Extension blood draw rescheduled!

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby patrickm » Tue Jan 08, 2008 6:35 am

ssmme wrote:The first couple of times that I got my injections the vaccine caused a painful feeling in my arms. It basically hurt when the vaccine was going in (NOT when the needle went in), it didn't exactly sting but it hurt.


Sounds to me like they pushed the plunger too fast. Supposed to be slowly injected over 30 seconds according to my trial nurse and supposed to go in at an angle. <shrug>

The temptation to examine the minutae of the study is overwhelming, I admit. Since none of us know anything, then there's a feeling that we've gotta examine everything just in case it gives us some info.

Ahhh, the life of a lab rat, though I prefer gerbil myself. :?
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Postby JanethePain » Wed Jan 09, 2008 9:17 am

patrickm wrote: Sounds to me like they pushed the plunger too fast. Supposed to be slowly injected over 30 seconds according to my trial nurse and supposed to go in at an angle. <shrug>


My trial nurse told me the injection is supposed to be slow so "the cells don't get busted up." (yip, she has an adorable accent). That was fine by me... I just couldn't get over getting shot in the back of the arms (plenty of fat, so I was told...). :lol:

patrickm wrote: The temptation to examine the minutae of the study is overwhelming, I admit. Since none of us know anything, then there's a feeling that we've gotta examine everything just in case it gives us some info.

Well, there's that old control issue, for sure, but I wish the protocol allowed for very active participation--such as providing us a forum like this with all the participants. Actively monitored by an Opexa rep to make sure panic and/or rumor didn't steal the show, it would have given so many more a chance to connect with and support each other.

Oh well, maybe for the next phase. :)

patrickm wrote:Ahhh, the life of a lab rat, though I prefer gerbil myself. :?

Lab rats can be very cute, ya know. :lol:
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Postby patrickm » Wed Jan 09, 2008 9:58 am

JanethePain wrote:Well, there's that old control issue, for sure, but I wish the protocol allowed for very active participation--such as providing us a forum like this with all the participants. Actively monitored by an Opexa rep to make sure panic and/or rumor didn't steal the show, it would have given so many more a chance to connect with and support each other.


That's a very interesting idea. I know through my doctor that everybody in research is squeamish about this sort of info sharing within studies. Like music sharing, the genie is out of the bottle. Obviously, it's very possible to unblind ourselves, each other, and anybody running the study if they happen across this info in a forum or blog, or it is shared with them by a patient. My feeling was that nobody's really sure how they should deal with it and that there aren't any standards set forth in the scientific community. I think that's a good place to start.

Set some boundaries. I'm sure that there will be people who ignore them, as there are with all rules, but for me at least, I WANT the study to succeed. I want to get better and I want this drug to get through without delay so it can help others. A forum moderated by the drug company, with clear rules about what can and can't be discussed, and WHY, would go a long way. Then we could all know what we could and could not share with each other without fear of screwing stuff up, or feeling like we're elementary school kids talking about sex when we really don't know what we're talking about and are sure we'll get in trouble if caught.

I am on another forum for my car, and they have very clear rules about posting things that lead to breaking the law or endangering others. You can't post about how to modify your car to have DVDs play in the front seat, for example. It's dangerous to yourself and others and they could get sued. Posts of that nature are deleted or altered. It's still quite a boisterous place. I think that if these sorts of rules where spelled out, along with the rationale behind them, then more often than not we'd be able to deal with it knowing that we had free reign to talk about everything else.

I see my doc on Friday for an exam so I'll mention this to him.

In other news, I'm also on another very supportive MS site called patientslikeme.com. I recommend it highly. Very unique and informative and they have a good mission. There's ony 2 Tovaxinites there, Lars and me, so come on over!
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Postby ssmme » Wed Jan 09, 2008 10:02 am

I never heard nor read in the procedure checklist that the nurse should inject the serum slowly. None of mine were ever injected that slowly. None were ever done super fast just what I would consider a normal speed. I'm no medical professional and don't know how to describe it. I would guess though that if the cells could get busted up then all the cells injected back in me were busted up. Hmm...I wish I had this discussion back when I was receiving the injections. I could have discussed it with the administering nurse.

