Tovaxin trial
 

Hi Everybody,

My neuro is going to test me for the Tovaxin trial. I go in November 24th to sign papers then they have to see if I produce the T cells. I have done a trial before so this isn't all new to me.

Wish me luck on those T cells! :rolleyes: :D

Good Luck Ewizabeth!

Let us know how things are going for you.

Keeping everything crossed for you, Ewizabeth.;)

Yes, please do keep us informed. I think this trial is a good one.

Thanks LeeAnn! I hope it works well, I don't feel great now, but maybe this will be the good treatment for me.

Thanks Sally, I hope it turns out to be a great treatment. My neuro is really hopeful for this one, he was involved in some early trials in the mid-90's, so he has been following this for a long time.

Good luck on the study! I have talked to one person that has been it for quite some time and doing very well. I know of two others that are accepted and are doing the test for the T cells now.
I wish you all the best, it looks very promising.
Pat

Thanks Pat!

Just four weeks to go until my sign up appointment. :)

This is great, Elizabeth. I am so proud of you for being a pioneer for the rest of us.:)

I saw the video about Tovaxin and they made it all look so simple. If it works as they say it should, then this looks very promising.

I'm not crazy about any Med that messes with our Immune Systems, but if these Killer T-cells are the reason our myelin is being distroyed, then I say,, "Off with the little bastid's heads.:D

Much Luck and Love to you Wiz.

Sally, you have such a cute little way of cursing. :p :D

Elizabeth, I sincerely hope you get into this trial.

I have a few other friends who are just awaiting their results, to see if they have been accepted. I was also very friendly with Tim a year or two ago (he was one of the first to try it) and he has faired very well.

I think this might turn out to be our ticket!!! If not, the risks seem so minimal/non-existent that at least you are unlikely to suffer any ill-effects.

Good luck!

Cherie

Hi Sally and Cherie,

Thank you, I hope I have enough of the little bastids to get into the trial. :D

I read Tim's story and it gives me hope. It would be nice if they could help more people with MS with this treatment. I hope it does as well as they expect it to. I hope your other friends can get into the trial too Cherie.

Cherie, mark one of your friends out on waiting for their results. I am in. Just found out today. I am so excited.
Good luck to you Ewizabeth!

Sweety,

Again, congratulations!! :D I'm very happy for you! Keep us posted on your progress!

Nice going, Sweety.:D Please do come back and let us know how it's going.

Much luck to all our Pioneers. Still keeping everything crossed for you Ewizabeth.

Thanks. I had started a blog about it and now that I actually have something to write about I put the link in my profile.

Thanks Sally. You're a sweety! :)

Sweetyhide, I read your blog, it's nice of you to keep your progress up like that online. I subscribed to it with my Yahoo account. I'll be rooting for you from the sidelines! I like your many kitty pictures!

I am so happy for you SWEETY!!!!!!!!!!!! CONGRATULATIONS!!! If I wasn't doing so well on LDN, I think I'd be trying to find a way to get myself.

Elizabeth, I sure hope you and my other friend Debee get in too!

As far as the T-Cell testing, I'm wondering if anyone knows enough about this blood test; whereby you have to be producing some sort of T-Cells () to be accepted?

This is above my head at the moment, but for me, it begs the question of why they don't use this testing to help dx MS, if it is a major factor for being accepted into this trial?

http://www.nationalmssociety.org/Sou...-T%20Cells.asp

http://ihavems.com/

Thanks, Cherie

Cherie,

If they find that this works the way they think it does, then maybe it will be used to diagnose MS at some point. I wonder what the cost of doing the test is? Since this is experimental so far, it could be a cost prohibitive test at this time. If it does work well, and the test becomes commonplace, then it would make sense that they could also use it for the diagnosis process.

I know that doesn't really answer your question and I hope a person who is more scientific than me will jump in here. :)

I hope your friend Debee gets into the trial too!

