Tovaxin phase II failure

A board to discuss Tcelna as a treatment for Multiple Sclerosis
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TWG
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Post by TWG »

When I was first tested for MRTC I had them, which was a concern, I was hoping they would be zero. They also were able to make my Vaccine in about 6weeks. Was shocked to find out I was on Tovaxin the whole time. Then I remembered what Opexa had stated previously (see below). A guess here would be that it was working initially and then my myelin-reactive T-cell profile changed. That's why I'm leaning to continue in the OLTERMS. This also may be why some think Tovaxin is worthless. I have asked my clinic to see if they can get a hold of my MRTC counts during the trail. Were the vials to test for this? It might explain why initially I thought I was on tovaxin, then latter started to get worse and my thoughts then switched to placebo.


“Approximately three out of four patients re-treated in the second year exhibited a change in their myelin-reactive T-cell profile, which was the basis for producing their individualized T cell vaccine,” said David McWilliams, president and chief executive officer of Opexa. “We believe this new data supports the continuation of our development strategy of individually monitoring patients with our proprietary epitope analysis assay and re-treating them with a patient-specific therapeutic vaccine that associates with their clinical status.”

Any ideas here?
Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
Lyon
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Post by Lyon »

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Last edited by Lyon on Wed Jun 22, 2011 5:25 pm, edited 1 time in total.
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av8rgirl
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Post by av8rgirl »

TWG wrote:When I was first tested for MRTC I had them, which was a concern, I was hoping they would be zero. They also were able to make my Vaccine in about 6weeks. Was shocked to find out I was on Tovaxin the whole time. Then I remembered what Opexa had stated previously (see below). A guess here would be that it was working initially and then my myelin-reactive T-cell profile changed. That's why I'm leaning to continue in the OLTERMS. This also may be why some think Tovaxin is worthless. I have asked my clinic to see if they can get a hold of my MRTC counts during the trail. Were the vials to test for this? It might explain why initially I thought I was on tovaxin, then latter started to get worse and my thoughts then switched to placebo.


“Approximately three out of four patients re-treated in the second year exhibited a change in their myelin-reactive T-cell profile, which was the basis for producing their individualized T cell vaccine,” said David McWilliams, president and chief executive officer of Opexa. “We believe this new data supports the continuation of our development strategy of individually monitoring patients with our proprietary epitope analysis assay and re-treating them with a patient-specific therapeutic vaccine that associates with their clinical status.”

Any ideas here?
That sounds the same as me. I tested positive the first time, very short turnaround for making the vaccine and now I am on blood draw #3 for OLETERMS to test for MRTCs.

When I asked for information about the MRTC during the trial, I was told it was proprietary information and would not be released to the patients. It would, however, be published at some point in time but we would not know which data is ours specifically.

I realize we are test subjects in a clinical trial and possibly releasing this information could compromise the study but it is now open label. How could this information skew our results? There is no more placebo effect? Maybe they think we are going to post information so the "trolls" who are posing as patients on these forums are going to use this information for their benefit...you know the investors or people from other drug companies? That's quite possible.

Anyway, all I know is that I am staying in this trial as long as I can b/c it's the first medication that has worked for me to slow down the relapse rate I have experienced since dx. Going from four to one is better than the statistical data shows ... which to me translates to less money out of pocket for IVSM, less time off work due to relapses, less wear and tear on my body due to the damage caused by the relapse and the steroids, and the list goes on. The only thing I don't know is if my MRI has changed. The only way I guess I will find out is if I go outside the trial and have one done. I've been told I cannot do that, and I follow the rules of the protocol. I've been chastised too many times for changing meds and telling them and not asking first. So I am not going to do something big like having an MRI done ... I think I would be kicked...

Those are my ideas. FWIW....probably not much. My experience with this drug has been very good. Considering the fact that nothing, I mean nothing, else has worked for me, I am very excited and hope that this drug sees it to market. I don't give a rat about those people who bash us for not seeing the light about the therapy that works for them, this has worked for me. Period, end of story. I am happy for them, just as they should be happy for us. We are all in this together, we should all be pulling for each other not fighting over which therapy is the best.
“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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av8rgirl
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Post by av8rgirl »

Ed the investor is complaining about this forum over at Accelerated Cure forum. He doesn't like us!

:(
“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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Last edited by Lyon on Wed Jun 22, 2011 5:26 pm, edited 1 time in total.
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av8rgirl
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Post by av8rgirl »

Lyon wrote:Thanks for the notice.

When the time comes I hope we do ultimately find out what is behind the mixed Tovaxin results we've seen along the way.

