TOVAXIN ROLE CALL

[IHaveMS-com]

Hi Marcia,

What does the extension study include?

Your extension will be different from mine.

Will we continue to have the MRI's, timed walks, peg and number tests or will we just come in for injections periodically?

I assume you will have several MRIs per year, but less than you have had during the first year of this study. You will probably have at least 2 neurologist evaluations, but more likely you will get one at every visit.

I have never done a peg test. In fact, I don't know what one is. I do timed walks and some mental stuff, but no number test. I spell a word forward and backwards, list some current events, and remember and repeat some word at the end of the exam. I do get a neurological assessment every time I am at the site. They don't seem to need as much information in succeeding years.

How often has it been necessary for you to provide additional blood for vaccine or are they still making it with your original pint?

I give tubes of blood every time I go to Houston. Sometimes I am asked to ship some blood, but that is now infrequent. I give a new bag of blood at the end of each year, from which, new vaccine is made. To my knowledge, they do not use previous vaccine.

(My apologies if you have expressed this information in another thread or much earlier in this one but I haven't much uninterrupted time to read the older posts. I try to keep up with the new ones at least.)

Whether I have answered these question in the past or not, isn't important. If I can answer a question and possibly eliviate a concern, I am happy to that.

[Lyon]

I plan to continue but just wondered what others in IIb feel about continuing.

Hi Marcia,
My wife has never considered NOT continuing through the extension trial, but like everything else involving MS, everyone's situation and choices are going to be different.

Bob

[Lars]

TWG,
Thanks for the post, the overall body of information is invaluable to all of us. On that note, has anyone else noticed that there are far more posts discussing "no change" or "worsening symptoms" than there are success stories? I must now include myself in the former categories. Maybe the success stories have better things to do. I too am starting to have questions about the extension study although I don't qualify until June. I think the question of joining the extension study would be much easier for everyone (placebo or not) if we were hearing great accounts from the trial class. So, how about a thread from the members with good results that we can easily access and get our daily dose of hope.
Bob, what happened to Darth?
Be Well,
Lars

[ssmme]

My thoughts seem to lean toward Lars' thoughts. I do keep in mind that no change might be the ultimate result for most of us. De-myelinated nerves that have died will probably not miraculously come back to life. But if tovaxin halts the myelin attacks in their tracks then no worse is better than the alternative.

My personal goal is to halt the disease, get into a good exercise routine that will get me running again, and then ultimately run a 1/2 marathon. I hope with the help of tovaxin, I will get there.

Marcia

[Lyon]

later edit: Hi Marcia,
I took so long on my post that I hadn't noticed yours. VERY ASTUTE! This post kind of says what you did, only I'm more wordy, as usual!

Bob, what happened to Darth?

Hi Lars,
The image of kilroy always has given me the impression of curiosity or nosiness, which I can associate with!
Actually, Dom had called me Darth on a different thread, so I found that image, but only wanted to use it temporarily.

It does seem odd that such a seeming high percentage of people who are reporting seem to be finding "no change or worsening symptoms". I'm not trying to sugar coat the situation but there are a lot of factors which might be coming into play and I've had to use to console myself to that situation.

The most obvious and important factor actually involves several related factors.

Unlike Campath and Revimmune results we are seeing, this is a clinical trial in which, more or less, 33% of the people we hear from are going to be on placebo and might or might not be expected to progress. I know that sounds pretty wishy washy, but the GREAT importance of a clinical trial is in analyzing the results of hundreds of people and avoiding situations which utilize a few results, and that's what we have here.

Also, despite it being nearly impossible to distinguish "temporary" from "permanent" damage caused by MS, it's important to keep in mind that MS does ALWAYS cause permanent damage and once damage becomes permanent, it literally becomes a separate issue from MS. Permanent damage is a "gift" that is yours to keep and do with what you will, left behind from an unwelcome house guest.

With that in mind and regardless of whether or not the treatment is Tovaxin, Revimmune or Campath, different people have an infinite variety of disabilities dependent on an infinite mix of temporary and permanent causes and after stopping the disease process, those people are going to notice an infinite variety of improvement or lack of improvement.

We literally are going to see some people hopping out of wheelchairs and others with mild disability noticing no improvement of symptoms and that's where the hope for stem cells and methods of utilizing plasticity come in. Regarding stopping the disease process among the general MS population and not necessarily in the Tovaxin IIb clinical trial.

