TOVAXIN ROLE CALL

ewizabeth · Post by **ewizabeth** » Wed Mar 07, 2007 6:06 pm

Well, count me out. I didn't have enough of the MRTC's for them to make the vaccine for me. I see the neuro in mid April to talk about my options. I'm going to chill out for now. At least I can start taking the Nasonex in the spring if I need to. I'm not sad about it either, there will be something else to come along sooner or later... I just hope that the rest of you who are in the trial will have excellent results, and know that I'm thinking of you.

Lyon · Post by **Lyon** » Wed Mar 07, 2007 7:26 pm

I'm sorry to hear that Ewizabeth, but I'm glad to hear you're not too bummed out.

It's hard to know anything for sure but it "seems" that Opexa is putting a huge amount of effort into perfecting Tovaxin....and obviously it's in their best interest to increase the percentage of MS patients who can use their treatment so even though you're not in the running now, maybe in the near future.

Bob

ewizabeth · Post by **ewizabeth** » Wed Mar 07, 2007 7:32 pm

Thanks Bob,

There might be something similar to Tovaxin in the future as well. If this has good results there are sure to be more in the works.

Lyon · Post by **Lyon** » Thu Mar 08, 2007 6:23 am

ewizabeth wrote:Thanks Bob,
There might be something similar to Tovaxin in the future as well. If this has good results there are sure to be more in the works.

I've seen two or things you're talking about in the works right now.

Someone mentioned earlier that Opexa wants to improve things so that it will work with 95% of the ms population and I hope that means that they already know how to achieve that.

So who knows, maybe in time for phase III? That might be a good test also at that point....get some of the people to enroll for phase III who weren't able to produce enough mrtc's to make the IIb to see what their improved detection rate is at that point.

Bob

ewizabeth · Post by **ewizabeth** » Thu Mar 08, 2007 6:19 pm

Bob,

My doctor spoke with me at the last visit about what I might want to do if this happened... He asked which of the previous treatments I had been on before had been the easiest to take. I have to say Avonex. I really disliked doing the IM shot...

But, I was sick once a week, and that was it.

With Rebif, I sunk into a bad depression. With Copaxone I had increased pain that was so bad I was not exercising, just sitting around hurting. At least on Avonex I was able to feel good a lot of the time.

Another option is just to wait and see how I do without meds for awhile, with more frequent MRI's to make sure everything is ok. My level of disability is not bad for having MS for more than five years... and my last MRI was good. (Although I look like the walking dead most of the time.) That's why he suggested that option.

Today I was thinking about Tysabri... I don't know if I'd want to do that or not though. With my history of med sensitivity I have this tiny nagging thought that I could be the first PML case in a person with milder MS.

Lyon · Post by **Lyon** » Fri Mar 09, 2007 10:03 am

ewizabeth wrote:Another option is just to wait and see how I do without meds for awhile, with more frequent MRI's to make sure everything is ok. My level of disability is not bad for having MS for more than five years... and my last MRI was good. (Although I look like the walking dead most of the time.) That's why he suggested that option.

Hi Ewizabeth,
First, before your attempt is forgotten I want to commend you for educating yourself enough and having the courage to register for the Tovaxin trial. Ten years ago clinical trials were just for the desperate but we are approaching the crossroads in which, using education and caution, someone can enter a clinical trial which might allow them to get an early start on treatments which won't be available to others for many years.

Like you, I'm not convinced that the crabs offer any benefit over non-treatment. If they do offer benefit over non-treatment I'm not convinced that the the benefit is worth all that has to be endured by using them.

Despite that, if my wife wouldn't have made the Tovaxin clinical trial I would have pushed her to get back on one of the crabs "just to be safe". I wouldn't like the prospect of her being on the crabs for a lifetime but I can't imagine the situation NOT changing radically in the next two or three years and I'm convinced that this time right now is one to do everything you can to hold off disease progression for the short term.

You mentioned Tysabri....I've never seen it outright mentioned but to me the pml situation has always obviously been one of over suppressing the immune system by co-treatment. The first telltale sign was that although almost everyone has the pml virus, it previously only became a problem in people with diseases like aids....people whose immune systems were severely compromised. I think there are other valid reasons to be concerned in the use of Tysabri but in mono treatment and with careful monitoring, pml wouldn't be among my concerns.

I know you are a very capable of making any decisions you have to make, but I wanted to add my two cents.

Bob

ewizabeth · Post by **ewizabeth** » Fri Mar 09, 2007 10:10 am

Thanks Bob,

Points well taken. If my WBC history isn't a factor in Tysabri, I might consider it...

BTW, your wife is lucky to have you as her advocate, you're a smart guy and a nice person. Have a great weekend.

Lyon · Post by **Lyon** » Fri Mar 09, 2007 10:24 am

Gosh, thanks Ewizabeth! I hope my blushing isn't too obvious

You have a good weekend too. You get our weather before we do so I imagine as we speak you are experiencing the warmer temps that I'm looking forward to!

Bob

Lyon · Post by **Lyon** » Sat Mar 10, 2007 7:14 am

Hi Ewizabeth,

By not saying something bad about Tysabri earlier I've left myself with the nagging feeling that I've said something good about it.

