My Tovaxin Experience so far

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby IHaveMS-com » Sat May 26, 2007 7:32 pm

The neuro in the Michigan leg mentioned that she trained under Dr Kurtzke at Georgetown and he said he remembers her so there isn't much doubt that she's capable of an accurate assessment.


Kurtzke is the one who created the scale. I am not a fan of the EDSS scale, but it is what everyone uses. EDSS assessments are not very consistent from one neuro to another. The key point is that the same neuro gave your wife the change in EDSS. I assume that she is the one who will assess her next time. I will stay tuned.

All of my EDSS assessments have been made by Dr. Loftus. It is more important that the same neuro does the assessment every time than what EDSS score you are given.
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
User avatar
IHaveMS-com
Family Elder
 
Posts: 213
Joined: Tue Jun 07, 2005 3:00 pm

Advertisement

Postby Lyon » Sat May 26, 2007 7:38 pm

IHaveMS-com wrote: It is more important that the same neuro does the assessment every time than what EDSS score you are given.
Absolutely and that's why I pointed out that the same neuro gave my wife her second EDSS and also this last one.

Then again, the first neuro only assessed her half a point different than the current neuro, which I thought was pretty impressive when considering the amount of subjectivity involved..

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby akaheather » Sat May 26, 2007 7:39 pm

Bob-

Congratulations! That is wonderful news. Thank you so much for sharing that with us. I am so excited to hear that people are starting to see positive results. I hope we start to hear more!

My MS seems to be on a similar path as your wife's. So far, no one has been able to tell when I'm having an exacerbation. (Thank God.)

Since my diagnosis almost 3 years ago I've had 3 attacks, but seem to be in remission now. It's hard for me to tell if the tovaxin is working, or if I'm just in remission. The proof for me will be in the MRI's. You can't blame placebo effect on positve MRI results.

Good luck to all!

Heather
User avatar
akaheather
Family Elder
 
Posts: 100
Joined: Wed Mar 07, 2007 4:00 pm

Postby Lyon » Sat May 26, 2007 7:48 pm

Hi Heather, good to hear from you!
akaheather wrote:You can't blame placebo effect on positve MRI results.
That's kind of what Tim was hinting but I'm wondering how certain that is? I mean, if placebo effect can reduce outward symptoms, how could it NOT affect EDSS?
Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby akaheather » Sat May 26, 2007 8:19 pm

My EDSS has pretty much always been low, but I don't think it is something I could necessarily influence, placebo effect or not, unless I was trying to botch it. I know I'm a huge nerd, but I always try to do my best. While someone experiencing a placeob effect might have a "spring in their step", I'm not sure how that would effect things like reflexes and balance? Can that be unintentionaly faked?

I guess anythings possilbe.

Either way, a lower EDSS is GREAT news. Placebo effect or not, enjoy it!!!!!

Heather
User avatar
akaheather
Family Elder
 
Posts: 100
Joined: Wed Mar 07, 2007 4:00 pm

Postby Lyon » Sat May 26, 2007 8:27 pm

akaheather wrote: I'm not sure how that would effect things like reflexes and balance? Can that be unintentionaly faked?
I don't think so....at least the things my wife didn't do well in the EDSS were things she wasn't even aware of and don't seem like the things that she'd have any control of, consciously or not.

Thanks for writing Heather and I'll keep you updated!
Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby IHaveMS-com » Sat May 26, 2007 8:53 pm

Then again, the first neuro only assessed her half a point different than the current neuro, which I thought was pretty impressive when considering the amount of subjectivity involved..


I think those are some pretty similar assessments, but a half point could make the difference of qualifying for a study or not.
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
User avatar
IHaveMS-com
Family Elder
 
Posts: 213
Joined: Tue Jun 07, 2005 3:00 pm

Postby Loobie » Sun May 27, 2007 6:37 am

I'm like Tim, I don't much care for the EDSS. As Bob pointed out, it is very subjective. Like the part where they use the colored object and say "tell me when you can tell it's red" (or whatever color). If I'm a little hot, it takes longer to tell, if I've been waiting for an hour in the cool room, I can pick it up right away. Same guy, same eyes, very different outcomes.

I'm also like Heather in that I always try and "do well" on the walk and the other stuff. I don't think it's nerdy at all. It really helps make sure that you are also keeping it as objective as possible. There have been times when I do the longer walk and I want to slow down, but if I always try my hardest, then the results will be less skewed.