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Postby ssmme » Wed Jan 16, 2008 10:52 am

Lars wrote:ssmme,
How are your results?
Lars


I just returned from my 16th visit. I had an MRI first, then went into my test site/neuro clinic. I asked my doctor to tell me how my EDSS has charted out. He said that it got progressively better from 4 down to a 2 then spiked back to a 4 when I had a pseudoexacerbation from a bladder infection and that now it's currently at a 1.5. I asked the unblinded nurse if she knew if I was on placebo or the vaccine and unfortunately she said she didn't know. I knew she wouldn't tell me which I was on but I wanted to know if she knew.
The research coordinator said they haven't received any info regarding the extension study except a letter from Opexa that there would be one. My one year is up March 1st but my final visit isn't until March 13th. They should have more info by then. I emphasized to them that I would like them to get in contact with me when they get the information so I can get things rolling as quickly as possible following or in tandem with my March visit.
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Postby hmtucker » Fri Jan 25, 2008 11:16 am

Lew,

Quick question for you. Did they use the 18 or so vials of blood that they siphoned from you at your last regularly scheduled visit for the IIb trial to do the assay for the presence of MRTC's or did you have to come back in for a separate visit?

Thanks,
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Postby Loobie » Fri Jan 25, 2008 12:43 pm

Mike,

Those were the ones they used and they had a few extra vials to gather also. This was all during the period where I was very disillusionsed about not getting my new vaccine procured right away so my memory was a little sketchy since I was so focused on that, but I didn't have to go back in for a fresh extension visit and blood draw. My coord. said that they want to roll your last extension visit with your first trial visit, and I would imagine that is why. So you should expect to have all the "tube blood" taken at your last visit of your first year.

I was expecting them to draw the bag then and got a little carried away with my attitude about that not happening. As it stands now, my first shots should be Mar. 5th or so, so if all the rest go as I did, the first shots of the extension take place roughly 3 months after your one year anniversary of your first shots.
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Postby hmtucker » Fri Jan 25, 2008 3:09 pm

Thanks Lew,

I wonder as the protocol is tweaked and modified if they will use the tubes of blood from the next to last visit for the next stage MRTC assay and then the big bag-o-blood procurement a week or so after that. That would mean that the next vaccination would be ready very close to the end of the one year time period.

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Postby Loobie » Sat Jan 26, 2008 7:34 am

For everyone's sake, I hope so. However, I know that not everyone took a 3 point EDSS dive during the trial either. If my MS had behaved like it had prior to last year, I would have thought nothing of the delays. I mean in the grand scheme of things, 90 days isn't much, but when you are slipping and you think there could even be a modicum of a chance to get some of it back, it becomes very time sensitive to you. I have no idea if these delays will/have cost me anything. It's all past now and I have about a month to go, so I'm just trying to stay calm until that time. I think the trial just hit me at the wrong time, basically right at the same time my disease decided to really show up. Hopefully I'll get some recovery over the next year and halt it in it's tracks. I just realized that I have not exerted myself enough to barely crack a sweat in about 9 months. I had to lift a heavy guage yesterday to demonstrate something, and I actually thought I was getting a fever. It was just from the exertion of lifting something a bit too heavy. That is my big landmark. Even if Tovaxin acts just like it should for me, I don't really have any illusions of getting back to a solid hour workout every day. However, if I can at least get back to where I can exercise or work in the yard enough to break a sweat and feel like I'm contributing to my wellness, then I'll be tickled pink.

How did you do in the cold weather this week? It made me stiffen up like crazy when I had to be outside; damn it was cold in Ohio this week. I used to want the cold to give my eyes some relief. Now I want to live where it's 65 degrees all year round! Does anyone know if such a place exists? I'd move there tomorrow!
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Postby Lyon » Sat Jan 26, 2008 7:34 pm

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Postby hmtucker » Sun Jan 27, 2008 6:16 am

Loobie wrote:For everyone's sake, I hope so. However, I know that not everyone took a 3 point EDSS dive during the trial either.


Agreed. It's just that in a placebo style study, there are going to be more than a few folks where an extra couple of months may be a big deal! Then you need to throw in the idea of epitope shifts even for those folks who are receiving the actual vaccine. I hope that they consider these kind of things as they move into the phase III studies.

Loobie wrote:How did you do in the cold weather this week? It made me stiffen up like crazy when I had to be outside


Yep when its as cold as it was last week my legs feel like they are an 8X8 post! Since this little flare that I had back in early November overall stiffness/spasticity has been something that I've had difficulty getting control of. In the mornings things are really stiff but as the day moves on and I move around things loosen up somewhat. At the last Tovaxin study visit (the next to last before the end of my year on March 20) the doc and I talked about it and we made the switch from baclofen to zanaflex. We'll see how that goes as I find the dose that suits me the best.

