First extension dose today

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby Sweetyhide » Fri Apr 04, 2008 2:40 am

Put the phone down and enjoy your vacation!

I gave blood to test for the MRTC's on Feb 7th. Called my coordinator because it was taking too long to hear back. She emailed them and they faxed her back with the go ahead on March 28th.
I just got the LifeBlood call (with questions) on April 2nd. Waiting on scheduling.

Have a great vacation!
~Sweety
Peace, Love and Potato Salad
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Postby Loobie » Fri Apr 04, 2008 2:48 am

Marcia,

Go back and read some of my insane rantings from around X-mas. By the time it was all said and done, the delay was four weeks. I TOTALLY understand how you feel. It was always my feeling that THEY should be the ones in a rush because they need to get this to market to make the $$$$$. After I couldn't take it anymore I called Opexa and within 24 hours I had received a call from Lifeblood. I'm not saying make yourself crazy like I did, but if you just can't take it, give them a call. Even if they would have told me about more delays, at least it would have been better than silence. I just wanted to know that the wheels were still turning.
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Postby ssmme » Fri Apr 04, 2008 7:41 am

I don't understand this "getting the boot thing". Now there's more to worry about than just making MRTC's. Now we have to worry about not getting into the extension study for "unknown" reasons. This is a roller coaster ride!!

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Postby Loobie » Fri Apr 04, 2008 8:22 am

Amen to that. Someone on here posted a link to an article discussing the "psychology" behind being in a double blind trial. It was pretty spot on. I reserve the right to go back on this statement, but for now anyway I can say I would never do it again just for all the stuff that I did not anticipate. You are correct in your analogy, it is like a roller coaster.
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Postby Lars » Fri Apr 04, 2008 5:45 pm

Lew,
It's been a long and trying road, I couldn't be happier for you! I'm really excited now that open label is gathering steam, we will finally get a good picture of what Tovaxin really does. I probably missed some posts but my coordinator assured me that negative mrtc's does not eliminate one from open label. Blood continues to be drawn and when and if there is a positive mrtc panel, vaccine will be produced.
To Lew and everyone on the open label road, yeeehawww! (sorry, old rodeo cowboy to the grave I suppose)
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Postby av8rgirl » Fri Apr 04, 2008 8:06 pm

I posted on the sticky already so you can read about my Phase IIb experience!

I had my last Phase IIb blood draw on April 1 (yep April Fools' Day!) and was told I should know in 2 weeks if I am still making MRTCs for the Phast III study. The study coordinator will call me.

The neuro also said that it is quite common for people in the IIb study to convert to not making MRTCs during the trial. He said I would be retested in 30 days.

My question is that during the IIb trial, they drew 11 tubes of blood to test for MRTCs every visit so they would know after each visit if the study patient is still making MRTCs, so why would they continue you in the trial if you were NOT making MRTCs?

From what I've read, you can be booted for testing positive for the listed STDs, Hep B&C, West Nile Virus, CMV, a couple of other things, getting PG or fathering a child, low white and/or red count...but I didn't read anywhere about not producing MRTCs. Can someone explain that to me?

Or am I opening a can of worms that I shouldn't? Let me know...ok?

Glad to find you guys... :D

(edited to clarify the blood draw!)
Last edited by av8rgirl on Sat Apr 05, 2008 7:51 am, edited 1 time in total.
“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 Loobie » Sat Apr 05, 2008 4:43 am

It's already been opened :lol: . Seriously, don't be afraid to ask any question here. That's why all of us frequent here so much. You can expect to get it pretty straight here. However, we are fervently trying to figure out all the things that can get you booted. I'm going to go back and read my Integreview stuff I had to re-sign again for the extension. There may be some more clues in there. Good luck in the extension! If you've already had your draw, you are getting close. It took me about 90 days after blood draw to get stuck, so hopefully your cells "do their thing" faster than mine did. I'm hoping for good stuff. I went from a 1.5 to a 4 from the beginning of the trial to now (and am still there as of my appt. Wednesday) and would abolutlely give an arm to get back to a couple of points lower.
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Postby av8rgirl » Sat Apr 05, 2008 8:01 am

The study coordinator has been very upfront with me with any questions I have asked as well as informing me of any reasons for being booted.

