EP is a community where members connect through shared life experiences-- like MS--and so much more. You are not defined by any one thing, so be your true self and find others just like you at
Experience Project.
Joined: Jun 14, 2007 Posts: 118 Location: Historical Glendale, OH: Home of the Squirrrels
Posted: Fri Jun 27, 2008 7:56 am Post subject:
Lyon wrote:
... A girl after my own heart......other than the "weakness" shown by asking questions first Bob
That's what "cyber" flame throwers are for, Bob--nothing more than egg-on-face if you pull the trigger and the truth turns out to be... problematic. _________________ Jane the Pain
Joined: Jun 14, 2007 Posts: 118 Location: Historical Glendale, OH: Home of the Squirrrels
Posted: Fri Jun 27, 2008 8:03 am Post subject:
Lyon wrote:
... but the next day she got a call that Opexa hadn't been able to isolate mrtc's (I got the info second hand, so take it with a grain of salt) and that my wife had the option of any other treatment option of her choice OR being checked periodically to see if mrtc's can be detected at some point in the future... Bob
I'd do the waiting game, Bob. Anything can slam those mrtc's, you know. And if your area has been as full of people with viral infections, spring allergies, and the usual slam of post-school strep throat, you may be looking at the "usual suspects" of maskers for mrtc's.
It's a pain in the keester, no doubt of it. If all runs on schedule, I'll be up for shot day on July 23. However, last time around my stuff got seriously delayed. Wonder if that'll happen this time? I'm focusing on Labor Day as a date to assume all will be scheduled--and that means TWO YEARS since I first contacted the study site and nearly 2 1/2 years since I "washed out" the Avonex.
We certainly need to encourage this trial to start moving at "Moderato" rather than "Lento," in my musical opinion... _________________ Jane the Pain
Joined: May 04, 2006 Posts: 3300 Location: Mid-Michigan
Posted: Fri Jun 27, 2008 9:09 am Post subject:
JanethePain wrote:
I'd do the waiting game, Bob.
After the way my wife was pushing to get on Revimmune a few months ago I'm a little surprised that she seems willing to stick with Tovaxin and see what her mrtc's are going to do.
On the other hand, I explained to her that an advantage of Tovaxin's over Revimmune is the very fact that Tovaxin is an ongoing process, and for that reason it's impossible for MS to come back again and do additional unseen damage before being noticed. Evidently that was a strong deciding factor in her mind.
JanethePain wrote:
We certainly need to encourage this trial to start moving at "Moderato" rather than "Lento," in my musical opinion...
Ah Morticia, I love it when you talk dirty....... _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Last edited by Lyon on Fri Jun 27, 2008 5:19 pm; edited 1 time in total
Joined: Sep 16, 2007 Posts: 58 Location: Chicago, IL
Posted: Fri Jun 27, 2008 5:05 pm Post subject:
Congratulations Sweety!
Had my last of part 1, first of part 2 appt today and got the consent form. Now waiting for The Call. <tap tap tap>
Lyon wrote:
At any rate, in the absence of being told anything good with certainty, she hasn't experienced any bad, which can be seen as reason for hope.
I think that is THE reason for hope and I'd encourage y'all to stick with it too for all the reasons already laid out.
Dr. stressed (again) that NOT HAVING MRTCs IS A GOOD THING. Our body can do its repair work. (though I secretly want them to find it in hopes that I'll feel less crappy.)
Was told by my doc that they are now testing for 109 peptides
(see: http://www.opexatherapeutics.com/FOCISTcellPoster2007Final.pdf )
and used to be only 2-4, and he thought maybe 8 by the time I had my blood drawn 16 months ago. He said that they figure only a tiny few of them are actually doing the bad stuff, and if they can nuke those, then it's pretty much gone. The others are non-reactive. He also said that there are people from the Phase I who are still in remission and have not gotten boosters. (!)
He also said that because of the tremendous progress that they have made, even in the last year, that we cannot and should not make comparisons with our vaccine and what has gone before us, either with Phase I/II or even Phase IIb. They have apparently gotten a lot of stuff figured out over the last year. They are thus doing new OLTERMS procurements for everyone regardless of vaccine/placebo in regular TERMS.
He also said that because of all of the blood draws on us, they now have a great library of what's going on in our bloodstream and should be able to nail anything MS related that pops up. He also gave hope, ONLY based upon his past experience and supposition—not from Opexa, that we would be kept in the study for quite a long time if we wanted to be, perhaps even after it goes to market just so they can keep tabs on us. That would be awesome and would go a long way toward making the guinea pig status feel less so.
The doc and nurse also guessed that it might be up to a year before we find out placebo v. vaccine, "to the point where you probably won't care much by the time you find out." So no sense holding our labored breath for that any time soon.
Will post again when I know something worth posting.
Hang in there everybody. We're finally all getting there.