I have always felt that until you really start to show significant disability, it is like using a sledghammer to put up trim. It is so good to be hearing some positive trial results. As I have said about a million times already, I can't wait for the extension!
User avatar
Loobie
Family Elder
 
Posts: 2196
Joined: Mon Sep 11, 2006 3:00 pm
Location: Dayton, Ohio USA

Postby Lyon » Sun May 27, 2007 9:06 am

Loobie wrote:As Bob pointed out, it is very subjective. Like the part where they use the colored object and say "tell me when you can tell it's red" (or whatever color). If I'm a little hot, it takes longer to tell, if I've been waiting for an hour in the cool room, I can pick it up right away. Same guy, same eyes, very different outcomes.
Hi Lew,
Good point, between the subjectivity on the part of the examiner AND the part of the person being examined, EDSS assessment, at best, is just a rough guide.

For the most part I think it's generally accepted as the rough guide that it is and I think it's generally understood that it's not perfect and is only the best we can do right now. On the other hand, as Tim pointed out, sometimes EDSS might be taken too literally and half a point difference either way can keep you out of a study.

Loobie wrote:I'm also like Heather in that I always try and "do well" on the walk and the other stuff.
I think an accurate EDSS is to the benefit of the patient and doing your absolute best is the only control a patient has in reducing subjectivity.

At some point in the future I imagine researchers will implant electodes into the axons of MS patients and run the wires to an external guage which could be hidden above the hairline of the patient. That will be handy because at that point we can brush a few hairs out of the way and say "Lew's got good conductivity today, he's my golfing partner" or conversely
"Mikey, you be Lew's partner today!" :lol:

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby IHaveMS-com » Sun May 27, 2007 9:58 am

I think an accurate EDSS is to the benefit of the patient and doing your absolute best is the only control a patient has in reducing subjectivity.


I always try my best at each of the tasks that I am asked to do. Because we travel 1,100 miles and sleep in a hotel, how well I slept the night before will effect my EDSS. It has bounced around by a half point mainly do to the eye exam.

If my sleep was lousy, the bed was bad, and my appointment was early, I will have to push myself to make the 500 yards. Normally, 500 yards is no problem. If I were to fall short of the 500 yards, my EDSS would jump up, but I would know that the increase was the result of external forces and not an increase in symptoms or disability.

If you feel you did not perform a task as well as you feel you are able to, you can ask to do it again. I had Dr. Loftus walk me twice one time, because the first time I wasn't concentrating and bounced off of the wall a couple of times. The second time I stayed in the middle of the hall.

I think everyone wants to know if there is any improvement, and the only way that the patient can help make the EDSS assessment consistent and as accurate as possible is to do their best.
At some point in the future I imagine researchers will implant electodes into the axons of MS patients and run the wires to an external guage which could be hidden above the hairline of the patient.


Well Captain Bob, get Scottie on the horn and see if he can get some more power out of the old girl so that you can get to this futuristic golf outing.
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
User avatar
IHaveMS-com
Family Elder
 
Posts: 213
Joined: Tue Jun 07, 2005 3:00 pm

Postby Lyon » Sun May 27, 2007 10:12 am

IHaveMS-com wrote:Well Captain Bob, get Scottie on the horn and see if he can get some more power out of the old girl so that you can get to this futuristic golf outing.
Well, this was supposed to be a birthday surprise for Lew, but I've contacted his neuro and the next time he goes in for service he is going to have rabbit ears installed and he will be given a remote control so that he can adjust his axonal conductivity remotely Image

Lew, you and I had talked earlier about the difficulties in determining if someone is on the "real thing" or not and now what you were pointing out is really hitting home.

It's really hard to keep your objectivity when you're personally involved and you don't have enough information to work on. I'd like to think that my wife is on the real thing. At this point it seems sensible to think that she might be on the real thing but I'm not absolutely sure what the placebo effect is capable of and of course, I don't have direct knowledge that she is on the real thing.

For my wife and I to get too excited right now might be setting ourselves up for a real dissapointment later, but to go out on a limb I'd have to agree that you have something to look forward to when this phase of the trial is over and you go on the real thing for sure.

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby Loobie » Mon May 28, 2007 6:07 am

Since I have now passed the halfway mark in the study, Tim pointed out one very beneficial thing to calm the nerves. If you feel like you are progressing a bit, sit down and analyze what your choices really are. You can get one dose of steroids during the trial (or that's what my Doc. said anyway). This could temporarily knock down some inflamation. However, if you become scared about "flying naked" just realize how long it takes the interferons and even Copaxone to really get in your system and start working. Apparently that time period is about six months.

