Tovaxin Open Label Extension Schedules

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Info for the group schedule...

Postby HEC » Tue Oct 14, 2008 9:47 pm

Hi Mike. I'm Heather (HEC) in Seattle, and I continue to be MRTC negative with my final MRTC test coming up on December 12th. I've actually had three MRTC tests so far in the monitoring arm phase of the trial. I had my second ever MS attack in July 2008 (exceptionally mild and hardly worth mentioning compared to my first attack), and they tested me right away for MRTCs, but I was still negative. I found out on September 29th that I definitely got the vaccine in the IIb phase. I received my third MRTC blood test results on October 8th, and I'm still negative.

For the Seattle area study participants, there were 6 people total, 4 of whom received vaccine and 2 placebo. Both placebo people and one vaccine person tested positive for MRTCs and immediately went back into the vaccine phase for procurement and vaccination. I'm not sure if their shots have started yet, but I assume so. Another vaccine person has since tested postive for MRTCs, so that person is also back in the vaccine phase undergoing procurement and vaccination. That leaves me and one other person who continue to be negative, and both of us have our last monitoring visit on December 12th.

I've made arrangements to have an office visit with MRI on the same day as my last clinical trial visit so we can really see where I'm at with my lesions compared to last year's scan. Hoping it will be the same result as last year where there were even fewer lesions. Fingers crossed!
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Re: Info for the group schedule...

Postby av8rgirl » Wed Oct 15, 2008 3:49 pm

HEC wrote:Hi Mike. I'm Heather (HEC) in Seattle, and I continue to be MRTC negative with my final MRTC test coming up on December 12th. I've actually had three MRTC tests so far in the monitoring arm phase of the trial. I had my second ever MS attack in July 2008 (exceptionally mild and hardly worth mentioning compared to my first attack), and they tested me right away for MRTCs, but I was still negative. I found out on September 29th that I definitely got the vaccine in the IIb phase. I received my third MRTC blood test results on October 8th, and I'm still negative.

For the Seattle area study participants, there were 6 people total, 4 of whom received vaccine and 2 placebo. Both placebo people and one vaccine person tested positive for MRTCs and immediately went back into the vaccine phase for procurement and vaccination. I'm not sure if their shots have started yet, but I assume so. Another vaccine person has since tested postive for MRTCs, so that person is also back in the vaccine phase undergoing procurement and vaccination. That leaves me and one other person who continue to be negative, and both of us have our last monitoring visit on December 12th.

I've made arrangements to have an office visit with MRI on the same day as my last clinical trial visit so we can really see where I'm at with my lesions compared to last year's scan. Hoping it will be the same result as last year where there were even fewer lesions. Fingers crossed!


Hi Heather

I just had my 3rd redraw 3 weeks ago for the extension study and am waiting for the test results. I have also tested negative twice and since the end of my trial (April 1st). I also found out during the unblinding 2 weeks ago that I received drug not placebo.

I had one recorded exacerbation during the trial, and one after my trial ended (mid April this year so it doesn't count for the Phase IIb trial).

I am wondering why you say that since you have tested negative 3 times, that this is now your last visit. Are you done? You cannot continue or you chose not to continue?

The information I am receiving is so conflicting that I am afraid to ask questions anymore for fear of being bounced.

If I test negative this time, I don't know what my future holds as I have been told that I have no "rights" to any of the trial data which includes MRIs. I feel like I am on my own from now on if I test negative this time.

I just don't know what to do...
“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 Lars » Wed Oct 15, 2008 4:15 pm

HEC & Ave8ergirl,
I know there is huge amount of questioning your future right now, but I have to say from an outsider point of view (placebo dude) I am inspired by the fact that you ARE NOT producing MRTC's. I was an inch from leaving the study and I think this to be a good thing, not a bad thing. Tovaxin, at least for you, seems to be doing what we all hoped for. Thank you both for sharing.
Peace,
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Postby av8rgirl » Wed Oct 15, 2008 4:41 pm

Lars wrote:HEC & Ave8ergirl,
I know there is huge amount of questioning your future right now, but I have to say from an outsider point of view (placebo dude) I am inspired by the fact that you ARE NOT producing MRTC's. I was an inch from leaving the study and I think this to be a good thing, not a bad thing. Tovaxin, at least for you, seems to be doing what we all hoped for. Thank you both for sharing.
Peace,
Lars


