First extension dose today

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby Lyon » Mon Apr 07, 2008 7:09 am

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Postby Loobie » Mon Apr 07, 2008 7:10 am

I just got my replies back from Tim and there are some interesting answers to the "getting the boot" questions. I will post at lunch.
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Postby ssmme » Mon Apr 07, 2008 7:30 am

Obviously you have to come to your own conclusions but my wife aren't going to sweat the situation until we see on paper that someone has actually been kicked out of the study and for what reason(s).


Lyon,
I think that since I'm in the waiting period before being contacted about the big blood draw that I'm getting antsy. I would like to get underway on treatment to keep any progression at bay if possible. I guess I feel that getting the real thing will allow me to quit wondering and to get on with my life because I really feel that Tovaxin is potentially the best treatment option that's come along. No side effects of major issue, no radical measures involved, no need for daily or weekly injections. It may not be the cure for MS but it's the most attractive treatment option to come along and one I'm eager to be getting.

BTW It made me sad to hear your trying to "wean" yourself from this site. You always have insightful ways of looking at issues and I like to hear your point of view. Please don't go completely away.

Loobie,
I 'm eager to hear what Tim has to say.


I'll check back in a few hours.

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Postby Lyon » Mon Apr 07, 2008 12:28 pm

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Postby Loobie » Mon Apr 07, 2008 12:48 pm

I got my emails back from Tim concerning the protocols and what can get you dropped. He seems to be doing well and is in Houston getting his next dose, so here is what he said in his first email back to me:

My email to him is light and his responses are bolded. He emailed me back, but then had a talk with someone from Opexa and the little one following this one clarifies the SP question. Here goes:

Hi Lew,

I finally got my first extension dose the other day! I'm so relieved. I followed your "routine guidelines" and made sure I hadn't had any NSAIDS (all the way to 24 hours after as well) and worked out lightly right before my appt. Keep in mind that it its up to 3 doses plus a week to be fully protected. You are building memory T-cells and producing killer T-cells that will take out your MRTCs now and in the future.

I told the folks on ThisIsMS that I would ask some questions from you. There has been a recent rash of people being asked to leave the trial for whatever reasons (when I say a "rash", understand that it's the people from ThisIsMS and that’s all I know of). Everyone who is in the study, whether he or she feels they are doing better or not have an understandable degree of anxiety. I have had numerous people email that they were doing good but were not going to post that for fear of jinxing themselves. You need only watch a batter before stepping into the batter's box to understand superstition and fear of jinxing yourself. It would be nice if these people had posted their good results, but I understand their not wanting to express their good results for fear that it might be stripped away. As a result of the fear of jinxing themselves, most of the posting have been from people who were not doing better. Since it takes 6 to 9 months for the CRAB drugs to be effective, I think it was a good choice for people who felt they were on placebo, to wait to enter the extension study.

One forum poster from a site in Alabama has stated that his entire site of participants got booted out. Now we all speculated that maybe they were all not producing MRTC's anymore. But since it was all five of the participants, it all sounded fishy to me on that basis. That sounds unlikely to me also. The probability that 5 out of 5 people would not be producing MRTCs would be 1 in 32. Do you know everyone who is in the study at your site? I only know half of the people in my study of 18 people and I am easy to contact. HIPAA rules and study protocol would not allow the people at the trial site to tell you anything about other participants. Even generalities about other patients could not be discussed because it might influence how other patients responded.

I'm not asking you to speculate on why that happened in that case since I know you have no way of knowing, but rather if you had any insight as to what things actually CAN get you booted from the trial. Like if you are aware of any types of things other than non-MRTC production at screening that can disqualify you. I'm thinking maybe their site engaged in some sort of protocol violation, whether intentionally or not. Who knows, but some people are getting pretty spooked after that was brought into the foray about an entire site getting disqualified. I'm a little skeptical about how one would actually know that others got booted due to HIPA (sp?) regulations. I know this is a pretty vague request, but I posted to everyone that I would ask you and see if you had any insight. There was one person that was removed from my study because he was an alcoholic. Alcohol compromises your immune system. The site that I was to start my study at was not keeping good records and they were dropped as a site. Unfortunately, the actions of the site affect the patients they treat. Unfortunately, if the site you were being treated at was shut down, the patients who were treated at that site are also out of the study. The FDA would not accept data from a site that was removed for some compliance issue..