My point, and I think most any sensible person's point, is that the information doesn't yet exist to accurately say either that "Tovaxin sucks" or that it's a miracle cure, but any sensible person has to suspect the motives of people who profess to want to see advances for those suffering MS, yet in their ignorance obviously gloat at what they see as the crash and burn of one of the most promising MS therapies?

Proudly I'm among the first to badmouth profits being made from bee venom, goat's blood and berry juice from remote islands and clinics providing "miracles" in third world countries, but when a group of people pursue a therapy for years and years and go the money and efforts to run it through the clinical trial process, there is no joy to be had by sensible people in it's (perceived) failure.

That's why it's not necessary to prove that all these naysayers coming out of the woodwork are nitwits. Their actions alone are the proof.

Bob
Bob

We saw them when Tysabri was pulled from the market and all the investors whined. Never mind all the clinical trial patients who were put in jeopardy and all the data that was put on hold while everything was sorted out. It's not about the investors, it's about the patients and research. Somewhere along the line when something like this happens, the people part gets forgotten. WE EXIST.

Same thing here except that the investment crowd is just whining and wondering why we are risking our health for this drug that is a failure. Failure? That is what I just don't understand, and maybe never will. MS is such a difficult disease to dx that it's also a difficult one to find a "one size fits all" medication to treat. Those who don't understand that will never understand the complexities of these trials. What works for one doesn't always work for another.

A failed medication is one that doesn't work at all or causes harm to the point that the FDA steps in and pulls it or shuts down the trial or the pharma stops it. Has that happened? No.

I think, IMHO, that when a cause is found for this disease, then maybe a cure can be found. Until that time, the researchers must continue to look for medications to treat. Period.
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
patrickm
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Post by patrickm »

Ant148 wrote: drug sucks, stock in the toilet, end of tovaxin story. oh well, shit happens...

ps Mike don't put me in your group of "flaming people who have crawled out of the shadows who seem pretty pissed off and have told all of us who are participants in this study that we are fools, that we've been scammed, that we should perform beastiality on our horses". i was in the trial to the hilt, ok? i got the actual tovaxin and it didn't help but actually hurt me. i'm not claiming anyone in the trial is a fool or has been scammed. the horse thing was in response to an asshole that attacked me unprovoked. any more explanation needed?
I attacked you unprovoked? I didn't attack you. I pointed out that you had violated the terms of the trial, lied, and then rationalized your behavior. And when your behavior was called out, behavior that also jeopardizes everyone in the trial and those who haven't yet seen Tovaxin, you responded by equivocating and grade school name calling.

So now that you are out of the trial, I assume you've finally been man enough to tell your trial coordinator in depth about your violation of protocol so they can pull your statistics from the study? You were either 1/50 or 1/100, and if 18 people dropped out, then you were 1/42 or 1/88. Those are not insignificant statistics. Man up, Anonymous Third Grade Name Caller. Own up.

And to whoever said, "why would anybody want to take a drug where you couldn't take anything else?" Well, there are plenty of those in the real world. Think about it. But that is an irrelevant question in a clinical trial. In any early stage clinical trial for a new treatment, and this is one of them, the object is to isolate the treatment against the problem to be able to judge results. Anything else you take that skews that data is harmful to the trial, which the point of the whole exercise.

It may be that LDN and Tovaxin end up being the dream combination, I doubt it but maybe, but you don't START clinical trials on an unproven drug by combining them with another drug, and certainly not another unproven drug. The first real LDN study only recently started, and far too late on that I think. I'm very interested to see what it turns up, but if you go into the LDN study also on Tovaxin and Rebif, how will anybody know what's working, not working, or poisoning you? Isolate and study.
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mommasan
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Post by mommasan »

My head is spinning right now from this discussion. Not difficult to happen after 22+ years of MS and as as many lesions in my brain, as functioning brain. But, before I lose my train of thought...I think everyone has a valid point. I tend to take people at their word (and get into trouble doing so). It pains me to see people being attacked without fairly certain justification. WE ALL WANT TO SEE THIS DAMNED DISEASE ERASED.

1. I am thrilled that Tovaxin has worked for so many;
2. We all want a cure and this was never promised to be a cure;
3. The difference in population variance COULD account for the "perceived" failure;
4. Tovaxin, as it was truly meant to be developed and function immunologically has never gone thru a trial and can't until the epitome shifts are adjusted for to create constantly changing, individually tailored vaccines.

I think there is more going on with the lack of success for some, but until a real trial takes place we will never be able to place it wholly in either the failure or success category. This is just my fairly uneducated 2 cents.
Sandy
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mommasan
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Post by mommasan »

Sorry Bob,
Just looked back at your post and realized my post was completely redundant. I take back my 2 cents. You said it all much more eloquently!! Damn my swiss-cheese brain.

Sandy
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