Tovaxin
 

So happy for Sweety on getting accepted into the Study for Tovaxin. Ewizabeth, I am hoping you also make it in. :)

I have a friend that wanted me to Post this here hoping it might help answer questions about the vaccine.

"One of the protocol criteria is that the patient can produce T-cell vaccine. To be able to produce T-cell vaccine, the patient must have myelin reactive T-cells. Myelin reactive T-cells as the name implies are T-cells that when introduced to human myelin react as if myelin is a foreign intruder."

Is it okay to Post a URL? :confused: Hope so. Thank You!!

http://www.clinicaltrials.gov/ct/sho...245622?order=1

I see that one of our local Neuros is part of the study. If I were under 55 and still RRMS, I would jump on it.:) The center is about 20 miles from me.

I will make sure that local PwMS, who fit the criteria, are aware of this.

Thanks for posting and yes pertinent links are allowed here.:)

Ewizabeth..YoooooHooooo!!! How did the test go, yesterday? Did they find enough of the little bastids to make your vaccine?:D

Hi Scotch Lass and Sally, :)

Well, all that happened is we went over the details of the trial, checked my history to make sure I'm eligible and I signed the paperwork.

I stopped Copaxone, and also Nasonex, since it has a small amount of steroids in it. I go back December 29th for the next steps, which includes the initial pint of blood to see if they can make the vaccine. We are hoping for many little bastids... I must have lots of the little bastids!! ;)

I'll keep you posted to whatever happens next! Thanks for thinking of me ladies!

Thank you Scotch and Cherie.

I have to admit I am not very good at waiting.
The way I figure it maybe around Christmas or towards the end of the year they will be calling. (???) They did say it might take longer. Just depends on how it all goes I guess.

E, I will be crossing my fingers you have the rouge cells. Sounds weird to wish that for someone.

Tovaxin
 

Hi all!! A friend of mine that was in the first Clinical Trials for Tovaxin wanted me to post this information here.


TOVAXIN INJECTION SITE REACTION UPDATE

If you visit Tim's site http://www.ihavems.com, there is a link at the top of the page updating a post ut injection site reaction. The reaction he had was actually from the Band-Aid and not the vaccine.

March 31, 2005 – Three days after Tim received his injection, he removed the little round Band-Aid and discovered that there was redness at the injection site. Dr. Zhang had told Tim that about 20% of the people that he treated in the late 1990s had a reaction at the injection site. The redness was possibly a sign that the army of antibodies were attacking the attenuated myelin reactive T-cells from the vaccine and causing the redness at the point of injection. We were all delighted to see this. It would be 6 months before Tim would receive another injection, and at that time Dr. Loftus realized that the redness was from the Band-Aid and not from any battle between the protective T-cells generated by the vaccine and the injection of attenuated myelin reactive T-cells. Since plenty of time had passed since the original post, it didn't occur to us that we should go back and correct this erroneous observation. Tim has never had any redness at the injection site caused by a reaction to the vaccine. Tim has shown us some websites where people who are getting into the current study are hoping to see redness at the injection site, and he is concerned that if someone in the study does not see redness at the injection site, they will assume that they are in the placebo group. It should be obvious from Tim’s experience that people in the study could see redness caused by a reaction to the Band-Aid or see redness caused by a reaction to the vaccine. The vast majority of patients should not see anything. If you know someone who is in the current study, please point this out to him or her.
This is the remainder of the post from 3/31/05 and the picture of the Band-Aid reaction. Notice how it has the outline of a little round Band-Aid – Tim will have his blood checked 4 months from now to see what level of myelin-reactive T-cells is present. A person with MS will continue to produce these bad T-cells, but by evaluating their blood and giving them the appropriate vaccine booster, the amount of myelin-reactive T-cells will approach zero and the destruction of myelin will stop. By analyzing the patient’s blood every 6 months, the scientist is also able to look for any epitope (we are not going to try and explain that) shifts in the bad T-cells. The person’s vaccine is constantly monitored and adjusted to keep the disease from ever doing damage again. This is personalized medicine. AUTOLOGOUS (the donor and recipient are the same individual) treatments have very little safety concerns, have no rejection problems, and are patient specific. For common short-term diseases, the “one size fits all” types of treatments are effective, but for autoimmune diseases, various types of cancer, and a host of other diseases, making the treatment using the patient’s own cells is a medical missile that is programmed to seek out and destroy the problem.