I honestly don't have anything good to say about Tysabri....but then again I don't have anything good to say about ANY of the drug choices available to people with ms.

Bob

flipflopper · Post by **flipflopper** » Sat Mar 10, 2007 9:01 am

Hi Ewizabeth,

I'm sorry to hear the results of your second MRTC's test.

Before I heard that I was accepted for the Tovaxin trial, I kept changing my mind as to what I would do if I wasn't accepted. It's not an easy decision to take!

Take care,
FF

ewizabeth · Post by **ewizabeth** » Sat Mar 10, 2007 5:27 pm

Lyon wrote:By not saying something bad about Tysabri earlier I've left myself with the nagging feeling that I've said something good about it.

I honestly don't have anything good to say about Tysabri....but then again I don't have anything good to say about ANY of the drug choices available to people with ms.

Bob,

I have been very cautious about Tysabri, even suspicious after the patients had the PML. I saw a link to the report for the May 2007 AAN conference, and the reports about Tysabri look pretty darn good. I know, if I do decide to try it, I'll have the possibility of PML in the back of my mind. But, like you say, all of the drugs that are available are less than desirable. I had bad side effects from each of them. And my neuro would be quick to say, well, death isn't a reported side effect with any of them...

He has patients on it, but he doesn't paint a glowing picture of it, at least not so far when I've spoken to him about it. He has said I could try it if I want to, but he mentioned the risk of PML, and the uncertainty about what else might happen with it in the future. But then again, we had those same thoughts when the other injectables were in their early years as well I'm sure.

ewizabeth · Post by **ewizabeth** » Sat Mar 10, 2007 5:32 pm

flipflopper wrote:Before I heard that I was accepted for the Tovaxin trial, I kept changing my mind as to what I would do if I wasn't accepted. It's not an easy decision to take!

Hi FF,

I'll figure something out... I really don't think I'll feel comfortable with not taking anything. I have had some significant MS attacks in the past, and I don't want to risk another one where I might have some major damage. I haven't had a bad attack since I've been on treatment, and because I've been off treatment since November, I feel like I should do something soon. If I were on Tovaxin placebo, that would be another thing, because they'd be monitoring me so much they would catch anything early on and they could treat with steroids if necessary.

Lyon · Post by **Lyon** » Sat Mar 10, 2007 6:38 pm

ewizabeth wrote:I know, if I do decide to try it, I'll have the possibility of PML in the back of my mind. But, like you say, all of the drugs that are available are less than desirable. I had bad side effects from each of them.

Hi ewizabeth,
I have to admit that it's hard to overlook the reported 66% effaciacy of Tysabri.

You've shown that you're willing to enter a clinical trial if one comes along that you like. With that in mind my gut feeling is that you're not going to have to be on any of these things for too long. Like you mentioned to ff, you don't dare to be on NOTHING for that long.

I'm not sure what these things are worth or if they'll help your decision in any way but they were things I had to consider when my wife and I were considering the year of possible placebo in the Tovaxin clinical trial.....and we had to consider what we'd do if she was on placebo and her ms started progressing like mad during that time.

From what I can tel,l and what seems to differ from the common perception is that some, maybe many, researchers don't feel that steroid use during an exacerbation really reduces damage, they just reduce (hopefully) the duration of the exacerbation and make life easier for the patient.

The other thing is that I've read that after going on the crabs it could take upwards of eight months in the system for them to have full effect.

For me, those two things made enduring a year of possible placebo, very scary and there's no way we would have considered it if I weren't so sure of the actual treatment and the knowledge that she would be on the treatment for sure in the second year. I was gambling that she would be allowed to stay on Tovaxin until it's FDA approved because that's what the company has done in the past, but it was nice to hear Tim later mention it outright.

You're a level headed and intelligent person and it's obvious that you are utilizing all the right thought processes despite the fact that those with ms can only choose between the least shitty of the shitty treatment options.

Bob

Loobie · Post by **Loobie** » Sun Mar 11, 2007 2:14 pm

What Bob describes is my biggest fear right now; having a big relapse (or even a little one if it takes any more vision) and having to stop the trial. I know we can get steroids, but those have never done a thing for my eyes way before this started. I'm going to hang in there no matter what, and if the bad thing happens, I will be the first trial participant in an optice nerve transplant!! Someone has to be working on that, right?.........

Lyon · Post by **Lyon** » Sun Mar 11, 2007 2:39 pm

Loobie wrote:I will be the first trial participant in an optice nerve transplant!! Someone has to be working on that, right?.........

Hi Lew,
I know you're kidding but I wouldn't be surprised if somewhere in the world someone is working on just that.

When my brother-in-law was younger he accidentally stabbed himself in the eye, which blinded him in that eye. At some later point that eye started not tracking at the same rate as the other eye and for cosmetic reasons a surgeon cut some outlying muscles so that it would track with the other one.

As a young adult he wasn't wearing safety glasses when working on a car and a shard of metal embedded in the other eye. Luckily the situation turned out well for that eye, but during that visit the eye specialist told him that if they hadn't done that cosmetic surgery on the first eye, things had changed enough that he could have gotten it working again.

Many times it's been proven that what is impossible and seemingly hopeless today, isn't necessarily the same picture tomorrow.

Bob