The point is that although the "no change" mentioned above isn't what we as individuals would like to see, or hoped we'd see from Tovaxin, it's not necessarily a negative factor in that the most that can be expected in any clinical trial, regarding a treatment designed to stop the disease process, is an end to progression. ANY benefit is frosting on the cake.

I know it was mentioned in another thread that the primary endpoint with revimmune is improvement of disability. There is no doubt that they will experience improvement of disability along the way, but that is no more than claiming credit for the body's ability to heal itself after stopping the disease process and involves incomplete understanding or dishonesty on the part of the revimmune people.

Despite that seeming indiscretion, I do have great hopes and great interest in the idea of rebooting the immune system.

Bob

[Lars]

Hey All,
To edit my previous post, I have always been OK with "no change" and never really expected anything more, the problem seems to be that a disproportionate number of people seem convinced that they are on placebo because of worsening symptoms. We can't all be on placebo. I consider "no change" a success and think those patients should also be on the "success" thread. I would start it myself but I don't qualify. I haven't lost faith in Tovaxin but I would love to see the scales of clinical trial justice even out.
Still Hopeful,
Lars

[lyndacarol]

Lyon, you wrote:

it's important to keep in mind that MS does ALWAYS cause permanent damage

I admit that I am usually a Pollyanna and try to look on the bright side. And with today's freezing rain, I am also a bit of a contrarian. I don't want to believe we have permanent damage. Show me the proof of permanence! I think once the cause is known and stopped the body can heal itself and function properly again.

As Lars, I am ever hopeful.
Lynda

[Lyon]

Hi Lars,
I hope it didn't seem that anyone was coming down on you. I didn't get the idea that you were questioning Tovaxin and even if you did, that's within your rights.

I agree that it does "seem" that the disease process hasn't been stopped in a disproportionate number of people we are hearing from, there are a lot of other factors we need to keep in mind when we view the situation on such a small scale.

Wishy washy again on my part I'm afraid to say, but how could we do an honest "success" thread? This trial involves CIS and "early/mild" MS, which means that most anyone in this trial doesn't have a long history to compare "success" against, even when "success" is only considered no further progression.

My wife hasn't experienced progression, but I can't say with complete honesty whether Tovaxin or fate is responsible. I'd imagine that most anyone involved in this trial who aren't experiencing progression necessarily have to view it the same, due to the nature of the disease conditions Opexa sought for this trial.

That pretty much turns it into a situation in which there is no positive side of the tally sheet for Tovaxin, only a negative one.

I never kept a good tally of the total number and names of the people in the trial who have come to this site, although I'd guess around 15 or 20 so we are left to guess if not hearing again from them could be considered positive or negative.

Considering the entire situation, to me it just seems that we don't have the information available to us to even give us a hint one way or the other.

Even if we did have everyone accounted for and their opinions, we would have been dealing with insufficient numbers and lacking the information (mri, etc) available to the researchers.

With it in mind that:

progression of disability certainly signifies failure but the lack of progression doesn't necessarily signify success.

posting the above information on an internet site isn't a controlled situation and doesn't necessarily accurately give an accurate reflection of the true situation.

I do think it would be interesting to start new thread for people to post their experiences on Tovaxin/Placebo so far...with it in mind that by the time that enough people have wandered back through and posted, most people will already be in the extension and have a pretty good idea of what the "real thing" has in store for them

Bob

[Lyon]

I admit that I am usually a Pollyanna and try to look on the bright side. And with today's freezing rain, I am also a bit of a contrarian. I don't want to believe we have permanent damage.

Gosh, this is going to be a hard one to explain Lynda. I've been on record for agreeing with exactly what you're saying, but on the other hand I think it's absolutely valid to say that NO ONE is going to come out of their encounter with MS unscathed and it all revolves around the issue of plasticity.

It really seems that someone has MS for at least many years before they have the slightest awareness. Underlying that, behind the scene, plasticity (the healing process) has been doing it's best to keep everything functioning correctly.

When you experience your first symptom causing you to seek medical help and diagnosis, that isn't the beginning of MS, that's when damage has surpassed the ability of plasticity, either in speed or capacity, to compensate for that damage in that pathway or "circuit" and you notice it.

Remember back in science class when the teacher told you that humans only use (something like) 30% of their brain capacity? I thought, most everyone jumped to the conclusion that there were huge unused areas of the brain.