Loobie wrote:Now I want to live where it's 65 degrees all year round! Does anyone know if such a place exists?


I think about the closest that you could get is San Diego! It's a dry 72° ± 3° there all year long. Bob's suggestion of Mammoth Caves may be a little too cool as it's 54° year round down in the big hole!

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Postby Lyon » Sun Jan 27, 2008 9:31 am

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Postby Loobie » Sun Jan 27, 2008 10:16 am

I, too, absolutely love Kentucky. Many of us Ohioans make the trek many times a year to Lake Cumberland or to Daniel Boone forest. Some of my fondest memories of adolesence are backpacking trips at Red River Gorge and Daniel Boone state park. Our best friends own a little house/bungalow down on the Cumberland river, and we have had many, many mad parties down there on the water. Hey, it's the closest that us flatlanders get to mountains.

I have been to San Diego one time and temp. wise you are right, it's as close as you can get to ideal. I think it's one of the most appealing places in the country to live, but so do many others, which is why I can't afford to live there!

I actually exercised yesterday. I think it may be the N-Acetylglucosamine, but my dizziness seems to have taken a bit of a break and my hamstrings felt more stable so..... I ran about a 1/2 a mile. When I say run, I need to explain. Any self respecting walker would have passed me. I was taking strides that were probably no longer than my walking strides, but I was chugging it out, running stride and all, and I managed to sweat! It could have been the ski attire I had on since it was 22 degrees out, but I don't care. I sweat! Yesterday was groundbreaking for me this year. I have tried on numerous occasions to run and have not made it three houses before my legs were literally so wobbly that I could not continue. After I wrote that post about not sweating, I got up and told my wife I was going to try and jog. Today I am so sore I feel like I ran the NYC marathon yesterday. It feels so good. I was crying for about half of the distance. I kid you not, it was that significant to me. I felt like ass for about 4 hours, but I have been soooo sedintary. I think I needed to take a big enough break to where that distance seems like I was doing something.

By that I mean I was really bummed as my distances started to decline over the last few years. Running was so much more than just exercise to me. It also kept me regular without having to do anything to help me go, and made me feel mentally and spiritually strong. I mean running everyday is supposed to build your endurance. Now that I've taken such a big break because I literally could not do it, that 1/2 mile felt like a real accomplishment rather than a real loss in ability. I guess it comes down to how you look at things and from which side you look at the problem. I'm so damn happy about doing that I may go for some sit ups today!

I hope this is not just a good few days I'm having. However, since I have had such a big break from exercising, I don't think it will be nearly as devastating to me if I have to back way off again. After all, the first time we face a loss is the hardest. Tim said it would be beneficial to do some light exercise before the first injection, and hopefully I can start now and still be exercising by early March when my shots are due in.
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Postby Lyon » Sun Jan 27, 2008 5:02 pm

Loobie wrote:Any self respecting walker would have passed me. I was taking strides that were probably no longer than my walking strides, but I was chugging it out, running stride and all, and I managed to sweat!

Obviously stopping the MS disease process is such a new development that there are no experts in this field.

I'd like to think that, after the disease process has been stopped, if someone can only move a finger, they should move the living hell out of that finger. If someone can only run slow, they should run slowly as far and long as they can.

On the other hand, it seems that the people who have already stopped the disease process still deal (decreasingly) with fatigue, being bothered by heat and experience worsening of symptoms due to exercise and other factors. It would be nice to know the mechanisms behind this, but at this point we can only guess.

Personally, I think it's almost obviously due to the limited capacity and conductivity of specific damaged neural networks which heat and other factors decrease conductivity even farther and existing damage becomes more noticeable.

After the MS process has been stopped, the big question involving exercise is, will "pushing through" only generate short term amplification of symptoms or is it really somehow serving to increase disability, despite the fact that the ongoing disease process is no longer a factor?

I imagine studies will be done after it's commonly accepted that the disease process is actually being stopped with some of these treatments, but that doesn't do you much good at this point in time Lew me bucko.

Bob
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Postby Sweetyhide » Mon Jan 28, 2008 1:19 pm

Speaking of rescheduled appts.
My first appt. for the rollover was just rescheduled.
Instead of tomorrow I have to wait another week.
Coordinator said something about paperwork delay.
HELLO!!! Ever heard of a fax?!? geez

Still hanging in though.
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