I Have Multiple Sclerosis Forum & Chat Board | News Discussion: Daclizumab Shows Promise in Phase II Trial for MS

Experience Project has found an article relevant to the group:

Daclizumab Shows Promise in Phase II Trial for MS
Just over a year ago, PDL Pharmaceuticals partnered with MS giant Biogen (Avonex, Tysabri) to bring a drug known as daclizumab through trials for MS. Daclizumab is today used for the prevention of kidney transplant rejection, under the marketing name Zenapax (r). The partnership seems to be bearing fruit, as the companies announced that Daclizumab hit its targets in its first Phase II multiple sclerosis trial.

230 relapsing-remitting MS'ers with "active" disease were in the trial. They were broken off into 3 groups: 1 received 1mg of daclizumab per kg of body weight, the next received 2mgs per kg, and the third received no daclizumab. However, it is very important to note that *all* groups did receive interferon-beta treatment. In other words, there was no trial arm that was monotherapy testing daclizumab alone. We will pick this thread up in a moment.

The trial results showed that the 2mg per kg daclizumab group did significantly better in terms of reduced enhancing lesions-- inflammations of the brain generally indicating active disease. Details were not provided, as the full data will be released at a conference later this year.

While positive results in any clinical, double-blind setting are good news for the MS community, the ghost of the Tysabri-Avonex combination trial looms large over this combination. This is probably the last time we will ever witness two immunomodulators/suppressants being administered at the same time, given when Tysabri+Avonex came together, the deadly brain disease PML seemed to be encouraged. What this means is that even if the combination of daclizumab and interferon shows benefit, the FDA would likely never approve it without extensive, tedious but critical safety studies.

The bottomline is that a new trial where daclizumab is trialled by itself will provide the critical insight into whether this will one day be a viable therapy for MS.

Any comments?

 

I assume this is about the Choice Trial- Which I am enrolled in, and I am amongst the annointed 230.   I don't know which - if any dose I was taking - but the Nurse and I both thought I was getting a dose based on my temperature going up afterwards.

The folks at MSLifelines have also been keenly interested in what's been going on with me. I'm kind of a VIP with them right now... but who knows if that will last.

They haven't told me about my many MRIs that were taken during the study either.  Right now I have one more visit to the Hospital for a follow up exam, but the dosing has been over for some time. And for my troubles they gave me whopping twenty bucks per dose.  With the price of gas - it didn't even take care of me driving to the hospital and back.  On the good side, I've become more comfortable with closed MRI and now nap instead of freaking out the whole time I'm in there.

I guess I'd say I'm no worse for wear - but I don't see any improvement either...  This disease Sucks!