Tovaxin Trial Progress

A board to discuss future MS therapies in early stage (Phase I or II) trials.
Lyon
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Post by Lyon »

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gkalman
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Post by gkalman »

Tim,

If you are reading this, you obviously have a lot of fans here. I would not get discouraged just because a few people got offended and may seem offensive. I believe letting others know ones thoughts as they are is the best policy. As a result, some of my best friends are people who have completely opposite views than me. Our debates often raised people's eyebrows, but in the end I respect them for doing and saying what they believe.

Unfortunately, in my case, in the internet boom and bust I have seen quite a share of smooth operators who would talk up penny stocks for a gain. I've learned to be very sensitive to this. You not disclosing a financial interest while getting everyone, including myself, so excited about this new drug you were on, sent shivers down my back when I found out about the financial stake. All of a sudden, it all looked poisoned. Fortunately, you also raised my awareness of Tovaxin, which I continue to believe in. For the first of these I am pissed, for the second, I am grateful.

So, I wouldn't stop doing and saying what you believe just because you rubbed a few people the wrong way. (E.g., for me, that would just get me even more guarded and skeptical if you stopped.)


Everyone,
For my statistical curiosity, does anyone know or have thoughts on chances being positive for MRTCs in this study? (Please?)
I know it doesn't change anything individually. In the end, the result is binary (yes or no). But, it is just me, I like having a feel for the numbers.
sh8un
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Post by sh8un »

gkalman
I have to say that I agree with you. I first read about Tim's story when I was fist diagnosed. It gave me a lot of hope and I eagerly wrote him lots of emails which he never responded to. No, Tim did not have to post his story...but he did...I think that in doing so and being a person who suffers from MS, he took on a responsibility. He took on the responsibility for the emotions of the ppl that read his website. If he were a person who cared about ppl and their feelings, he could have been truthful and ACTUALLY WROTE BACK. What he did is criminal in my mind as well.
As you say, I also believe that we should be able to discuss how we feel. Tim made a mistake, he should know that...he should know how hurtful it was that he never took the time to write back...we all know how MS toys with your emotions. If he could have helped he should have...some ppl may argue that he does not owe anyone anything, I would agree but a as a MS sufferer, I would have not gone about things the way that Tim did. A lot of nice ppl in the world don’t HAVE to do anything either…but they do, and because of them this world is a little better. That is what separates the nice ppl from not so nice.
So now Tim knows how we feel and we can move on. The great thing that happened to me with the whole Tim story, is that I found this site when I searched for Tovaxin. :lol: So I was able stop feeling so alone and I also found some answers as to why Tim was not writing... and I am done complaining.
NN
Lyon
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ewizabeth
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Post by ewizabeth »

gkalman wrote:Everyone,
For my statistical curiosity, does anyone know or have thoughts on chances being positive for MRTCs in this study? (Please?)
I know it doesn't change anything individually. In the end, the result is binary (yes or no). But, it is just me, I like having a feel for the numbers.
I don't know that those details are available or not? I know I saw something along that line somewhere, but I have been reading so much about Tovaxin in so many places. If I run across it again, I'll share it here.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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hmtucker
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Post by hmtucker »

Hello all,

The article that really caught my eye when I was looking at Tovaxin can be found at <http://www.findarticles.com/p/articles/ ... _n15656722>. The most notable part of this report besides a 92% reduction in relapses was that "all patients in the Dose 2 group had a 100% reduction in MRTC counts at the week five follow-up visit."

The "bait" for isolating MRTCs are fragments of 3 different proteins, myelin basic protein (MBP), proteolipid protein (PLP) and myelin oligodendrocyte glycoprotein (MOG). They use 2 distinct fragments from each of these proteins and from the primary literature these fragments were chosen based on studies showing that they were "hyperreactive" parts of the protein sequences. In a nutshell, this means that these particular parts of the protein were very immunogenic, i.e. the immune system really like to make antibodies against them, and a lot of MS folks have MRTCs to these particular fragments.

Are these the only fragments of the proteins that the immune system makes antibodies to? Almost certainly not but MRTCs to these fragments are definitetly a recurring theme in us MS folks. I have not been able to find a number in the literature but the study coordinator here in Lexington said that Opexa expected to have 95% of the people who were screened to test positive for one or more of these 6 sequences.

Take care,
Mike
Lyon
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ewizabeth
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Post by ewizabeth »

Lyon wrote:Thanks Mike,
If you keep talkin' maybe one of these days I just might understand this thing!
Ditto here! :) I understand the concept but when I start to hear the info dealing at the cell level, it goes way over my head... Appreciate your input.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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connieb
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Post by connieb »

Love the 95% figure though! Gives me real hope for the Holiday Season!
Lyon
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connieb
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Post by connieb »

Thanks Lyon, just send the cash-- I am after all on Copaxone and could use the extra income! On a different note, if there is a 100% reduction how do they make more vaccine for you for subsequent infusions? Or am I once again misunderstanding something basic here-- in my next life, I'll try and get a disease that doesn't require a PhD of those who suffer from it!
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CureOrBust
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Post by CureOrBust »

connieb wrote:if there is a 100% reduction how do they make more vaccine for you for subsequent infusions?
Not sure if i read this anywhere, or its just my thoughts. If you have 0 MRTC's then that would imply the Tovaxin made on the last infusion is still effective. ie They could just make more of the last one?
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gkalman
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Post by gkalman »

Well, my wife got results back. Negative.

That's 3 for 3 for the office she tested at.

(1-0.95)^3 = 0.000125

That would fail every hypothesis test I know of. I.e., either 95% is wrong or they are doing something wrong at the office.

Conversely, look at this thread. Three people joined the thread before seeing results (ewizabeth, flipflopper, and I) of these we saw two so far, both negative. If we assume 95%, i.e., 19 out twenty people would test positive, then this occurance is 1 out of 400. I.e., extremely unlikely.

Don't want to discourage anyone, but don't get your hopes up with 95% either.
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hmtucker
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Post by hmtucker »

"On a different note, if there is a 100% reduction how do they make
more vaccine for you for subsequent infusions?"

They only harvest MRTCs from your blood with the one and only 1 pint blood draw. Once they isolate the MRTCs from that and establish a growing culture of them they use that culture to grow more for each subsequent vaccine. That's how they can do vaccinations on a monthly basis rather than at 10 week intervals. When they prepare the each vaccine, they only use part of the total culture that they have growing.

As for the incidence of MRTC negatives, I can only comment that the 95% number is what the coordinator told me. Don't read too much into such a small sample size that is on this thread. Especially in humn populations you need to have pretty big sample sizes before you can make any real statistical statement. Also, if we stay with the 95% number, it's not a 95% chance of positive for each test, it's 95% of the people tested will test positive. Multiple negatives just confirms that you're in the 5% group.

Take care,
Mike
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