Mike's 100 Day Story

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Mike's 100 Day Story

Postby hmtucker » Mon Oct 13, 2008 2:16 pm

Howdy all,

I'm a few days early here but what the heck!

My MS:
I am 42 years old and my first MS attack was in October 2003 and the actual MS diagnosis came during my second attack in August 2004. The majority of my lesions are in my spinal cord so my symptoms are exclusively motor and sensory and manifest as problems with stamina in my legs, overall balance problems, sluggish left hand and tingling in my feet and hands. I have no vision, hearing, cognitive problems or neuropathic pain. I initially went on Betaseron, to which I developed antibodies, and then switched to Copaxone but in spite of these meds I continued to have one to two relatively major flare ups a year. In the year prior to the Tovaxin study I had 2 big flare ups.

Double Blind Placebo Controlled Phase IIb Tovaxin Study:
My original procurement was on December 11, 2006. I went in for my first treatment on March 23 and my last injection was on September 6, 2007. I now know that I was in the Tovaxin arm of the study so I was receiving the actual Tovaxin vaccine.

To summarize the first 8 months of the IIb study, things went very well for me and my MS status. There were many things that had improved significantly during that time frame. My stamina and balance were MUCH better as evidenced by several things. During all of this time my wife, son and I, with the help of my wife’s parents, were in the process of building a new log house and we were doing a lot of the work ourselves. I was able to more than do my share of the work even when it was fairly hard physically like installing the hardwood floors. Yes I would wear out but a good rest would get me going again. Also, due to one of the flare ups the year prior to starting the study my left hand was sluggish and this was pretty evident in the “put the pegs in the hole” part of the EDSS. At the visit for the first injection, the time for the peg test was about 10 seconds slower for my left hand compared to my right hand even though I’m left handed. By the visit for the sixth injection the time for both hands was the same. Although I still had deficits that I was probably stuck with, things were definitely MUCH better for me than at the beginning of the study.

In mid November, about 2.5 months after my last injection, I had a relatively mild thoracic flare that was quieted down with a 5 day treatment with Solumedrol. This flare was relatively more mild than previous flares I had experienced. The flare subsided but I was left with more balance problems and spasticity issues with my legs than before the flare and although my stamina wasn’t much worse I walked fairly close to walls in case I needed keep myself stable. The increased spasticity certainly made things worse because I had difficulty with any type of fluid movement with my legs and that only heightened the balance problems. In the time from the flare to the extension phase of the study things remained pretty much the same with very slow improvements in balance and spasticity in spite of my continued exercise routines. No combination of Zanaflex, diazapan or baclofen could really help to get control of the spasticity. From the time of the flare until the start of the open label extension phase I was only able to complete about half of the long walk part of the EDSS because with the balance and spasticity problems I would end up dragging my toes and tripping myself. I couldn’t continue not because of lack of stamina but because of fear of falling on my face.

On the positive side of things, I decreased from 2 major flares the year prior to Tovaxin to one relatively minor flare during the Tovaxin year. Also, prior to that flare my MS symptoms had improved quite a bit from the beginning of the study. Since I was receiving the actual Tovaxin vaccination, what’s up with the flare? My opinion is that my immune system did an epitope shift with regard to its MRTC profile. In going through some of the published work from Opexa from earlier studies they showed data that about 75% of the people experienced an epitope shift during the year of their Tovaxin vaccination protocol. In a nutshell an epitope shift means is that on day 0 your immune system is making a set of MRTC's that bind to certain parts, or epitopes, of myelin (and the other proteins that they screen against) but by day 365 your immune system has changed and it now makes a set of MRTC's that bind to different epitopes of those proteins. This is at least part of the reason for making a new vaccine each year rather than just giving more injections of the original vaccine. So in my case, it is possible that the Tovaxin vaccine knocked my original set of MRTC's down to zero but my immune system started making a new set of MRTC's that caused my flare. I would love to see the results of my MRTC profile from the blood that they siphoned at each visit. It should be readily apparent whether or not not my MRTC profile had changed from day 0 until the time of my flare up.

Open label Tovaxin Study:
The MRTC test at the end of the IIb phase did indeed come back positive and my procurement for the open label phase was done on May 05, 2008. I received my new vaccination on July 15, 2008 and on October 10, 2008 I received my fourth vaccination.

So how have things gone during these 3 months of the open label phase? The first 6 weeks showed no perceptible differences in the way I felt. Around 6 weeks after the first injection I felt that I could perceive very subtle differences. There were times that after I did something I would think to myself, “hmmm, that wasn’t quite as tough as it was last week.” It was nothing earth shattering but I was starting to feel like MS wasn’t beating me down quite as hard everyday. As the weeks have passed I have seen very slow but steady improvements in my stability and spasticity. I can now manage the spasticity with zanaflex and diazapan and that has dramatically improved my balance and my ability to walk. Again, I’m not going to go run a marathon but I’m able to deal much better with my spasticity. Also, I began to feel that I was seeing improvement with my exercise routines and that I move better both after my workout as well as the next day. In addition, at the visit for my fourth injection on Friday, for the first time in almost a year I was able to complete the long walk part of the EDSS.

So, I am certainly excited with how things are going for me so far in the open label phase. I finally feel that I’m back to the spot that the more that I do the more that I can do. Let’s hope that I don’t go through another epitope shift and that things will continue to move onward and upward!