Anything you could add may help put some minds at ease as everyone else is starting to get antsy as they approach their blood draw. Several other study participants have contacted me, but they did not post what I said to them. That is their choice, and I do not post private correspondences, but I do tell the people who email me that they can post the email. I may come back to the ThisIsMS in about a week and post some new Q and A. I am in Houston and will be getting my next treatment in a few hours. I will at least post if I have an injection site reaction. I will be shocked if I have one.
Best regards, Tim

And then the last response after he got clarification:

I had dinner with a higher authority, and if you become SP during the trial, you would be excluded from the extension. I still say it is unlikely with the protocol for admittance into the study, that a person would have several attacks with no remission and be reclassified as SP.

So that's about it from what I asked Tim. It does sound like you CAN get booted if they think you 'cross over' to SP.

So for now, all I can update is that the backs of my arms where they stuck me are bruised 6 days later, but I only noticed that by seeing it, they aren't tender at all so that probably doesn't mean squat.

Lew
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Postby Lyon » Mon Apr 07, 2008 1:10 pm

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Postby Loobie » Mon Apr 07, 2008 1:18 pm

Who knows? Maybe his neuro. said he was sure. I guess in that case it sounds like they dq.
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Postby Lyon » Mon Apr 07, 2008 1:40 pm

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Postby Loobie » Mon Apr 07, 2008 2:02 pm

Yeah, sorry, I wasn't specific!
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Postby Lyon » Mon Apr 07, 2008 2:23 pm

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Postby ssmme » Mon Apr 07, 2008 2:50 pm

I spoke to a representative from my trial staff about all of this today. She said a protocol violation could cause a site to be removed from the study and yes unfortunately all participants would also be removed.

As to my procurement, she said to expect another 3 to 4 weeks before I am contacted by Opexa or LifeBlood and indicated they are extremely backed up with many patients wrapping up their IIb protocol.

She said that we should all exercise patience. I guess if I get extremely anxious I'll just pop a "nerve" pill or drink a glass of wine but really I feel much better now. I think I'm going to go outside and enjoy this beautiful spring afternoon here in Kentucky.

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Postby Lyon » Mon Apr 07, 2008 2:59 pm

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Postby IHaveMS-com » Mon Apr 07, 2008 4:07 pm

Hi to all,

First, there are no sites that have been closed. Second, 2 people out of 5 were released from the Alabama site. The HIPAA rules and patient confidentiality will keep the reason for the action unknown.

If anyone had wanted to, they could have called the Alabama site to see if they were still treating Tovaxin patients. This is a list of the sites. <shortened url> You would probably not get much if any information, but I am sure they would verify that they were still a site.

And as for Lyon cutting back on his Internet use, it must have been April 1st when he said that.
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
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Postby Lars » Mon Apr 07, 2008 4:29 pm

Hey All,
I keep seeing posts that seem to assume that not producing MRTC'S can get you kicked out of the trial. Unless my coordinator has nothing better to do than lie to me, which I highly doubt, you will NOT be dropped for lack of MRTC's.
Lars

Edit PS
I was told at the beginning of my enrollment that Opexa actually had the ability to determine what type of MS one had. I recall thinking that regardless of the Tovaxin outcome, that test would be an epic breakthrough. Just thought I would mention it because of the SP diagnosis in various sites.
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Postby IHaveMS-com » Mon Apr 07, 2008 4:50 pm

you will NOT be dropped for lack of MRTC's.


Absolutely positively correct.

If you are not producing MRTCs, you will be retested every 3 months, to see if you start producing them again. To be in the study you had to be producing MRTCs.

Everyone in the study had vaccine made from the original bag of blood. Randomization determined if you received the vaccine or placebo.

I know you are thinking this. Question -- if I am not producing MRTCs, why can I get the original vaccine that was made for me? Answer -- The protocol requires that you are producing MRTCs from which new vaccine will be made.
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
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