TOVAXIN ROLE CALL

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby Lyon » Sun Dec 30, 2007 3:31 pm

Loobie wrote:It was good to see where everyone is at without having to remember where they were.
Hi Lew,
I had to do it because my mind is too scattered to keep track of it all!

Loobie wrote:One thing that I think I'm confused on is exacerbations and pseudo-exacerbations.
It's interesting that you mention it because that very point is why I started that Bromley/Raven thread. Despite the fact that Campath/Tovaxin/Revimmune are very different things, the results of a stopped disease process is the same.

I guess this question formed in my mind a while ago with the consideration that you would eventually like to go back to exercising. There are reasons to believe that overexertion might promote progression while the disease is active, but since it "seems" that people who have stopped the disease process continue to experience ghost symptoms in times of stress, heat, exertion and sickness. Is overexertion going to cause a problem even after the disease process stops? Will it lessen until eventually disappearing or will ghost symptoms be something that past MS sufferers will have to endure for life?

We've heard from Tim, and while there is no doubt that stopping the disease process was a Godsend, he still experiences ghost symptoms on occasion.

I re-read David's webpage and in his November 2007 update, he experiences ghost symptoms. I haven't heard from Robin/raven but it sounds like Ian experiences re visitation of past problems despite stopping the disease process.

Loobie wrote:One thing that I think I'm confused on is exacerbations and pseudo-exacerbations. I have noticed that some people write that tingly legs are a pseudo EX and some write that they are a full on EX. I think I'm splitting hairs here, but if I have tingly legs after every single time I walk over 100 steps or so am I having pseudo EX's?
My guess, and it is just a guess, is that if after the disease process has been stopped and those people experience the same things under heat/stress/sickness/exertion that it's not an exacerbation but involves overtaxing damaged circuitry in both situations. The restricted multi lane highway/optic nerve situation you talked about earlier, only involving brain circuits other than the optic nerve. Remember that the optic nerve and spine are considered extensions of the brain.

Loobie wrote:Am I off base here?
It "seems" you're right on the money...in this case, sadly.

My son and I are going out to eat but there is a ton about this subject which could be written. Again, it's neck deep within the subject of plasticity.

Bob
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Postby Loobie » Sun Dec 30, 2007 7:07 pm

Yeah,

Some of my thoughts parallel yours. The over taxing of damaged circuitry analogy is the type of analogy I can relate to. It's like the damage is already there and you just flare it up with heat and exertion. That's the way I've always thought of it. When you look at my legs, they still (I can't say the same for my abs) look like runner's legs. When people ask me about that I tell them the old potatoe and light bulb analogy. You remember that one from Jr. High? Two copper strips and a light bulb? You could get some light out of it, but it was dim. That's how I explain it. The musles are still there for now, but since the circuitry is damaged, they are there in potential state only. The light bulb has the potential to get brighter....you get the point.

I think that's where some of my "time frustration" has come from as it relates to my recent crazed state trying to get them to take my blood. I can still look in the mirror and see that the potential is still there. I just want to get on with the potential (there's that word again) stoppage so I can try and get some strength back. I sure hope that stuff works!!
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Postby Lyon » Sun Dec 30, 2007 8:01 pm

Loobie wrote:The musles are still there for now, but since the circuitry is damaged, they are there in potential state only. The light bulb has the potential to get brighter....you get the point.
Hi Lew,
I think it might be justified to consider that brain atrophy might play by those same rules. Other than a few roadblocks which have to be detoured around, most of those atrophied areas might just be in the "potential state".

Bob
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Postby flipflopper » Sun Dec 30, 2007 8:36 pm

I have not given an update in a while. Sorry about that. I will do this now.


At the beginning of the month of October, I felt a lot more tired than usual (which is not a good thing since I have record breaking fatigue on a normal day) and I also felt dizzy. I felt the same way I feel during every relapses I had in the past. I also noticed a very small loss of visual acuity in my left eye. I have had many optic neuritis in both eyes in the past and Uthoff's Phenomenon comes on very easily when my body temperature is slightly increased. Therefore, for me, an imperfect vision is pretty much my new "normal". About 2 days after my symptoms started, I had my last vaccine. I informed the trial coordinator of my symptoms but I also mentioned that I was not ready to call it a relapse just yet. My vision was tested and my results were similar to the previous time so they decided to give me my last vaccine.


A few days after my appointment, I started feeling that my right leg and arm were slightly weaker than usual and my right arm felt numb (usually, only my thumb felt numb). A few years ago, I had a relapse affecting my right leg and hand but I recovered pretty well. But suddenly, I felt the same level of increased symptoms in my arm and leg as I do when I take a warm bath (without having to take the warm bath).


