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Hi Lew,

I am not sure I have read all of your Tovaxin experience posts, but from the ones that I have read, it sounds like you are doing well. I am collecting questions about MRTCs from other sites and putting together some answers. There are many questions that do not currently have an answer.

I just returned from Houston on Tuesday. I have just started my next series of injections in the extension study. It is a series of 5 injections at 8-week intervals, and then make more vaccine at week 52.

I have seen several sites that are wondering what has happened to me. My brothers have not posted anything on my site since last May, but they did say, "We probably will not be doing much updating of Tim’s progress. You can be sure that if there is any significant change, good or bad, we will post that."

The brother that does all of the web work had 3 vertebra fused in January and does not feel like sitting at the computer doing web updates for me. I would like to get a few things up to alleviate any concerns about how I am doing.

I am sure it is an agonizing decision as to whether or not to be in a clinical trial, especially one that has a placebo component. I did not have to make that decision. My father found Dr. Zhang and felt his T-cell vaccine had the best probability of success. I am sure if I said I didn't want to be in the study, he would have been okay with that.

I have read some comments that being in my study would have a positive placebo effect knowing that you were getting the vaccine. The problem with those comments is that at that time, Zhang's vaccine had only reduced the attacks by 40%. Cohen's work had not been published and they didn't have the 100 peptides that they now have for making the vaccine.

I do not check posting on a regular basis, but you know I am not hard to get a hold of. There are enough people posting about their Tovaxin experience, so that I can read instead of write, and my experience has become old news.

How is it that they can modify the vaccine as they go on with the study? How do they know that there won't be dose related side effects for example? wouldn't they be using a different vaccine than the one that was determined to be safe in the last phase?
NN

sh8un wrote:How is it that they can modify the vaccine as they go on with the study? How do they know that there won't be dose related side effects for example? wouldn't they be using a different vaccine than the one that was determined to be safe in the last phase?
NN

Good questions sh8un, I've wondered the same things. One of the earlier phases was intended to specifically address the dosing questions and they found that

The treatment appears to be safe and well tolerated with minimal adverse events and no dose-limiting toxicities.

I think it's important to remember that this is a treatment and not a drug. With a drug if you make it more and more powerful, previous dosing safety determinations are no longer valid.
Because Tovaxin "treatment" relies on removing myelin reactive T cells, increasing it's scope and ability to remove mrtc's makes Tovaxin more effective but no closer to a non-existant toxicity curve, unlike the situation with drugs.

Maybe a better way of putting it is that in the past Tovaxin has seemed to show safe and effective by removing a large portion of the mrtc's. Evidently it's been determined that there is no reason to think that it wouldn't be just as safe and more effective to remove ALL of the mrtc's from circulation. The improvements Opexa is making only go farther towards removing all of the mrtc's and not closer to an unsafe condition. A legitimate safety question might involve over suppression of the immune system but it seems that removing all of the mrtc's doesn't constitute a suppression problem.

TIM, the additional information is appreciated and I'm glad you enjoy the ability to read about the experiences of others in the IIb trial. I have to admit that it is nice to hear from you occasionally as someone who has been on Tovaxin since November 2003 (I checked your website).

If you have Word or Netscape 7.2 and have time and want to modify your old webpage or create a new one, I'll help you put it online when you are ready. When I was first starting that seemed to be the daunting part. Or maybe your brother would be willing to help you transfer it.

I use "smartftp" which is free to individuals and makes adding webpages to your webspace as simple as finding out where to ftp the file and dragging and dropping the webpage file.

Bob

How is it that they can modify the vaccine as they go on with the study?

The vaccine will be modified for the specific individual. With the increased number of peptides used to make the vaccine, there are additional MRTCs being found.

How do they know that there won't be dose related side effects for example?

There appears to be no safety issues with the vaccine. There appears to be no upper bound to the amount of vaccine that can be given.

wouldn't they be using a different vaccine than the one that was determined to be safe in the last phase?

What was determined in the safety phase of the trials was the amount of attenuated MRTCs that would be the proper dose. The dose was determined to be approximately 40 million cells. Since the vaccine is autologous, every vaccine is unique and patient specific. After every series of vaccine, the patient's blood is reexamined and new vaccine is made. The new vaccine may be different than the previous vaccine.

