Currently in Tovaxin IIB Clinical Trial

If it's on your mind and it has to do with multiple sclerosis in any way, post it here.

Postby viper498 » Mon Nov 20, 2006 8:52 am

Connie,

If the Phase II shows real benefit and success, it could be possible. They could fast track the treatment if it really does work (and, heck, they could fast track it even if it doesn't work, because sometimes that happens. Just depends on whether they have a good lobbyist or not, hehe).

Brock
User avatar
viper498
Family Elder
 
Posts: 428
Joined: Sun Oct 09, 2005 3:00 pm
Location: Missouri, USA

Advertisement

Postby Loobie » Mon Nov 20, 2006 10:49 am

I don't imagine I will 'feel' anything either. What I meant to say was whether or not I was feeling improvement. I have had a lot of stuff flare up recently, and the one that I feel like I could get quick improvement on is how my skin almost burns where my clothes touch it.

It feels like I have a cold sore coming on, only it's my entire back and has been this way for a week or so. I can't wear a loose shirt because the constant brushing across of the fabric just sends me into chicken skin mode. I have been combatting it by wearing tight T-shirts under my regular shirts, but I hate that too because I get hot so easy and can't see well. Oh well, that was what I was referring to. I suppose I should be more precise with my details!

I was also wondering about side FX since I was so susceptible to the side FX from Avonex.
User avatar
Loobie
Family Elder
 
Posts: 2196
Joined: Mon Sep 11, 2006 3:00 pm
Location: Dayton, Ohio USA

What I really, really want

Postby notasperfectasyou » Mon Nov 20, 2006 10:57 am

WoW! Tovaxin trial folks. Here at T.I.M.S!!!

I have one rather big question.

Do the participants get any sort of literature or other more detailed info about Tovaxin that us non-participants don't get to see? I'm certain that there are disclosures and legal fine print to read and sign. But, I'm really wondering about more detailed info about how it works and what the existing track record is. I'd love to know what the extended data from the very, very first users is like today. Do folks entering a trial get info that non-participant's can't get?

napay

disclosure: I own 100 shares of OPXA.
User avatar
notasperfectasyou
Family Elder
 
Posts: 774
Joined: Thu Feb 09, 2006 4:00 pm
Location: Northern Virginia

Postby Loobie » Mon Nov 20, 2006 11:12 am

All they explained to me were the characteristics of the drug. I don't think they give the trial participants any additional info. that's not already available to keep placebo effect down as much as possible. They were very thorough in explaining to me the mechanism of the drug, but that's about it.
User avatar
Loobie
Family Elder
 
Posts: 2196
Joined: Mon Sep 11, 2006 3:00 pm
Location: Dayton, Ohio USA

Postby Lizzy » Mon Nov 20, 2006 1:46 pm

i just have the concern that as a personalized medication Tovaxin is obviously going to be very expensive to administer - so for it to make it to the market i would think it would need to have phenomenal results, my fingers are crossed on this one - but i don't know of another "personalized" vaccine out there that has been approved - does anyone else know of one?
User avatar
Lizzy
Getting to Know You...
 
Posts: 16
Joined: Tue Feb 21, 2006 4:00 pm

not to worry - too much

Postby notasperfectasyou » Mon Nov 20, 2006 2:22 pm

Lizzy wrote:i just have the concern that as a personalized medication Tovaxin is obviously going to be very expensive to administer - so for it to make it to the market i would think it would need to have phenomenal results, my fingers are crossed on this one - but i don't know of another "personalized" vaccine out there that has been approved - does anyone else know of one?


The market is going to dictate the price and the wonderful folks at the health insurance store will fight to keep the price "reasonable". It's a therapy and not a cure - meaning you have to keep doing it for the rest of your life and therefore it will need to be competitive with the CRAB's.

On the flip side, I've read some where that Tovaxin has had preliminary results of something like a 90% sucess rate v/s something like 60% for CRAB's. Don't ask me where I read this, might be on a board somewhere. If it's SUPER effective, I could see the price being somewhat higher, but not astronomical. The key will be to have insurance.