The next week, I was still dizzy and more tired than usual. I eliminated the possibility that my increased symptoms was caused by an infection.


A month later, at my next appointment, my EDSS increased from 3.0 to 3.5 and the doctor mention that I lost more points because I wasn't feeling things as well. Like some of you might point out, I know that a .5 difference in the EDSS from one appointment to the next is very small.


It took me a while to classify this as a relapse and it is easier to classify it as a relapse in retrospect. But, because of the increased level of fatigue and the dizziness that stayed with me for 3 months (where I practically didn't leave the house because I didn't feel good enough), I don't have any doubts that this was a relapse. Now, I am just starting to feel the way I did before my relapse. I should point out that I am slow at recovering from my relapses and that for me, taking this much time to feel better is normal. My right hand is still a little numb (it's mild enough that I don't really care about it) but I always take 6 months to fully recover from a relapse so my hand still has time to improve a little more.



I intend to join the extension study but I keep my eyes wide open for a plan B if Tovaxin isn't right for me.
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Postby Lyon » Sun Dec 30, 2007 10:49 pm

Thanks for the update flipflopper.

It's good to hear that you're about recovered but I'm sorry to hear about what you've gone through. I wish I knew more about what counts as an exacerbation. Even though it sounds like you pretty much experienced past symptoms with increased intensity, because it lasted so long I think it counts as an exacerbation.

flipflopper wrote:I intend to join the extension study but I keep my eyes wide open for a plan B if Tovaxin isn't right for me.
Always having a plan B up your sleeve is the intelligent thing to do.

Through history MS has made fools of innumerable intelligent and well intentioned people and their treatments of choice. It's REALLY going to piss me off to find that I'm just one more in a long line of fools. At this point I still don't see any reason to think that's going to happen, but it ain't over until the lady of ample proportions sings.

Early warning, Tim said well in advance (and it makes sense) that mrtc's don't approach zero until somewhere around the third dose in the extension trial.

The long lapse in dosing in the latter part of the first year of the trial means that, not only those who were on placebo, but also those who had been on the real treatment, could experience exacerbations for quite some time into the extension phase of the trial. It doesn't seem that would happen very often, and it "seems" the exacerbations would be mild because, if Tovaxin matches its reputation, the mrtc level would start going down upon the first dose.

My heart's going to drop with everyone else's if I hear about an exacerbation after the extension starts, but it's not beyond the realm of possibility and won't necessarily be indicative that Tovaxin isn't what we thought it was going to be.

Regarding my wife and I? Our plan B is Revimmune, and plan C is spending a month in the poorest area of Mexico we can find, intentionally drinking the water, and chowing down the food. Even though both of the kids are over 14, we'll bring them along.

Bob
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Postby Sweetyhide » Tue Jan 01, 2008 4:04 am

Wow..nice summary Lyon.
Thanks for taking the time to do that.
I know for me it's hard to remember everyone and how they are doing and where they are in the study.

Happy New Year to everyone!
~Sweety
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Postby Lars » Tue Jan 01, 2008 1:47 pm

Dr. Bob, (I think I like the new moniker)
Do we know when the 11b interim study data will be released? Or, has it already? I'm sure this has been addressed in a thread somewhere. I probably wasn't paying attention but I seem somehow more desperate to know than I once was.
Thanks,
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Postby Lyon » Tue Jan 01, 2008 5:29 pm

Thanks Sweety. I'm going to try to keep it updated a little better now than I had in the past.

Lars wrote:Do we know when the 11b interim study data will be released? Or, has it already? I'm sure this has been addressed in a thread somewhere. I probably wasn't paying attention but I seem somehow more desperate to know than I once was.
We had talked about this back in June but I asked Tim's opinion and that information might be released somewhere around the end of the second quarter.

I'm not sure I like the title "Doctor Bob". Brings "Dr Phil" to mind and I think that boy's a little light in the loafers :lol:

Bob
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Postby flipflopper » Tue Jan 01, 2008 9:38 pm

Lars wrote: Do we know when the 11b interim study data will be released? Or, has it already? I'm sure this has been addressed in a thread somewhere. I probably wasn't paying attention but I seem somehow more desperate to know than I once was.

Lars



Lars, I was wondering the same thing!

I'll have to go back to past articles/ press releases I have saved but I am 99.9% sure that Opexa mentioned numerous times that the interim data for (I think) the first 72 patients enrolled in the trial would be published before the end of 2007.

During my last appointment, the trial coordinator told me that the interim results for the trial would be published in December (2007) and that I was included in those first 72 patients.
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Postby Sweetyhide » Wed Jan 02, 2008 4:40 am

Come to think of it, my coordinator told me the same thing Flip.
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Postby patrickm » Thu Jan 03, 2008 8:10 am

Hi All.
Just catching up after being away from here for a while.