Hi to All,

I ran across this information and felt it was worth passing on. I gave up caffeine several years ago. I was not a coffee drinker, but Mountain Dew has lots of caffeine.

Avoid Caffeine
Research suggests that caffeine may be bad for MS. Researchers found that caffeine can block the adenosine receptor and thus lower the effectiveness of adenosine for suppressing inflammation.

The adenosine molecule is a key player in regulating the immune system by halting inflammatory reactions. Dr Sitkovovsky, the trial leader, said it would be wise for people with MS to drink less coffee.

Source: Nature, 20th December 2001

Now that the Tovaxin IIb trial is underway and we are hearing from an increasing number of participants, it seems some people are convinced that it might be possible to discern if you are on the real treatment or placebo due to site reactions.

Everything I've ever read and anyone I've ever communicated with has said that there is absolutely no reason to consider that you might be able to discern whether or not you are on the real treatment by site reaction.

Of course there is going to be a mark, they stuck a needle in you. If they weren't delicate there might be a bruise, but that has nothing to do with whether or not you got the real treatment.

Additionally, a few days ago I mentioned that my wife was convinced that she is on placebo because in the days after her first treatment her feet were still tingling and it's still difficult to pronounce words.

First, even if she is on the real treatment, Tovaxin can only end the disease process and reversal of symptoms is up to the person's system and won't be immediate...if at all.

Second, I didn't realize that she had called her trial coordinator and mentioned that she's convinced she's on placebo. The coordinator assured her that because Tovaxin is a vaccine it takes a while to work and that the mrtc level doesn't reduce to zero until around the third dose and that even then all you could expect is for the disease to quit advancing. Basically there is no reason to think that at any point that anyone would "feel" any different due to treatment.

It seems that what Heather mentioned is correct, what researchers are looking for is longer term MRI's proving that the disease hasn't advanced.

Bob

That is my take as well. Tim pretty much cleared up the injection site thing by showing that he had a band aid reaction. I think we should heed that advice since being in the phase I, he was absolutely getting the drug. To expound on Bob's thinking (if I may be so bold Bob ) I think we need to remember that this is in no way, shape or form symptom treatment so how would we feel any different?

Wow! I can't believe that you guys have figured out in a few weeks what it has taken many a lifetime to get... I'm usually right.

At any rate, I go in for my 5th injection this week. There is no MRI scheduled with this one. (I thought there was going to be one. ) I guess they are not expecting to really see anything at this point? I really wish we had a more clear cut schedule. I'll try to find out when they are scheduling my next MRI. Wish me luck!!!

Heather

akaheather wrote:Wow! I can't believe that you guys have figured out in a few weeks what it has taken many a lifetime to get... I'm usually right.

Most of us guys are married and learned long ago that it's easier on everyone to cast the truth aside and admit that the female species is always right

In your first post you mentioned that you were going into a relapse. How are things going with that?

akaheather wrote:Wish me luck!!!

As always, I wish you the best of luck Heather!
Bob

Hi All,
Logically, I agree with the views discussed on the last few posts. Medically, how do we explain Tims remarkable symptom reversal?
Good luck Heather!
Lars

Hi Lars,

I don’t think that the people at Opexa can explain why I had a significant disease reversal. I have never asked anyone about my decrease in EDSS. I was pleased; they were pleased.

I think human nature is to question when something bad happens, and not to question when something good happens. When you are getting treated for something, you expect the bad things to stop (attacks). My expectation (hope) was that I would not get any worse. I had no expectation that I would regain some lost function.

I have said that I have a very aggressive form of MS. I only had a brief remission after my first 2 attacks. After that, each succeeding attack produced more disability. I was steadily climbing the EDSS ladder. Although I am classified as RRMS, it was thought that I might have already transitioned into SPMS.

From when my father first thought there was something wrong to my first treatment of Avonex was about 4 months, record time of diagnosis according to the Chair of neurology at University of Michigan. Within 3 years of diagnosis, I was receiving Tovaxin.

