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