Take care,
Mike
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Postby Lyon » Mon Oct 13, 2008 3:03 pm

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Postby Loobie » Mon Oct 13, 2008 4:32 pm

Mike,

That is really good to hear that it seems to be working for you. If you ever get the chance, see if you could find out something for me. Yes it's a little bit selfish because I feel somewhat gipped, but at the same time, the percentage you stated about epitope shifts is firmly in the majority of patients. My question is if 75% of patients were experiencing the epitope shift, why was nothing done about it? I actually called down there and they said they weren't able to do that yet and 'epitope adjustments for all' were out a ways.

I guess after I wrote that I answered my own question. This is the discovery phase of this drug, and I wanted something to fix me! Well maybe once they figure out how to handle that en masse. I guess that's how they develop this custom tailored drug. Just sour grapes on my part. If memory serves, there was a brief period where I was feeling better for about 2-3 weeks, but it didn't last and Tim was the one who turned me on to the epitope shift thing. I suppose it's possible that I was coming from a place of if they knew what it was (the epitope shift) then they should check it out and fix it. Maybe they weren't/aren't ready to put that portion of it into production and hopefully they have that solved soon and can start to help everyone they treat since our immune systems seem to be capable of adapting a bit. Oh well, hopefully my set of circumstances is old hat by this time next year and they just have all the proteins covered so your immune system can adapt all it wants and not find anything to bind to!

I'm very happy to hear you are doing well. That's the main thing. I suppose my sour grapes at my tovaxin situation come from me looking for a trial drug, and the related research and development that happens from that period of discovery, to be further along than it was and for them to already have the answers that they have been gaining through this trial. Hang in there. You're more patient than me and I really hope it pays off big time for you.
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Postby CureOrBust » Tue Oct 14, 2008 2:22 am

I keep reading that its failure is because of "epitote shift". Is there any reason that no one is simply saying that there is a major gap in the epitotes that they are specifically looking for?
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Postby Loobie » Tue Oct 14, 2008 4:34 am

In my pea brain, I think it's almost a case of the information getting out before they were ready to let it out. By that I mean that possibly they understand that the epitope shifts are occuring and causing a problem with the overall effectiveness, but they can't do anything about it on a large scale yet. So then you have peope like me clamorring for them to just shift my "juice" when they are still stumbling onto new discoveries about the whole process and aren't ready to start adjusting and re-injecting.
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Postby Lyon » Tue Oct 14, 2008 7:10 am

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Postby Lars » Tue Oct 14, 2008 7:15 am

Mike,
Thanks for the post. I think we all needed to hear a feel good story at this point. Hey, I think I know where you can pick up a phone booth avatar.
Take Care,
Lars
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Postby hmtucker » Tue Oct 14, 2008 9:50 am

CureOrBust wrote:I keep reading that its failure is because of "epitote shift". Is there any reason that no one is simply saying that there is a major gap in the epitotes that they are specifically looking for?


Cure,

The data that Opexa has presented regarding epitope shift was in Figure 3 of a poster (see http://www.opexatherapeutics.com/FOCIST ... 7Final.pdf ). For this assay they were screening the patient's blood over their time course of treatment against the same panel of 100 + epitopes. The data in that figure clearly shows that for 3 of those 4 people, there were significant changes in epitope reactivity. A few MRTCs for specific epitopes remained active throughout the treatment, many went down and for 3 of the people many new epitopes were recognized by new MRTCs at the end of the treatment that were not recognized at the beginning of the treatment indicating an epitope shift. So, the epitope shift idea that we're talking about here has nothing to do with gaps in what they're looking for but for MRTC changes to the same set of epitopes that they're screening for. Now, whether they are screening for ALL of the epitopes that MRTCs react to is a completely different question but one that Opexa has obviously spent a lot of time thinking about.

Take care,
Mike
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Postby Lyon » Tue Oct 14, 2008 10:12 am

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Postby hmtucker » Mon Nov 10, 2008 9:06 am

Howdy all,

I wanted to give a little update on something that has not happened to me since I've had MS! I have now gone a full year without an exacerbation! The longest I've ever gone before was 9 months.

Take care,
Mike
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Postby Lyon » Mon Nov 10, 2008 2:20 pm

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Postby CureOrBust » Mon Nov 10, 2008 5:37 pm

Lyon wrote:......not only lack of exacerbations but lack of disability progression.
Unless bob knows something in particular, I think the last statement should be a question.

Have you had no progression? any improvement in EDSS?
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Postby Lyon » Mon Nov 10, 2008 5:43 pm

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Postby Lars » Mon Nov 10, 2008 8:13 pm

Thanks Mike,
I agree with Bob, your ability to put issues into words is remarkable. I can barely remember what I felt like last week. Kudos. I did however decide that MS and non functioning body parts was pissing me off and spent 3-4 days hunting Elk and hiked 3 or 4 miles a day (with a backpack). I'm an idiot and have incurred the wrath of the MS Gods. I guess I would rather die trying............
In the words of a Shawshank legend; get busy living or.........
Peace,
Lars
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Postby hmtucker » Tue Nov 11, 2008 11:09 am

CureOrBust wrote:Have you had no progression? any improvement in EDSS?


Howdy all,

First, I thank you for all of your nice comments on my writing ability. Describing technical issues I guess is a product of my profession. However, don't expect much if you want me to write a fluffy story!

As for my progression status, things have at the least been very stable with slow improvements (although sometimes they seem pretty subtle). As I describe in my previous 100 day story post, I still feel that I'm in the situation where the more I do the more I can do. As for EDSS, I have not asked the score throughout this whole process. However, after my November flare I was not able to complete the long walk. At each subsequent visit I was able to make it closer to completion but it wasn't until my fourth injection visit of the extension study phase that I was able to complete the long walk. The EDSS score is pretty heavily weighted on mobility so I'm sure that it has dropped significantly since the November flare.

Take care,
Mike
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