TOVAXIN GUINEA PIGS PLEASE HELP!

A board to discuss Tcelna as a treatment for Multiple Sclerosis

TOVAXIN GUINEA PIGS PLEASE HELP!

Postby Ant148 » Wed Sep 10, 2008 2:00 am

can all you knowledgeable and experienced folks tell me whose heads at opexa i need to bust to get my freaking questionnaire phone call and my freaking procurement appointment set? i've got major problems going on and they won't call! and yes, i'm mrtc positive big time.

thanks,

ToNY
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Postby Loobie » Wed Sep 10, 2008 3:56 am

I'd start with Shannon Inman. If you look back through some of my Tovaxin postings I have her email and phone number. I never had much of a problem reaching her and shortly after talking, stuff always started happening.
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Postby Lars » Wed Sep 10, 2008 7:12 am

Tony,
Welcome. Shannons #: 281-272-9331 x3405.
Let us know how it goes.
PS You should be ALL OVER your coordinator, it is their job!
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TOVAXIN GUINEA PIGS PLEASE HELP!

Postby Ant148 » Wed Sep 10, 2008 3:15 pm

yeah, that's great and everything but do you guys have any other insights or roads to take? i've left shannon a couple of messages already and she never returns them. what's her email?

meanwhile my coordinator is all over this but helpless as well. apparently shannon told her that i'm on the list and they'll get to me when they get to me. i'm infinitely patient but not when i'm getting worse by the day! do you guys at least know what the steroids policy is AFTER procurement? can i get them right away without penalty? thanks
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Postby Loobie » Wed Sep 10, 2008 5:12 pm

I believe you can, but they'll allow only one course during the trial. I don't know how you are feeling so you might be like, "bring it on", but I do think I remember it being allright either before or after procurement. I remember thinking it's both ways since my neuro corrected me when I told him that I thought I wasn't allowed to get steroids. He said you are, but they have to notify Opexa and they want your neuro. to really feel you really need it. I'll try and see if I don't have Shannon's email at work. I've emailed her before so I know I have it somewhere.
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Postby Ant148 » Thu Sep 11, 2008 8:29 pm

i finally got the stupid questionnaire call. another hoop jumped, now onto the next one -- the procurement call. mr. carter better be at work tomorrow. i swear, this damn trial is set up like a government bureaucracy. :x
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Postby Lars » Fri Sep 12, 2008 9:31 am

Ant,
As long as you have 30 before another blood draw you can do the steroid thing. Not to beat a dead horse here, but your coordinator knows all of this info. If you don't get your procurement scheduled the main Lifeblood guy is Scott and I think his contacts have been covered somewhere on this forum. If you can't find it let me know I may still have it somewhere.
Be Well,
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Postby Ant148 » Fri Sep 12, 2008 5:09 pm

Lars, could you do me a favor and explain like to a child, what you mean by "As long as you have 30 before another blood draw you can do the steroid thing." what exactly does that mean?

my coordinator told me that right after procurement and with opexa's doctor's permission, i can get steroids. of course, none of this is guaranteed but here's hoping.

also, my coordinator has been busting her butt trying to push the process forward but apparently opexa has a specific protocol they have to follow and while they're trying to expedite my case, i'm not getting a call for a procurement appointment until tuesday at the earliest. so the wait continues...
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Postby TWG » Sat Sep 13, 2008 9:05 am

I had a bad relapse during the first IIb, and here is what happened, all coordinated through the site coordinator and Opexa. I got the steroids but then had wait 30 days to be re-evaluated to say I was stable. The Dr. found me to be 'stable' (would not give it to me in writing!). then they ordered the vaccinne.


Wed 1/17/2007 Blood draw to make vaccine. MRI.
• 3/2/2007 started a bad relapse, WAS TOLD MY VACCINE WAS READY.
• 3/8/07 Saw Dr. about bad relapse.
• 3/8-3/10 2007 received 3 day course of IV Solu-Medrol, 1gram per day without oral taper. 30 days until re-evaluation to see if this made me stable.
• Fri 3/16/2007 Saw Dr. EDSS 5.0.
• Wed 3/28/2007 10 weeks since blood draw to make vaccine.
• Mon 4/9/2007 30 day mark since last infusion.
• Tues 4/10/07 Dr. found me stable. EDSS back to 3.0. Vaccine ordered from Opexa. Was told I will get MRI, tests, blood, pee, and vaccine!?! 5/3/2007.
• 5/3/07 received first ‘Tovaxin’ shot @13:09. Did MRI, peg test, math test, MSQLI, speed walk test, pee, and 19? vials of blood. EDSS 3.0. (Visit 4)

Hope this helps.
Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Postby Lars » Sat Sep 13, 2008 9:12 am

Ant,
Sorry for the typo. It should read 30 days. Please know that this is 11b protocol and I am assuming it is still valid. If a patient needs a steroid treatment there is a mandatory 30 day suspension from the trial at which time you can re-enter the trial as long as your blood is clean. Because you will have 10 weeks or so after procurement, you should have no issues. I had to do a clinic visit for an exacerbation evaluation. My trial Doc prescribed the steroids. Good luck and let us know how it goes.