It's important for everybody to remember that the subset of people posting on here is very small compared to the number of people in the study, and that this small group could easily skew one way or the other. I think support and information sharing are the important things, but drawing big conclusions based up a small, non-random sample of the entire study would seem to be a big mistake.

That said, understand the desire to do so. We all just want to know what's going on with us as individuals and that there's hope for us as a group. I think Tovaxin's past results show that hope, or none of us would have signed up in the first place.

As for me, I go in on 1/11 for an MRI and exam. Here's my last update I sent out on 12/18:

Got my last shot, my booster, on Friday, 12/14. Did all the normal hoop jumping except MRI. Dr. Wynn wants to keep an eye on my severe fatigue and has increased my dosage of Provigil to 100mg 3x/day to help get me through the day a little easier. Right now the fatigue is my main problem. Other small things lurk occasionally, but the constant exhaustion is definitely the angry elephant in the room.

I have no more shots in this trial. I get MRIs and office visits in Jan, March, & May and then I will go into the open label trial this summer, where everyone will be guaranteed vaccine.


take care and hang in there everybody,
patrick
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Postby Lyon » Thu Jan 03, 2008 6:40 pm

Thanks for checking in Patrick and I'm glad to hear that you are doing well.

I knew I had missed some people in my list. Sorry!
Bob
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Postby patrickm » Mon Jan 07, 2008 9:01 pm

Lyon wrote:Thanks for checking in Patrick and I'm glad to hear that you are doing well.

I knew I had missed some people in my list. Sorry!
Bob


Hey man, no worries. I've posted only once or twice and I don't stand much on ceremony.

Thanks for the good thoughts.

I go for MRI and exam on Friday. Woo.

patrick
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Postby Lyon » Wed Jan 09, 2008 8:07 am

If anyone would like to be removed from this list or wants me to modify their information please let me know and I'll quickly make the change.

Although I may have overlooked other members who have entered the Tovaxin IIb, for the sake of honesty there one who posted regarding entry into the Tovaxin IIb but asked NOT to be included



pvns2005-last post on thisisms Fri Jan 26, 2007 2:41 am but seems to be doing well according to blog http://blog.360.yahoo.com/pvns2005

Lyon's wife-experienced a 2.5 drop in EDSS after 1st shot and before second. Without seeing the mri's it seems to us that she hasn't experienced any progression. She doesn't have any noticeable disability to reverse.

flipflopper-last post on thisisms Fri Dec 07, 2007 1:14 pm
Wed Aug 29, 2007 7:34 pm reported:
flipflopper wrote:I don't have much to report either. I had 4 vaccines so far. My last one will be in October. I still have no improvements or worsening of my symptoms or of my EDSS. I never had any side effects or injection site reactions after my vaccines except for the 4th one where a tiny area at the injection site stayed red for 2 days. Essentially, nothing has changed (which I know can be good if you have ms) and I am still really struggling with my worst symptom; fatigue.


Loobie-has experienced continued progression, has had blood draw to make first vaccine of the extension and at this point should be about 67 days away from it.

Libreni-last post at thisisms Mon Jan 08, 2007 6:23 pm-from what I can tell in other posts it seems that Libreni decided not to enter the IIb and was taking Cal EAP infusions.

merlin26-last post at thisisms Mon May 21, 2007 11:48 pm
merlin26 wrote:I live here in Portland, Oregon where they are currently holding trials of Tovaxin at St. Vincents hospital. I was the very first person to apply for this trial and I have qualified now twice. Yes, thats right, two times. The first time I tested positive for MRTC's and gave a pint of blood it was shipped off using DHL to Texas only to have it be held up by bad weather and thus "grandules" had formed and it was deemed unusable. To deem it unusable the first time around took of course 10 weeks. I was issued an apology and asked if i'd like to try again? I said "sure" and again I tested positive for the MRTC's and again I gave a pint of blood. Fast forward to 10 weeks later. The hospital gets a call from the lead study coordinator of Opexa to tell them that we're very sorry but "A technical error occured during the final processing of my blood". The hospital of course apologized as did Opexa and asked if id like to try once again? Now due to the fact that May is the last month they'll be accepting participants for the trial this will be the last time I will be allowed the opportunity to try to get the vaccine / placebo. At this point i'm extremely frustrated. Six months have already passed and in those 6 months I qualified for the study twice only to have things screwed up by shipping, and then by the lab. It's not fun having to give about 20 vials of blood up front to test for viruses and then having to give a pint each time. The only reason I continue to try is I really do believe in this product. I just hope Opexa gets its act together this time and gets things right. I dont know what the hell a 'technical error' means as they didn't choose to elaborate but I do know that my hope has been with this vaccine ever since I heard about it. I find it rather ironic how I was the first person to apply for the trial here in Oregon and now if the blood ever gets processed properly ill be the last person to receive the vaccine / placebo. Anyways i'm glad to hear about the rest of you who may have received it and are doing well. I hope to one day be right by your side. As of now though I am forced to once again anxiously await the results which won't be in for 10 weeks.