What it really meant (it seems to me) is that the brain has an inherent safety mechanism, in that it's circuits are overbuilt to compensate for lost function due to aging and damage. Rather than falling on an "unused" part of the brain, a "silent" lesion would be one in which inflammation and subsequent scarring occurred at a rate slow and mild enough that plasticity was able to completely mask.

Keep in mind that I've read researcher estimates anywhere from 4 to 7 "silent" lesions for every 1 that you "notice" negative effects. I can't say that plasticity is absolutely finite, but there must be some limitations to its capacity, so you could say that even "silent" lesions are doing "permanent" damage because they are using the limited resources of plasticity in that circuit to keep you from noticing the damage.

Part of me finds it valid to consider that everyone with MS suffered permanent damage long before they were even diagnosed. Permanent damage doesn't necessarily strictly mean "noticeable" damage but means the irretrievable loss of something you had and an MS diagnosis means that you've already lost plasticity capacity.

On the other hand, what is "permanent" really? Situations change. Damage that is unquestionably permanent today WON'T be permanent when/if stem cell repair becomes an option. The type of plasticity intentionally promoted in stroke victims is almost limitless, but takes a lot of tireless effort. Is damage considered permanent if someone isn't willing to go to the required effort to resolve it?

I'm not really qualified to define the word "permanent" for someone else.

If that didn't mix you up, it sure's hell did me. If someone understands what I just said, please explain it to me!

Bob

[ssmme]

I like to think all of us on Tovaxin will eventually see some improvement if the vaccine works as it has been designed. I think plasticity is possible in everyone but to what degree depends on the damage. Some scarring may resolve itself but some is there permanently. Some people may have a better ability to get rid of scar tissue. I sure hope I'm one of them.

Marcia

[CureOrBust]

I don't want to believe we have permanent damage. Show me the proof of permanence!

I really don't want to believe it either, but I think the proof has to be conclusively the other way, and based on the "here and now" treatments.

The type of plasticity intentionally promoted in stroke victims is almost limitless, but takes a lot of tireless effort.

I would like to see this research. Something based on extensive stroke damage. Another thing to remember is that the type of damage (and location) is different to MS.

[Lyon]

The type of plasticity intentionally promoted in stroke victims is almost limitless, but takes a lot of tireless effort.

I would like to see this research. Something based on extensive stroke damage. Another thing to remember is that the type of damage (and location) is different to MS.

Hi Cure,
I suppose their is research on the subject but I was speaking from personal experience, what I've seen many times. Possibly "almost limitless" was an exaggeration but one instance I'm especially familiar with is my aunt who had a massive stroke about 10 years ago which paralyzed her entire left side. There was no miraculous recovery, she had to work for it, but at this point you could never tell she'd ever had a stroke.

I know the type of damage and locations can be different but I'm not how valid that point is when you consider that brain damage from a car accident can be different from either MS or stroke, and that damage benefits from plasticity.

Bob

[Lyon]

Not anything new but I spent a little time going through past posts and compiled some of the information into one place.
Bob

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:

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

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

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

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.

[Lyon]

Deleted double post.

[Loobie]

Thanks for doing that Bob. It was good to see where everyone is at without having to remember where they were. 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? I don't think anyone can answer that except to say that it's not likely that something that happens numerous times every day could be an EX. I think the way my disease presents itself (look up Uthoff's sign) is just tricky. I go up and down like a yo-yo every single day. The only times I don't are days I am a complete and total couch potatoe, and even then my eyes will go foggy two or three times during the day.

That's the only way I can tell that I'm progressing. Looking for things that are there at rest. I suppose I just answered my own confusion. I don't think tingly legs occasionally is a sign of anything but exertion or heat. My Dr. told me that the reason why everyone is tested for EDSS from a baseline of rest is so that the score isn't skewed if you just walked in off the street after a lot of exertion. Hell, if you look at me in the morning before I start moving around, you would notice nothing except me going to the bathroom frequently. But catch up to me a few hours later, I'll be limping, stumbling about and peering at everything for a long time because I can't make it out through the fog (and still going to the bathroom all the time). I just hope people aren't going and getting steroids when they get tingly legs. I just found out from my friend whose 20 year old daughter has MS, that she did 3 days of steroids and full taper for having L'hermitte's for the first time! I told him to find another doctor for her because if he prescribes steroids for something like that, she won't have any bones left in a few years!

Am I off base here?