I have also been waiting to see if I will be accepted to a Tovaxin Clinical Trial. I had my first visit on November 10th and I thought I met all the Criteria but there is a question due to my MRI's. It has something to do with meeting the McDonald Criteria for MS. Something to do with my lesions. I had to have new MRI's taken and sent to the Study Doctor. So I am waiting to see if I will be accepted and if I am, I still have to see if I make the Myelin Reactive T-Cells. So I am just waiting to hear from the Trial Center.

I have believed in this procedure for over 1 1/2 years and I still think it will be a miracle if I get to try it. Might get the placebo, but will eventually get the real Tovaxin.

Hope Tim's explanation helps to clear up some misconceptions. He is a very nice guy and he is still doing well. :)

Thanks,
Scotch Lass

I don't know if it's kosher to drag up an old post but this is the only thread I could find here about Tovaxin, so here goes!

I am also in the Tovaxin clinical trial and am just getting ready for my third vaccine on May 24th.

Is there anyone here besides Sweetyhide that is in?

Scotch Lass, did you ever get accepted? I know that Wiz didn't.

Hi Cheryl, nice to see you here.:)

Do you know if you are on the real thing? How are you doing so far? Any difference? Let us know..K?

:hug:

I don't know if I am on placebo or not. So far so good, I guess! I have been a little sick after each vaccine, fever, achy that sort of stuff. But nothing a couple of advil or aleve won't take care of over a 12 hour period.

;)

Thanks Cheryl, I hope this turns out to be the one for you.:p

I guess we will find out! Anything that breaks the exacerbation cycle that I have been on it good in my book!

Also, anything to help further the cause for MS treatments for others and gets another treatment in the toolbox for the rest of those with this disease is good as well.

It's an interesting treatment.

There is some collateral studies going on at the same time with B-cell vs T-cell theory about MS going on at the same time. I have had some interesting discussions with the neuro in charge of the study. Good guy!

Shot #3 last Thursday. And the MRI was today.

Am I the only member of this forum in this trial?

I was in the original Antegren Trials (Tysabri). As it turned out, I was getting the REAL thing, and did very well on it. I hope the same turns out for you. I had 3 doses of Tysabri after the trial was opened up, but haven't been on it since, as I've been pregnant or trying to become pregnant ever since.

Keep us informed of your progress.

Best of luck to you,
Chris

Thanks Chris. Good luck to you.

Good luck and may God be with you.

Cheryl -- I'm glad to hear things are going well for you! Being you get the reactions following your injection, do you think you may be on the real thing? Would you please refresh my ms memory.....is this just for RRMS or also SPMS?

All the best for a successful outcome!!

Found y'all at last!
 

... thanks to Cheryl who linked me here! :D

I got my second jab(s) last Wednesday. And I swear, people, if I'm getting the placebo, it's the Mother of All Placebos, no doubt about it!

After my first ones on May 2nd, my vertigo was markedly subsiding within 48 hours. Now it still isn't gone completely... but I can stand watching people rock in rocking chairs, watch the trains go by and enjoy the occasional glance of the ceiling fan blades without feeling like I'm jammed up a tree on a 45 degree angle!

The fatigue is rapidly, rapidly diminishing, too. In fact, I can happily tell the difference between "sleepy" and "tired" again and no longer feel like taking another step this far <--> will trigger a whole body implosion with my teeth falling straight out of my head.

