Loobie's second shot update

[pi-hole1]

The extension study is unblinded and patients will continue getting Tovaxin until FDA approval.

Hi there. Delurking because I was wondering about this. How much do you think the patients who want to stay on Tovaxin will have to pay? Also, do you think Opexa will have some sort of price reduction for study subjects who can't afford it until insurance covers it?

TIA everyone. This is a great site and I'm glad I found it. I learn something new here every day.

[Guest]

That is a very good question. I have been told that I have access to the drug if I've been on the placebo, but I didn't think about whether or not I have to pay for it. I don't believe so since they have to "spin it up" whether you are getting it or not to keep it all blind and I don't imagine they would just pitch it out instead of giving it to you.

The other thing to note is that the way they are trying to do this drug (vaccine), you don't have to 'stay on it'. Their hope is that after the 3 or 4 initial shots and a couple of boosters, it won't be a regular therapy like the CRABs.

Hopefully Tim reads this and expounds on it a bit, but I think I have the facts straight, but I plan to ask that at my next injection.

I just got my third dose and after the next one I don't go back for 3 months. I've been feeling pretty stable but have seen no reversal of symptoms. However, the drug is only designed to stop progression, so I think if there is to be any symptom reversal, it will have to be your own body initiating it since it does not have any "remyelation stuff" in it. Basically my hope is that if it stops it, it will allow my body to do some repair work.

Lew

[Loobie]

That's me in the post above, I wasn't logged in!

Lew

[Lyon]

Thanks for the update Chris.

What you mentioned is all new to me, my wife had the blood taken yesterday to have the Tovaxin made from (procurement?) so she hasn't been dosed yet.

It sounds like they're going to do an EDSS every time you have an injection?
Bob

[Loobie]

Lyon,

I have had to to an EDSS each time. I've done two MRI's out of three injections, but the EDSS is every time and there are lots of questionnaires that have to be filled out as well about fatigue, depression, quality of life, bladder and bowel issues, etc. Those may be part of the EDSS as well, but I have to fill those out and take a peg test and a PASAT test each time.

The PASAT is a cognitive test where they read you two numbers and you give the sum, then you hear the third and add it to the second factor in the equation and so on until you have answered 60 of them.

The whole thing takes about an hour and then you get dosed and have to wait an hour to be observed.

Lew

[Lyon]

The PASAT is a cognitive test where they read you two numbers and you give the sum, then you hear the third and add it to the second factor in the equation and so on until you have answered 60 of them.
Lew

Thanks Lew,
I can see this is going to be very frustrating! I drive my wife there and sit with her because it's about an hour drive each way. They had her do that PASAT test at her last appointment.

When she's doing these mental tests, I can't help but also run them through my head. I also have a tendency to get pissed off when I don't do things well. When I walked out of there I was so mad I could have strangled someone. In 52 years I don't think I've ever been more frustrated.

Is there actually someone who could do well on that darned PASAT test or was Einstein the last of them? They also do some darned test where they tell you three words and talk to you about five minutes and ask you what the words were. Next time I'm going to tell them to shut the hell up until the five minute are over because their talking is very distractive. One of the words was "deer", I did remember that much.

My wife, the one with MS, seems to do pretty well on the tests.

Bob

[Loobie]

Yes, those tests can be frustrating. I got 60 out of 60 on my last one and since it was a Friday and only trial patients were there, the research coordinators both took it and never got 60 (I'm seriously patting myself on the back here). I was feeling like a pretty smart feller'! I just have to close my eyes and bow my head and really focus. It's not the easiest thing to do. They say it's a short term memory thing as well, but when they say short term, do they really include 5 seconds in that category?

Some of the stuff they test for seems so foolish, but they way they presented it to me was that this trial was targeting low EDSS'ers to see if early use of Tovaxin could halt the progression entirely. I know this because I actually asked why I was a good candidate when I was still so functional except for my vision and my Dr. explained it that way.

Even though I don't love the mag., the last InsideMS from the NMSS has an article about how hard it is to try and get drugs through that deal with symptoms that arent' objectively identifiable through means like the EDSS. If you ask me, early symptoms are almost immeasurable with the EDSS. It's a very, very rough indicator until there is some significant disability. The thing they need to focus on, if you want my $0.02 is a scale for the symptoms that aren't readily available to be objectively measured.

I mean you have to be incontinent for your bladder to show up on it. Never mind the fact that you may pee 30 times per day (and night), or that you are always constipated unless you eat like a goat. Also, how do you measure spasticity, pain, and loss of balance? I know I'm bitching and not offerring up a solution, but I really do get frustrated at those things. Oh well, since it was worthy of an article from the great and powerful NMSS I'm sure it will get some attention! Sorry for the ranting sidebar.

Lew

[IHaveMS-com]

I got 60 out of 60 on my last one and since it was a Friday and only trial patients were there, the research coordinators both took it and never got 60 (I'm seriously patting myself on the back here). I was feeling like a pretty smart feller'!

Lew, It is nice to score a perfect, but there is no room for improvement and only one direction for your scores to go in the future. I won't say that I am glad I never had that problem, but I never had that problem.

They also do some darned test where they tell you three words and talk to you about five minutes and ask you what the words were.