So that's my story and I am sticking to it! LOL!

I was aware that there was some concern in the beginning about patients comparing the color of their vaccine but duh! why would a company not make the vaccine in a double blind study the same color for everyone? Is this an issue that has been beaten to death already? Sorry if it has. ;-(

A friend of mine writes protocols for clinical trials and she was very surprised by that as it should never have occurred.

Anyway, if anyone has any questions of me, please feel free to ask. I started the whole pre-testing in Jan of last year and finished on April 1 of this year. So it's been a long 16 months!

Looking at the stats that are being presented at the AAN conference, I think this is exciting news.

I look forward to Phase III.

Good luck to everyone else!
“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 TWG » Sat Apr 05, 2008 8:32 am

The study we are transitioning into is not phase III, it is classified still as a phase II because is still has 150 patients by invite only, us. See http://clinicaltrials.gov/ct2/show/NCT0 ... xin&rank=2 Phase III needs 1,000-3,000, I don't think Opexa has that kind of cash. I think of myself as a guinea pig in this study, thus the picture. hope the web site answers question about our study. "By invitation only", makes it me feel high class!
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Postby ssmme » Sat Apr 05, 2008 9:59 am

I feel like I'm back in college trying to get into my chosen sorority. I got my first bid but am waiting to get the next call back. Someone in an earlier post mentioned different reasons you could get the boot. My red cell count was low at my last visit but never was before that. I hope it's not enough to boot me. I don't recall how far the bootees got into the protocol before the boot. Did they get to the big blood draw or was it after the last IIb visit?

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Postby pvns2005 » Sat Apr 05, 2008 11:25 am

With me, I did donate my blood. I got the boot 3 weeks before my first extension study injections. I was booted because of "safety reasons". It will be 6 months before my IIb trial data will be released then I should know what the "safety reasons" were. you should not worry and just go with it. Clinical trials can be a crap shoot sometimes.

Keep the faith Marcia
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Postby av8rgirl » Sat Apr 05, 2008 12:01 pm

You are right, this next phase is technically called OLTerms...OpenLabel Terms. I apologize for calling it Phase III.

I was not aware it was by invitation only. I see that it is in big red letters at the top of the clinical trial information. Thanks for posting that.

I am the one who mentioned the different reasons for being "booted." These were explained to me by the study coordinator.
“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 Loobie » Sat Apr 05, 2008 12:55 pm

The color thing has been kicked around quite a bit. My research nurse told me I wasn't allowed to turn around and see the syringe, while others actually had to look at them and initial something. I agree with Chris, there needs to be a definite sense of just going with it since his "booting" occured so late. That's a hell of a lot easier for me to say now that I have received my first injections, but I still won't feel good until I feel good!! Getting kicked out after you've already done the second draw should give us all pause basically showing that you can get kicked out at anytime.
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Postby Lars » Sat Apr 05, 2008 2:01 pm

av8rgirl,
A quick thought on the "why would they keep you in the trial if you are not producing MRTC's". It is an extension, they can't recruit more patients. I would guess that for Opexa, it is a great source of information to follow the "path" regardless of MRTC levels. Also, the thought of not producing seems like the goal to begin with. The other thought is that they are a conscientious pharma and really care. The getting "booted", as is seems to be labeled, might be the argument against that theory. I am HUGELY confused about the getting "booted" criteria.
Well Wishes To All,
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Postby ssmme » Sun Apr 06, 2008 5:44 pm

Lars,
You are confused as I am. If someone can shed any light on this please let us all know. Is there something else? Did everyone who got booted come from the same site? Did the bootees get any information on a possible reason for rejection? Lack of MRTC production doesn't sound like the reason for the boot. What do the people who were rejected think the reason is?
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