Here is my guess as to why my symptoms started improving within the first month. My MS was very active, and the depletion of some of the MRTCs caused by the first treatment of Tovaxin was like going into the remission phase of RRMS. I was in the low dose group and that amount of vaccine did not drop my MRTCs to zero, but it significantly reduced them. This significant reduction would be similar to the waxing and waning of MRTCs in someone with early RRMS.

For me, reducing the MRTCs caused my symptoms to subside. That would be similar to anyone who has had an attack and when the attack is over, they return to a level a little worse than before the attack started, but significantly better than the low point during the attack.

I continued receiving Tovaxin at regular intervals, which I assume kept me in the remission phase. When I was moved into the mid-dose group, my MRTCs did drop to zero. I was not told that, but the study data states that all mid-dose patients had their MRTCs drop to zero.

I have always said results may vary. You can only expect to have results similar to mine, if you have the exact same disease scenario as I have, and I would be surprised if anyone of you had your EDSS go from 0 to 5.5 in 3 years. I know that every unusual feeling makes you wonder if an attack is starting. The hope for Tovaxin is that it will stop the attacks. There is nothing in the vaccine action that would suggest that you will regain lost function.

Many, if not all of you, are looking for some kind of sign, feeling, or reaction. On 4/30/07 I received my 15th treatment of Tovaxin, and I have never had any redness at the injection site caused by a reaction to the vaccine. I have seen many posts where people who are getting into the current study are hoping to see redness at the injection site, and I am concerned that if someone in the study does not see redness at the injection site, they will assume that they are in the placebo group. It should be obvious from my experience that people in the study could see redness caused by a reaction to the Band-Aid or see redness caused by a reaction to the vaccine. The vast majority of patients should not see anything. If you know someone who is in the current study, please point this out to him or her.

I had one false alarm about an injection site reaction. I thought I had an injection site reaction and posted it on my website. It turned out that the redness was caused by a reaction to the Band-Aid. Unfortunately, so many people read that before I went back and corrected the post that it has become imbedded in many people's mind that they must have an injection site reaction or they are in the placebo group. I have never felt anything after receiving an injection, nothing on the day of the injection, nothing on the next day, nothing different at all. If you are expecting to feel different or notice sometime, I am afraid you are going to be disappointed.

It typically takes 3 treatments of Tovaxin to bring the MRTCs down to zero or near zero. Until the number of MRTCs is reduced to near zero, they are still floating around and possibly nibbling at you myelin. It is possible that the memory white blood cells that produce the MRTCs might decide to produce several million and overwhelm the vaccine produced T-cells that eliminating the MRTCs. In that event, you might experience a slight attack, only a guess. The attacks should stop when the MRTCs have dropped to zero.


I have been asked many times why aren’t more people sharing their Tovaxin experience on the web. I think people are more interested in asking questions than telling the world how they are feeling. Here is a blog of someone who is in the study. http://360.yahoo.com/profile-LILKV50ibK ... Ckr49Zl&r=

I have seen a few blogs where there is some information about how they are doing, and then nothing. The pessimist might think that the person had become too disabled to write anymore or had died. I am an optimist. I would like to think that the person is doing much better and is out enjoying him or herself and no longer wanted to sit in front of a computer.

Maybe someone should start a list of websites and blogs of people in the Tovaxin study. I would only include those who have had their first injection. I have seen several blogs by people who wanted to get into the study, but unfortunately did not qualify.

Hi Tim,
Glad to see we haven't lost you somewhere out in cyber-space. Its nice to hear your theory on all this. I think its hard for all the new (including myself) trial folks to get a handle on what to expect. As we've talked about before, my MS road mirrors yours almost exactly and its easy to get swept away with the hope of simillar results. I think the reality is that we all need to show some patience and emotional restraint. Easier said than done. After all, I suppose the word "trial" speaks for itself. I think your idea of collecting information on trial patients is really a great idea. I had toyed with the idea of starting a web site for exactly that reason. The big problem is ........computer illiteracy.
Good to hear from you,
Lars

Thanks for the informational response Tim.

I don’t think that the people at Opexa can explain why I had a significant disease reversal. I have never asked anyone about my decrease in EDSS. I was pleased; they were pleased.