On the day of the appointment we were told that my wife was still producing mrtc's and they would make an appointment for the blood procurement, but the next day she got a call that Opexa hadn't been able to isolate mrtc's (I got the info second hand, so take it with a grain of salt) and that my wife had the option of any other treatment option of her choice OR being checked periodically to see if mrtc's can be detected at some point in the future.
The option of any other treatment would mean dropping out of the extension study. Anyone at any time has the option to drop out of the study and use another treatment. I think having Opexa check your wife’s blood for MRTCs every 3 months is the best thing to do and is consistent with how the results of Tovaxin may evolve for those lucky enough to only need to be monitored.
Quote:
Despite my realizing that an absence of myelin reactive t cells might be considered a good thing, being told that they can't make the vaccine for her was kind of a scary and uncertain situation.......uncertain whether or not "no" mrtc's really meant NO mrtc's were circulating in her system or if it really only meant that mrtc's were there but weren't detectible due to masking.
If your wife has not changed what she is taking, and she is avoiding the list of drugs that Lars posted http://www.thisisms.com/ftopic-3826-0.html (It is about midway down the first page), then any masking she was experiencing would be the same now as when she started the study. It seems that you would need to be taking a significant amount of something on the list before you would down regulate the immune system enough to not be producing a detectable amount.
When I first started looking into masking MRTCs, I thought masking was a means that prevented the MRTCs from being detected. That is partially true. I think masking/suppressing might be better terminology. The drugs in the list above suppress the immune system. If they are able to suppress the production of a particular MRTC below the point at which it can be detected, it has essentially masked that particular MRTC.
Since Tovaxin causes the body to produce memory WBCs that produce T-cells that destroy the MRTCs as they are produced, your wife may not be producing any MRTCs or her immune system has a sufficient number of memory T-Cells to adequately remove the MRTCs as they are produced. I assume there may be a point at which the balance between the production of MRTCs and the amount of memory T-Cells producing T-Cells that remove the MRTCs cancels each other out. This is something that Opexa is trying to determine and it sounds like a few people in the study have achieve that balance.
Everyone is going to build protection against MRTCs differently. Everyone is going to have a different rate at which they produce MRTCs. By monitoring a patient's blood, the amount of Tovaxin needed to keep the MRTCs at or near zero can be determined and the appropriate dose and cycle of vaccine can be determined.
For the current study, I have heard that 25% of the people who were on Tovaxin are no longer producing MRTCs. That is a good thing. Two people who were in Dr. Zhang's T-cell vaccine study at Baylor in the late 1990s no longer produce MRTCs. They will still need to be monitored, but at this point I would say they are in remission.
Tovaxin will evolve. It is patient specific, and as such, each patient will need a certain number of treatments per year to keep the memory T-cells at a sufficient level to control whatever amount of MRTCs are produced.
Hi Patrick,
Quote:
He said that they figure only a tiny few of them are actually doing the bad stuff, and if they can nuke those, then it's pretty much gone.
Your doctor seems to be well informed. The following is from a previous post.
The Tovaxin protocol uses 163 different peptide fragments over 3 of the major myelin proteins to identify an individual’s MRTC set. 109 of these peptides have been found to identify MRTCs. When I started the study, they were using only 6 peptides from one of the proteins for screening.
The initial screening determines if an individual has circulating MRTCs that react with these myelin peptide fragments (called epitopes). A negative result means that MRTCs could not be detected by the assay. The inability of the test to detect MRTCs means that at that time an individual for some reason does not have adequate levels of MRTCs to be detected.
Both people with MS and healthy subjects make MRTCs. In people without MS, the immune system realizes that those cells are "self reactive" and they are not allowed to expand. In people with MS, at certain times and for as yet unknown reasons, these MRTCs are allowed to expand. The body does not seem to have any defense against autoimmune diseases. With self-reactive cells, the body produces them and is not able to realize that they are destructive.
The body produces more than one billion lymphocytes and other immune system cells daily. Since there are approximately only 10 or 20 MRTCs per 1 million WBCs, eliminating them appears to not compromise the immune system, but it does eliminate the pathogenic T-cells that destroy myelin. A flare is when the body produces too many of these bad T-cell _________________ 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.
Joined: May 04, 2006 Posts: 3300 Location: Mid-Michigan
Posted: Fri Jun 27, 2008 7:19 pm Post subject:
IHaveMS-com wrote:
The option of any other treatment would mean dropping out of the extension study. Anyone at any time has the option to drop out of the study and use another treatment. I think having Opexa check your wife’s blood for MRTCs every 3 months is the best thing to do and is consistent with how the results of Tovaxin may evolve for those lucky enough to only need to be monitored.
Hi Tim,
I absolutely agree with what you're saying and I'm glad that my wife decided to stay in the study and be monitored.
I still have to say that despite my conviction that the current situation is favorable, it remains disconcerting to have waited over a year for "the real thing with certainty" only to find "the real thing" isn't coming. At least not in the near future.
