Pink, be careful mixing steroids with Ty. My neuro is under the impression that steroids increase your chances of getting PML while on Ty. I have heard different from other sources, but she heads up the studies being done at the main college here and that was one of them.

And yes, it is true steroids have not been proven to do anything as far as stopping the attack. They simply cut down the inflammation that usually takes place around the active lesions, giving some relief to the symptoms. For some reason, I don't seem to have inflammation with mine so the steroids do nothing but make me sick.

JC-virus antibody assay trials underway
 

From Biogen yesterday at an investor conference

The first of the STRATIFY trials, to validate the JC-virus antibody assay, is now underway. The second trial is about to enrol its first patient.

Just a few things:

#1: Pink, as long as you had the blood tests/MRI etc, your doc appears to be sure it is a relapse, and if it is a relapse, steroids are allowed. It sounds as if they are right on top of what needs to be done as far as tests prior to steroids. I hope they help.

One thing I don't understand is that when I had steroids IV during relapses, I always had the three day course. At NO time did anyone ever prescribe 5 days. Why is the protocol/dose different for everyone?


#2: Avonex is now more expensive than Tysabri. Do you think they are pulling a Cephalon move? Cephalon increased the price of Provigil to try to force people onto Nuvigil, since provigil is going off patent. If they can get people on Nuvigil, they retain the $$. Biogen owns Avonex and owns part of Tysabri. Avonex is going off patent soon and any pharma with biological production capability can start making Avonex. Where do you suppose Biogen wants their patients on Avonex to go?

#3: The assay- The FDA is already in trouble for what's been going on with pills and meds-think Avandia. They are going to be VERY careful before approving anything. Ask yourself why they would require a two year trial of a simple blood test. I understand they may need to find where "statistical significance" is, and that the neurologists will get the results, but do they actually think that any good doctor is not going to disclose results to their patient? The patient will be cautioned about trials and stat sig, but the result will be there, negative or positive.
Speak with your neuro if you want this test. You can find more info on the two trials at:

Stratify 1: http://www.clinicaltrials.gov/ct2/sh...d+assay&rank=1


Stratify 2: http://www.clinicaltrials.gov/ct2/sh...s_ex=Y&rank=41

Everything going well here, hope it's the same for you all!

Biogen extended the Avonex patent out to 2026 so it doesn't have to do with patent extension - just greed. Sad that drug price cost has nothing to do with efficacy/relative efficacy.

The 1000 patient trial is a prospective study to prospectively determine the accuracy of the assay (blood test) relative to JC virus present in urine (PCR testing). They should be able to determine accuracy/market the assay after the initial tests of the 1000 patients. The 2 year timeframe may relate to determining the percentage of patients who go from negative to positive over the two year period.

The 8000 patient trial is being run to show the risk of PML for those who test negative on the assay. Given that you can't develop PML without the JC Virus, logic would say that the risk of PML for those who test negative is negligible but you can't put that in the label without clinical proof.

Can you explain how they can determine the accuracy of the assay after testing 1,000 people? Don't you have to follow the people you test to see if those who test positive for JC virus get PML? Urine, blood, and spinal fluid may not show evidence of JC virus but it could be there, right? That's why we need the assay?

The 1000 patient trial is to determine the accuracy of whether someone is JC Virus antibody positive or not - the blood test JC Virus Antibody assay result will be compared to the JC Virus PCR Test Result from the same patients urine to detemine proper correlation - should be positive or negative on both - otherwise false positive or false negative.

The 800 patient study will determine the rate of PML in patients who test negative for the JC Virus Antibody.

The premise of the JC Virus Antibody Assay is that if you've been exposed to the JC Virus you'll have JC Virus Antibodies in your system. 11 of 11 patients who developed PML and had earlier blood samples stored tested positive for JC Virus Antibodies.

I got another call yesterday. They are doing a "satellite feed" and from what I was told it will be country wide and it's radio stations and television stations doing interviews, so I guess the local "Mulch Pile" paper won't be involved. Both my neurologist and I will be interviewed.

When I know more I'll let you know! Has anyone else been contacted for this?

My husband did his "google alert" for TY and PML. There have now been 42 cases. The last 2 were in the USA. I can't find any other info.

This information is from the Dow Jones Newswire (today).

The total number of patients who died of PML is now 9.

Of the 42 cases so far, 15 have been in the US, 24 have been in the European Union, and 3 have been in other areas.

SURPASS

Biogen and Elan enroll first patient in large well controlled study comparing Tysabri to Copaxone and Betaseron in head to head studies.

http://eon.businesswire.com/portal/s...88&newsLang=en