Lars

Thanks. I want to stay IN the study. See my new thread.
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Postby av8rgirl » Thu Oct 16, 2008 12:23 pm

Tested negative again. #3....next redraw is Jan 6th 2009.
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Postby Sweetyhide » Tue Oct 21, 2008 6:08 am

4th treatment tomorrow for me
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Postby TWG » Sat Oct 25, 2008 9:54 am

I received my first dose in the OLTERM study yesterday 10/24/08, starting the 100 day stopwatch. The Neurologist was out sick, trial coordinator had no sleep the night before. Also the RN who gave the shot had lost her tooth the night before and had went to the dentist and had surgery on the jaw bone. After my 17 vial blood draw stated was surprised could the blood draw still feeling the affect of the anastesia, was glad I was told after the fact. Did an outstanding blood draw, as usual, despite of the situation.

The only reason anyone was at the office that day was to give me my vaccine. Everyone went home shortly after I left. I have a truly a dedicated staff. I was humbled and thank after the fact on my 6 hour drive home.
Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Postby Lars » Tue Nov 04, 2008 10:33 am

I received my 1st non-placebo vaccination Oct. 30, 2008. TWG, I'll see you next month. Our timetable has apparently evened out.
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Postby TWG » Tue Nov 04, 2008 11:36 am

My number 2, no pun intended, is on 11/22/08 at 1:45. I think hurricane Ike, along with Life Blood Neurotics, delayed me much. Hope all is well.
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Postby Sweetyhide » Tue Nov 04, 2008 12:22 pm

My fifth and last shot is Jan 6th. I am not sure why the 2 month wait - then wait 2 more months for a final edss.
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Postby Lars » Tue Nov 04, 2008 4:25 pm

TWG,
Mrs. D told me we were both on the 21st, sorry if that is not so. I was hoping to see you. Happy trails all the same.
Hey, by the way, vaccine burns when injected as opposed to placebo. At least I get that much out of it!
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Postby TWG » Tue Nov 04, 2008 6:22 pm

Lars, your right. 11/21/08 1:45pm. Must have been looking at the wrong month or something. Because I always schedule for my Friday off so the 16 hrs. in the car doesn't wipe me out for the next day of work, and I don't need to take sick time.

I was told 4 weeks between shots, o well. I think there is a little wiggle room of a week, so that's great!

The shot burned in one arm and not the other. Nurse said that was just the way the shot goes sometimes. From my memory of doing my own sub-q shots, that seems to be right.
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Postby ssmme » Fri Nov 07, 2008 1:51 pm

I had my 4th injections today. At this visit they did a full edss evaluation plus the long walk but took no labs. It was interesting. Personally I don't feel that terribly different but today my neuro evaluated my edss at 2. At the beginning of IIb I was at 3.5 and was at 4.5 at my 1st extension study shots. I went from edss of 1 at my initial ms dx in August '06 to a 3.5 at my first IIb vaccine in March '07. I can't put my finger on any specific improvement and to be honest I'm not all that excited about this visit because I don't "feel" it.

Sometimes I feel that these tests for edss are too subjective. I sort of think that if I took this same test tomorrow my neuro might grade me a 3. My next vaccine is Jan 28, 2009 so if they do my edss at that visit I'll be able to more easily compare those results to today and I'll keep my fingers crossed that the stay this way.
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Postby CureOrBust » Fri Nov 07, 2008 5:18 pm

The last time I saw my neuro, I asked for an edss. He talked out loud as he was performing the assessment, which gave me an understanding of why he graded me as he did. I would say they would have their explanation of exactly what has changed, in their books. ask.

Though, if you used to be a 4.5, that implies you could only walk around 300m. While a 4.0 can walk 500m. I am a 3.5 and I can walk around 1000m. You are now a 2.0. I know its a lot more complex than this, but it is a rough yardstick you may be able to remember by.
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Postby patrickm » Fri Nov 07, 2008 8:01 pm

Getting my first shot 12/19.

Would have been 11/28 but of course everybody's closed.
Would have been 12/5 but doctor's office is booked.
Could have been 12/12 but I'll be out of town.
So 12/19 it is. A long wait. Another month to play Russian roulette with a loaded gun.
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