So, for me anyway, I can deal with the wait knowing that if I tank a bit I can get steroids. But knowing that six months is it for me, I'm going to wait on the Tovaxin, not go back on something I could barely tolerate (the interferons, I never tried Copaxone). My Dr. told me he is hesitant to even use steroids unless I really fall off. He thinks that while steroids have a beneficial immediate effect that long term they can actually speed progression.
User avatar
Loobie
Family Elder
 
Posts: 2196
Joined: Mon Sep 11, 2006 3:00 pm
Location: Dayton, Ohio USA

Postby IHaveMS-com » Mon May 28, 2007 8:04 am

Hi Lew,

I think steroids fall into the category of "my patient is having an attack and I want to do something for him/her". If you have used them before, your own track record should be the deciding factor.

If you are in the study, the time you should seriously consider steroids is when you are have a bout of optic neuritis. I don't remember where I read it, but steroids seem to have a more noticeable benefit with optic neuritis. I don't know how you can rehab vision, so I would do what I could to protect it.

I know you have your eyes on the prize (Tovaxin), but I hope you don't set the bar too high. I don't think you will ever know if you were on Tovaxin or placebo. You know my broken-record statement, "the hope for Tovaxin is that it will stop the attacks, any disease reversal is up to your body and future science"

This is from an earlier response to one of Bob's posts, but relevant here. -- It would be illogical to assume that when you stop any disease that the body wouldn't immediately start repairing itself. A paper that I read last week reported that after analyzing data of MS brain autopsies, the researchers were surprised to see how much remyelination had taken place. It was significantly more than was theorized.

In another paper from 6 months ago there was a discussion on at what point in life does the body start to lose it ability to remyelinate. The consensus was that the oligodendrocytes, which are the main repair mechanism for myelin, are active well into middle age. It is logical to assume that someone in their mid-twenties would bounce back quicker than someone in their mid-fifties (I realize your wife is 47), but the mechanism for repairing MS damage is active throughout middle age. I am not sure what is the range for middle age, but the standard for old age is usually around 70.
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
User avatar
IHaveMS-com
Family Elder
 
Posts: 213
Joined: Tue Jun 07, 2005 3:00 pm

Postby Lyon » Mon May 28, 2007 9:39 am

Loobie wrote:Since I have now passed the halfway mark in the study, Tim pointed out one very beneficial thing to calm the nerves. If you feel like you are progressing a bit, sit down and analyze what your choices really are. You can get one dose of steroids during the trial (or that's what my Doc. said anyway). This could temporarily knock down some inflamation. However, if you become scared about "flying naked" just realize how long it takes the interferons and even Copaxone to really get in your system and start working. Apparently that time period is about six months.
Hi Lew,
It sounds like you and I have read the same things, except in the case of my wife and I, that information seemed to make the 1/3 chance of "flying naked" for a year a little easier to accept.

What I read was that it takes 6-8 months for the crabs to reach it's questionable 30% effacicy and that a lot of good researchers question whether use of steroids during relapse actually lessens disability and instead only ends the relapse quicker.

In that light it seems that even if you chose not to enter the Tovaxin trial and instead continued to utilize the best that medical science currently has to offer......that might not really be a far cry from flying naked but instead only gives the false impression of control over disease progression.

The only way to get on Tovaxin in the upcoming years is going to require the year of possibly flying naked. In that regard it's to your benefit that you've taken the leap and regardless of whether you are on the real thing or placebo, the clock continues ticking and the year continues to get shorter.

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby Lars » Mon May 28, 2007 5:25 pm

Hey Bob,
I haven't checked for a while, good news hearing about your wife. I hope she continues to slide down that scale. I have to ask a question which Tim hit on, is it just me or are there others out there that could be completely different on the scale literally from one day to the next? I seem to have days that I almost need a walker and a mule team to get to my appointment and other days that I must be a 1 or less on "the scale". I haven't really had that much of a difference on my clinical trial days but am absolutely capable of vastly varying physical conditions. I have to wonder if the scale takes into consideration peaks and valleys over a period of time. I have never really asked anyone anything about the scale.
Thanks,
Lars
Lars
Family Elder
 
Posts: 433
Joined: Wed Mar 21, 2007 4:00 pm
Location: Durango, Co

PreviousNext

Return to Tcelna (Tovaxin)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users