Kind of twisted logic on my part I know, but when the price of gasoline goes down, I'm the kind of guy who does my best to run the gasoline out of my car so that I can buy as much as I can while it's cheap
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Every time when my series of treatments have ended and I am tested again for MRTCs, I always have had some MRTCs and new vaccine is made. Before I am tested for MRTCs and before giving a bag of blood for making vaccine, I avoid anything that might suppress my MRTCs.
I think after 20 plus treatments, I would be a little unnerved if I was no longer producing MRTCs. I am pretty sure I understand your concern.
Having MS is like getting into a bed in which you saw a rattlesnake slither into. The snake may never bother you, or the snake might actually snuggle up to you for warmth, but no matter how nicely you behave, the snake, for no apparent reason, might bite you. _________________ 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.
Joined: May 04, 2006 Posts: 3300 Location: Mid-Michigan
Posted: Fri Jun 27, 2008 7:59 pm Post subject:
IHaveMS-com wrote:
Having MS is like getting into a bed in which you saw a rattlesnake slither into. The snake may never bother you, or the snake might actually snuggle up to you for warmth, but no matter how nicely you behave, the snake, for no apparent reason, might bite you.
That seems like a VERY fitting analogy for the cold blooded reptile that MS is.
The only things that have changed are that my wife is on the smoking cessation drug "Chantix", which is new enough that the interactions aren't well known and she has also gotten onto one of the synthetic thyroid hormones.....which might be a little suspect as a masking agent.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Joined: Sep 23, 2007 Posts: 156 Location: Lexington, KY
Posted: Fri Jul 04, 2008 11:35 am Post subject:
I have a question...For those of you that are in the club - how long did it take for your vaccine to be created? Mike Tucker and I had our procurement on the same day within 30 minutes of each other. He will be dosed around the 15th of July. I won't be dosed till around mid August. I hate that I must go thru the whole summer before the first dose. Summer heat during July and August can be awful in KY. I hate the wait. I want my Tovaxin!
Marcia _________________ DX'd 08/2006, RRMS, currently in the Tovaxin extension study group.
Joined: Nov 29, 2006 Posts: 75 Location: Versailles, Kentucky
Posted: Sat Jul 05, 2008 6:43 am Post subject:
ssmme wrote:
I have a question...For those of you that are in the club - how long did it take for your vaccine to be created? Mike Tucker and I had our procurement on the same day within 30 minutes of each other. He will be dosed around the 15th of July. I won't be dosed till around mid August.
Marcia,
It appears as if each blood procurement has its own unique characteristics regarding how long it takes to get to the vaccination stage. At the start of the IIb trial, in my case it took 14 weeks from procurement to randomization and injection stage. This time around it took only 10 weeks. I've done a lot of cell culture work and different types of cells that are grown in culture grow at different rates and that can vary due to a number of reasons such as initial starting number as well as individual characteristics of the cells themselves. This time around I may have had boatloads of fast growing bad guys which sped up the overall process whereas your bad guys were small in number or generally slow growers. I know that doesn't get you to your vaccination faster but it may give you insight into the overall process.
Joined: Jun 14, 2007 Posts: 118 Location: Historical Glendale, OH: Home of the Squirrrels
Posted: Sun Jul 06, 2008 8:51 am Post subject:
ssmme wrote:
I have a question...For those of you that are in the club - how long did it take for your vaccine to be created? Mike Tucker and I had our procurement on the same day within 30 minutes of each other. He will be dosed around the 15th of July. I won't be dosed till around mid August. I hate that I must go thru the whole summer before the first dose. Summer heat during July and August can be awful in KY. I hate the wait. I want my Tovaxin!
Marcia
I hear ya, kiddo. Last time around, I was about 13-14 weeks from "Draculette Draining" to shots with the escalating b/p to prove it!
This time around, I managed a little math and decided if everything ran on Swiss time, I'd get "shot" on July 23.
I haven't heard a word about my date... should I live up to my screen name, be a pest and call 'em? _________________ Jane the Pain
Joined: Sep 23, 2007 Posts: 156 Location: Lexington, KY
Posted: Mon Jul 07, 2008 2:39 pm Post subject:
Quote:
I haven't heard a word about my date... should I live up to my screen name, be a pest and call 'em?
Jane,
I'm all for the pestering. The person to leave a message for (she responds to the messages pretty quickly but I've never spoken with her) is Shannon Inman @ 281-272-9331 x3405 _________________ DX'd 08/2006, RRMS, currently in the Tovaxin extension study group.
All times are GMT - 6 Hours Goto page Previous1, 2, 3, 4, 5
Page 5 of 5
You cannot post new topics in this forum You cannot reply to topics in this forum You cannot edit your posts in this forum You cannot delete your posts in this forum You cannot vote in polls in this forum
Forum FAQ
Search
Usergroups
Profile
Log in to check your private messages
Log in
Not I--LONG before MS, too! 