JesusChangedMyLife-last post on thisisms Fri Jun 15, 2007 8:49 pm
JCML wrote:On June 5th I went in for round two of the shots. Still no site reaction although I was very slightly sore at both injection sites, but really very little. I keep looking for somebody in here that is in the Tovaxin study that is doing REALLY well, something like Tim's kind of turn around story. Does anyone know of somebody in this study that is experiencing a great turnaround? It would be great to hear from somebody like that. On a lighter note and a much more positive one, my wife and I are expecting our first bambino (or bambina?) in another 5 months, so we are thanking God for that. I really do have so much to be grateful for but I have yet to be able to add MS to that list. I really hope and pray for you and your family members to see great improvements.


hmtucker-last post on thisisms Tue Dec 18, 2007 10:43 am-Mike seemed to be stable through the db/p phase until he had a "thoractic flare" in the latter part which seems to be resolving.

Lars-last post on thisism Fri Dec 28, 2007 7:46 pm-has experienced disease progression through the db/p phase and like Loobie is counting the days until beginning dosing in the extension phase.

akaheather-last post on thisisms Wed Aug 08, 2007 11:02 pm-this isn't heather's last post but is indicative of her experience in the db/p phase
akaheather wrote:Well, I have been rockin right along without much going on until recently.

When I get out in the heat my legs have been getting tingly. When I get back inside and cool off it goes away. Yesterday, however, I noticed part of my stomach was numb (about the size of a plate to the right of my belly button.). Not MS huggy like to last time this happened, but still noticable.

The tingly legs was definately a psuedo attack, but what about this stomach thing? Could this be old injury from an attack that happened over a year ago, or is this a new attack?

I had my 5th injection in May and my year is up in November. So far this is my 2nd "problem" since being in the tovaxin trial. (I had a very mild case of optic neuritis (possible old injury) in March. )

The good news is that both of these "problems" have been relatively mild, but for all of our sakes, I kind of hope I'm on placebo.


Sweetyhide-last post on thisisms Fri Dec 28, 2007 3:54 pm Says she is doing well and looks forward to the extension.
blog at http://360.yahoo.com/sweetyhide

RS-Girl-last post on thisisms Fri Jun 01, 2007 8:06 pm-nothing in her 4 posts to indicate progression or not during the db/p phase.

ssmme-last post on thisisms Sun Dec 23, 2007 5:21 pm-in past posts Marcia said she is doing well and will be entering the extension phase.

TWG-last post on thisisms Thu Dec 20, 2007 1:14 pm-has experienced progression in the db/p phase but intends to enter the extension.

JanethePain-last post on thisisms Mon Dec 03, 2007 1:23 pm-had a "flare" or exacerbation in June. I don't see that she's absolutely said that she's intending to enter the extension but I get the idea that she will.

patrickm- Not patrickm's last post but quote is indicative of IIb experience as of Sep 16, 2007_
patrickm wrote:Did you get better or worse?

Initially, I'd say I was a little, teensy bit better with my EDSS down on my last visit to 1.0 from 1.5, but by Tim's rules, that's only for 1 visit so it still could be natural variance. I have my 4th injection coming up on Friday 9/21 and for the last 2 weeks, to both me and my wife, I have been noticeably worse with brutal fatigue and cognitive issues.
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Postby JanethePain » Wed Jan 09, 2008 9:27 am

Lyon wrote: JanethePain-last post on thisisms Mon Dec 03, 2007 1:23 pm-had a "flare" or exacerbation in June. I don't see that she's absolutely said that she's intending to enter the extension but I get the idea that she will.


Oh heck, yeah, I'm in for the long haul or until they throw me out for some unforeseen reason(s). :lol: I haven't really felt better since June and right now I have this crazy virus going on--really bad cough but with no fever to indicate flu-y stuff. That made today's scheduled appointment with MRI impossible! The prescription cough syrup kicks that cough but makes my vertigo almost unbearable--so driving right now is out of the question.

So I've gotten delayed on my protocol by a week and am really annoyed with myself over it.

But as sorry for poor little moi (as Miss Piggy would say) as I am, I know the next phase of the study is closer than it was. I am SO ready for that next huge blood draw!
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