My gut feeling says that the situation involves plasticity.

(brainstorming here..) Plasticity obviously isn't a quick process but can keep up to mask disability for quite a while in someone with disability progressing at the average rate. Once disability is so bad that the plasticity is expended AND the disability is noticeable...improvement of symptoms pretty much is restricted to remyelination.

It seems that in someone with rapidly advancing MS plasticity can not respond quickly enough to mask disability, so as increasing disability is noticed, plasticity hasn't had a chance to do much masking.

Maybe Tim was young enough to have a lot of available plasticity and his MS was advancing quickly enough that when his disease process was stopped his reserve of plasticity went to work to re-route, etc.... and was able to mask the lion's share of the damage and lower his EDSS by a surprising amount..

Notice that almost any startling recovery has been someone young with quickly advancing disease and it seems plasticity is the only logical explanation.

Bob

It's good to hear from you again Tim. I agree with you on the point you make about how people are reacting to the trial. When I first got in I was very enthusaistic about posting 'results'. I think that what you are ultimately saying is there may be no earth shattering results. It may just simmer it down, or it may drop activity to 0. No one really knows yet because it has so many unknowns (guess that's why they call them that ).

I have definitely progressed, but as mine is a case where all symptoms exept my bladder appear when my temp. changes, maybe I'm just flaring up old injury. I have been posting about exercise and relapses and I think I was flaring myself up to the point where I was bringing on a relapse. I, of course, have no way of knowing that, but it really felt like it. I say felt because I have backed way off and I have more energy. I was getting to the point where my legs were getting so rubbery that I was really getting scared about losing my ability to walk.

I can still walk and I still work a pretty mentally and physically demanding job. I am a Eng./Facilites Manager and my physical is only that I probably walk1-3 miles per day. Not exaclty like a carpenter, but I make it OK. I have had extreme difficulty finishing mowing the lawn as of late. I didn't have it last year and I wasn't weak before I started. Thus, I have surmised that I pushed it a bit past my limit and my limits have changed.

I don't feel MS'y most of the time and only get that way when I push it. Yeah, that threshold has changed, but I'm not a laborer so I'm lucky. Once I get to feeling that way I have to stop and take a break. I had really been panicking about reaching that point since it was so new, but it took a behavior change and I think that's hard for us all.

I haven't a clue if I'm getting the drug or not. I go get my "booster" on the 16th of May and I imagine my Dr. will notice my change in EDSS. If he doesn't I'll just have to point it out to him. I've had some incontinence since the last time as well as significant amounts of numbness and tingling. But like I mentioned, it is almost always when I'm over extended for whatever reason.

I have committed myself to finishing the study because I think it's important to my health as well as to all our healths' . Tim is correct in stating how you feel when you are at the low point of an attack vs. your new baseline. I have right at 6 months to go and Im just going to chill out and try and take it easy until then and see what happens when I get into the extension study. If it continues like it has been, then I'll just evaluate at that tiime.

One thing being in this study makes you realize is that you can fall into a trap of becoming too self aware. I have to watch how much "time" I give all of this. It can get consuming and no one, not even healthy people, are any good at that. When you are in a blind trial, unless it's a very "active" medicine, it really is a waiting game.

Hello everyone.

I am in the Tovaxin trial. Actually the link to the blog Tim posted is mine.
I post on a lot of other boards, just haven't posted here. I check these threads daily though so I feel like I already know some of you.

I have my 5th injection at the end of this month and in the begining I just knew I was on the placebo. I felt the same as I always did. I have many symptoms every day and was holding out the hope that I would wake up one day and feel better.
When i didn't notice anything I assumed I was on the placebo.

I am noticing improvements now. This is a very big deal for me since I have had constant activity since 2004.
It was never an overnight thing. It took me almost a month to really tell I was taking a turn for the better.
Of course I could still be in the placebo group and this is just my Ms course.

The constant wondering is really hard. Also focusing on my symptoms trying to notice ANYTHING has been very stressful for me. I am starting to put that aside. Maybe it's easier because I feel better?

I wish everyone the best and will continue to read.