MS". So back to the point. I consider all of the results to any of these new drugs to mean absolutely nothing. Not enough time has passed to prove the effectiveness, and that is really needed to prove that the drug can delay, or stop "MS". If they can release a drug that will give back EDSS points to those who have been truly affected by this disease then you know you have a drug that is truly working for at least that subtype of "MS". The next question is: How many subtypes of "MS" are there, and what are there true causes. MS is obviously a generalized term for any unexplained neurological disorder.

Brock

P.S. Interferon effectiveness results = placebo combined with cases who really may not be "MS".

So there you are...you want real, actionable data that you can "take to the bank." But you know better too. All this kerflufful we go through here on this site keeps us in the mix I guess but there is very little data there and 100 times more than there was just 10 yrs ago. You're on the leading edge...you don't have to like it but you're going in any event.
It's not my idea of a good time to have my fate in so many other hands either.

Lee