PS. As an afterthought, TWG is obviously a much better record keeper!
Ant, how did 11b go for you before this attack, better, worse, no change? I know more than a few of us here went through steroid treatments and assumed we were placebo patients. It is possible that only placebo patients gather here as those on drug are out partying! Maybe you could do a short post as to your experience.
Peace,
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Postby Ant148 » Sat Sep 13, 2008 10:25 pm

thanks so much, guys. so i gather from what you write that i should be able to get steroids immediately after procurement and it won't affect my vaccine schedule one bit, right? and a few other questions:
*does anyone know if a 3 day course of steroids is as good as a 5 day course? i've always had a 5 day course before but i'd love to get less if it picked me up off the ground just as well as a 5 day course.
*the trial doc can prescribe steroids? mine is always pushing any treatment responsibility onto my regular neurologist. i'd rather get it through the trial doc if you can't tell.
*think docs can prescribe steroids after a phone consult? i'm in such bad shape, i'd hate to haul ass all the way to their offices.
*anybody know anything about LDN? maybe just maybe i made a grave mistake by taking it all through the trial even though it wasn't allowed. it was my insurance policy in case i was to get the placebo but now in analyzing why i'm in such deep doodoo, i'm thinking maybe that was a terrible mistake. i did do research prior to this whole endeavor and didn't seem like there was any conflict but who knows -- maybe i was wrong? oh and then there's a bunch of supplements i've been taking too that weren't exactly permitted. am i really paying horribly for disobeying?

as far as my IIb trial story, it was uneventful (other than the arduous mri's) until a freight truck hit me head on, figuratively of course. upon analysis as to what may have started this awful relapse, i was fairly certain it was an accidental injury to my big toe which sparked my immune system to go into overdrive which in turn sparked this awful downfall. but after more analysis, i've come to the conclusion i have no freaking idea what went wrong. i just know i need steroids like fish need water.
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Postby Lars » Sun Sep 14, 2008 10:00 am

Ant,
I've only ever done the three day, I suppose it worked ok but have no 5 day treatment to compare. How is your relationship with your trial Doc? Mine has been super and she wanted me on treatment asap. She called it in, had it shipped to my hometown and set up a nurse to bring it to me and start the IV. By the way, after all that my trial Doc is now my primary neurologist. I may be worth asking????
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Postby av8rgirl » Fri Sep 19, 2008 6:54 pm

Hi --

I've done 3 day and 5 day, as well as pulse steroids (one day a month for 6 months). I did not tolerate the 5 day at all either time I did it. I ended up with thrush (yeast infection in my throat -- nasty nasty nasty stuff and very hard to get rid of!). And I did not have any better results from the 5-day course than I did with the 3-day course. Given the choice, I would just stick with the 3-day.

I also don't do oral taper after the IV steroids. They make me really sick and I get no lasting benefits from the oral prednisone. Some docs think you need the oral to come down off the IV steroid high slowly, but I don't get that high so no reason for the oral. The oral is more harmful to me in the short run, and the long run if you look at the damage is does to your bones.

That's my experience with IV steroids.

Also, about your LDN question - the doc running the trial said it's not approved for MS and I would be kicked out of the trial as it's not FDA approved.
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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Postby Ant148 » Sun Sep 21, 2008 3:10 am

thanks for the input, av8rgirl. seems like i've broken/continue to break every rule of the Tovaxin trial and i sure hope nobody knows me here ;-)

oddly enough, the recent IIb results sorta make me feel better about all the clandestine rule-breaking i've engaged in. maybe not of it affected anything either way or maybe it even saved me from a worse decline than the one i actually experienced. don't bring up the third option, ok? need to stay positive, you know?
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Postby patrickm » Sun Sep 21, 2008 6:41 am

Having slept on it, I will address the elephant in the room and it's not cute, winky, or funny.

If you are taking actions that skew your data, then you are selfishly ruining the entire purpose of the trial for everyone else.

I don't normally begrudge anyone from doing what they need to do to advance their own health, but in my view you are fucking with all of us, and the prospects of others who are not in the trial, by taking your selfish actions.

I'm rarely surprised at the selfish behavior of others, but after being as conscientious as I have been over the last 20 months, it pisses me off in no small order to read crap like this, ESPECIALLY after reading Opexa's top line data. If you were getting vaccine and also taking something outside protocol that somehow made it ineffective, it skewed the data to show it less promising. If you were getting placebo and took something outside protocol that kept you from relapsing, then that also skewed the data.

As my doctor said, people on placebo and doing poorly are just as important to the study as those on vaccine and doing well. And now if you look at these results, you can clearly see that is true. 1/150 is no small percentage. If you have been reading this forum, you can see the agony of some who have not done well throughout the study, or whose loved ones have not, and they stuck through in the belief that the study was important and that even if they were on placebo, they would be getting vaccine in year two. For me and my family, we had many, many days and nights wondering if I was doing the right thing for myself by jeopardizing my short and long term prospects by enrolling in a study with placebo. We stuck with it because of the promise of year two vaccine AND because we thought it was the most promising prospective treatment on the way up and thus it was important work that needed to be done.

If your selfishness helped in some way to cause these disappointing top line results, then the repercussions are tremendous to the health and well-being of those both in the study, and those outside it who are in terrible need for a working therapy and pinning their hopes on the results of our study, and there are many, MANY of them. Then for good measure throw in the huge financial loss that the company and stockholders took as well, making it less likely that they'll be able to continue with OLTERMS, much less Phase III.

The study also clearly says that you can pull out at any time, which means that if you started the trial and did poorly, you are free to leave and try other options to protect your own health. No one held a gun to your head and made you sign those papers at the beginning of the study. In short, I see no excuse for your actions here, and you have let your own exceedingly selfish goals top the whole reason for the research.

I'll let those with MS outside the study who were hoping to see positive results that may have been skewed by your actions, speak for them selves. But for all of us who followed our protocol to the letter no matter the personal ramifications, my reaction begins with F and end with U.

If you have any scruples, and at this point that seems doubtful, then you'll admit your behavior so that your data can be pulled out of the mix and the results can be rerun properly.
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