Bob, That is called in mini mental exam. Besides the 3 words, I am asked to spell a word forwards and backwards.

[Lyon]

Yes, those tests can be frustrating. I got 60 out of 60 on my last one and since it was a Friday and only trial patients were there, the research coordinators both took it and never got 60 (I'm seriously patting myself on the back here). I was feeling like a pretty smart feller'!

Gee whiz Lew, I'm going to have to muster up more respect!

Attention Deficit Disorder wasn't invented when I was in school but as an adult I've had a ton of people tell me that I could be the poster boy for ADD. I exel at things I'm interested in and I can't force myself to suffer through things I'm not interested in...and I DON'T LIKE numbers! I've just got so many uncontrolled thoughts going through my head that things I'm not interested in don't make enough of an impression to etch into either my short or long term memory (in other words, I'm dumber than a rock!)

I agree that EDSS testing could stand to be severely upgraded, but then again I'm seriously hoping that MS isn't going to be an issue much longer and, at least for MS, EDSS tests will become obsolete

I hadn't noticed earlier Lew Einstein.....I'm to believe that you aced the PASAT test and you keep forgetting to log in before you post??
Bob

[Lyon]

Bob, That is called in mini mental exam. Besides the 3 words, I am asked to spell a word forwards and backwards.

Hi Tim,
That's right, I forgot about that one (I guess that's no surprise!). If they wanted me to spell my name backwards I could probably do that....Bob, boB.

If they wanted me to spell Robert backwards they'd better supply a pencil and paper!

It's really kind of insulting that my wife complains how MS has ruined her memory when her memory is so much better than mine.

From now on I think I'm going to sit in the waiting room and read PEOPLE magazine during those torcherous tests. I'd much rather spend my time submersing myself in Paris Hilton's and Brittany Spears latest indescretions (GAG!)

Bob

[IHaveMS-com]

To answer the "pretty smart feller" that forgot to sign in,

The stuff is free until it gets FDA approval. I think the Government would get a little upset if a company was charging for something that had not been approved.

Any insurance company that pays for the CRAB drugs will certainly pay for Tovaxin. I would not expect any type of discount for being in the study.

I expect to be on Tovaxin for the rest of my life, or until something better comes along. Two patients from the 1990 Baylor study who were tested for the redose study were no longer producing MRTCs. I think that will be more the exception than the rule, and if you stop producing MRTCs, I think it would be a good idea to get your blood checked on a regular basis.

I believe I read in the current protocol that if the patient stops producing MRTCs, they will be tested every 2 months to see if they start again. I think the 2 months are relative to the study and would not be the frequency used after the study.

[Loobie]

Bob,

I'm pretty much ADD too (as evidenced by my login failures!) but I definitely love me some numbers. I think all adults who have children and a job are somewhat ADD just by conditioning from constantly doing three things at once.

The key to that test for me is to say that second number under my breath. Like they say 4.....3...and you say 7. After saying seven I say the three under my breath and wait for the next number. I agree with Tim that it puts me in only one position in terms of improvement, but I am one of those people who love tests. Strange I know, but I always have. I guess I'll be concerned if I get a 40 on the next one, but as long as I stay at 55 or above I don't think they would notice it as being statistically significant.

[CureOrBust]

Two patients from the 1990 Baylor study who were tested for the redose study were no longer producing MRTCs. I think that will be more the exception than the rule, and if you stop producing MRTCs, I think it would be a good idea to get your blood checked on a regular basis.

The concern here would be, that in the beginning of the current trial, many "first timers" were "not producing MRTC's", although obviously they still truly were.

[Lyon]

Thanks for the additional info Tim, always good to hear it! It's impossible to imagine what the future is for Tovaxin but if things continue as they seem to and it gets the FDA approval I wouldn't be surprised to see an MRTC test which could be done at home or at least in a local Dr's office in the future. I'm sure that FDA approval and a little time and it won't require all this rigamarole necessary for a clinical trial and one central location creating the treatment.

Lew, thanks for the humor and you're right, kids and a job require multitasking for sure! Thinking about all this testing made me think back on when I was younger. After being pulled over by the police, possibly due to my following non-existant curves in the road, the officer instructed me to say the alphabet backwards. A bad thing about alcohol is that it interfers with the thought process and sadly I loudly responded that I couldn't say the friggin' alphabet backwards even if I wasn't stinking drunk. Evidently the officer liked me because he gave me a ride in his car after that and provided lodging for the night

In retrospect, I'm not sure that anyone can say the alphabet backwards but evidently the police long ago realized that only the drunks respond that they couldn't do it even if they were straight.

It's a clear case of taking advantage of the alcoholically challenged if you ask me.

Bob

[Lyon]

I wanted to bump this up so that Tim would have more chance of seeing it. Don't know if you can answer it or not.
Bob

Two patients from the 1990 Baylor study who were tested for the redose study were no longer producing MRTCs. I think that will be more the exception than the rule, and if you stop producing MRTCs, I think it would be a good idea to get your blood checked on a regular basis.

The concern here would be, that in the beginning of the current trial, many "first timers" were "not producing MRTC's", although obviously they still truly were.