And after the shots last Wednesday, my 4 years (and counting) tingles are fading away, too. I still have a little on the right side of my mouth, the palm of my right hand and that big old fat pad on my right knee. But all the baddies on my left side are gone completely. GOOD RIDDANCE to 'em, I say!

Now I could almost agree with a suggestion that I've talked myself into getting better BUT...

... the clinical title of that terrifying/aggravating eye jump... yeah, that. Well, I had my last one a few hours after my first injections and NONE since.

I can't tell you HOW great it is to sit down at my piano and inflict a little tune and family and f(r)iends without losing my place so totally with that eye jump. And since that sucker's involuntary, I'm convinced I'm getting the real juice. It just has to be so! :)

Thanks again, Cheryl, for linking me here. I have SO much to catch up with!

You all (and some of your screen names I recognize from that other board... :D ) are turning out to be the greatest gang! Bless y'all for being here!

And for the record, I'll do everything I can to light a fire under my neuro and the Tovaxin Team to get the parameters expanded and defined for Phase III so we can ALL have a big Tovaxin Party.

As Tiny Tim said, "God Bless Us One and All!"

(Again, it's GREAT to be here!) :)

Sounds good, Jane. Actually making symptoms go away...I like that a lot. I wonder if that stuff would work on and old SPMSer?

So far LDN has kept me pretty stable, but I wouldn't mind it if the tingles died down.

WoooHoooo, Good luck.:)

I'm infamous for "practicing medicine without a license," meaning I have an opinion on just about everything. :D That means I wouldn't be a bit surpised to see Tovaxin (or one of its grandchildren therapies) used in any cases where there are the myelin-reactive T-cells.

I have a sneaking suspicion the parameters for Phase III will be much more inclusive--and if you have a really impatient, aggressive and proactive neuro, this might not be a bad time for him/her to get in touch with the Opexa people and start rattling cages to see if more than RRers can get on the bandwagon.

Our very own Cheryl is living proof of aggressive lobbying--if it hadn't been for her, Tysabri would never have seen the light of day again. Very vocal "reminding" might be just the ticket to seeing if this new gunk can have wider applications.

Here's to aggressive neuros and uppity patients who refuse to accept the status quo! :)

Jane

you give me too much credit, but thanks. There were a lot of us who lobbyied to get Ty back on the market, I just happen to be very vocal about it! LOL! I am still working on it as a matter of fact! :D

Anyway, I am happy to hear you are doing so well in the Tovaxin clincial trial. My only claim is not having had an exacerbation since last December, but I think that is about to end .... sadly .... but I have had a good run. Longest one ever!

It could be that I worked a little bit too long out in the hot sun yesterday, so I am giving this feeling a day or two to see what happens. :(

Really, Cheryl, don't rule "overdoing" out. On Memorial Day weekend, I worked in my mom's yard in 96 degree heat and similar humidity and felt like the very Devil for a couple of days afterwards.

If you have a relatively quick turnaround, you can chalk it up to overdoing. If it starts lingering and lasting like our old flare profiles, well... we'll "over-use" the quota on those little "censored" icons to let it rip with a major rant and whine-fest!

Of course, this all comes down to my seasonal whine of "why couldn't industrialization have led to global cooling?" ARGH!

Thanks Jane. I know I over did and will give myself a couple of days to "cool down." Thank goodness it's about 45 degrees cooler today than yesterday and raining! Nice weather change! Very nice! Seriously, it went from 97/98 yesterday to a balmy 55 right now! ;)

Tovaxin Research data released at Conference!
 

Hi Jane,

I am thrilled to see your results.

If you would like to see the protocol changed for the phase III study, you might look at the protocols that were used for the CRAB drugs and other approved MS drugs. If the age or EDSS span was greater for any of those drugs, present that information to the neurologist at the study site and ask him/her to send this information on to Opexa for their consideration. Please, please, please, won't make anything change, but supportive information might.

I sent you an email. I assume you are the same "Jane the pain" whom I have had emails from.