From an investment perspective, I'm interested in this company. If this thig works, it will be HUGE. The problem this company has is that they don't have enough money in the bank to fund the completion of this trial. Meaning, they need to raise money by selling more stock and diluting the shares or they need to get bought out by a big pharma like Biogen.

The theory of vacinating against your bad cells is interesting, I do wonder what the long term impact of this might be and I wonder if this permanent disabling of a class of cells has other impacts in the long term that we've not seen yet. Then there's a lot of studies that suggest that B cells, Dendritic cells and other non-T cells are involved in the illness - What's Tovaxin doing about those?

I find this very interesting and I'd love to know more. I hope we get good data out of this study. If I had no insurance and no other way to get treatment, I'd try to get in this study - It seems quite promising. napay
User avatar
notasperfectasyou
Family Elder
 
Posts: 774
Joined: Thu Feb 09, 2006 4:00 pm
Location: Northern Virginia

Postby Lyon » Mon Nov 20, 2006 2:24 pm

00
Last edited by Lyon on Mon Jun 20, 2011 1:44 pm, edited 1 time in total.
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm

Postby dignan » Mon Nov 20, 2006 5:22 pm

Another thought on Connie's question about 2010 approval - sometimes there are combined phase IIB / III trials. I don't know how it works exactly, but I imagine that if they get some interim results that look really good, they might use those results to raise more money and expand the phase IIB trial to a phase III, in which case maybe they could get approval in 2010.
User avatar
dignan
Family Elder
 
Posts: 1608
Joined: Wed Aug 11, 2004 3:00 pm

Postby ewizabeth » Mon Nov 20, 2006 9:37 pm

This is actually a phase IIb trial. If it does do well, it could be faster to the phase III I suppose? To see how it works, you can go to the Opexa Pharmaceuticals website and view the little nifty movies they have. It is pretty well illustrated there.

I have confidence that this one has good potential. Let's hope this is THE one for all of us. I go to the doctor's office to sign the papers on Friday. If I learn anything more, I'll try to pass it along.
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.
User avatar
ewizabeth
Family Elder
 
Posts: 270
Joined: Fri Jun 25, 2004 3:00 pm
Location: Near Chicago

Postby ewizabeth » Mon Nov 20, 2006 9:40 pm

Last time I was tested, my EDSS was 2.0. I'm curious to see what it is this time. I know I have lost function but maybe not as much as I think. I am not as mentally quick as I was, but I try to do brain exercises a lot to battle the cognitive decline.
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.
User avatar
ewizabeth
Family Elder
 
Posts: 270
Joined: Fri Jun 25, 2004 3:00 pm
Location: Near Chicago

2nd

Postby notasperfectasyou » Tue Nov 21, 2006 7:07 am

I have a second question for folks who have been here longer than me.

Did the boards get this interested as Aimspro was headed towards phase III? I'm wanting to get a gauge on the amount of anticipation and hope when compared to Aimspro. Wondering when we were last down this road. Am I too hopeful about Tovaxin? napay
User avatar
notasperfectasyou
Family Elder
 
Posts: 774
Joined: Thu Feb 09, 2006 4:00 pm
Location: Northern Virginia

edss

Postby batpere » Tue Nov 21, 2006 8:29 am

ljm wrote:I'm wondering whether I should ask for a more thorough exam, no one has ever suggested an EDSS level for me, I assumed I wasn't even on the scale. Are you sure, err, that there wasn't an effort to find a higher EDSS than might otherwise have been noted? (I'm assuming neuros were part of clinic selected for trial)

I asked for an estimation of what my EDSS was, and my neuro said only the people in trials get tested and assigned an EDSS score. Didn't quite make sense to me.
batpere
Family Member
 
Posts: 97
Joined: Thu Nov 11, 2004 4:00 pm
Location: dallas

batpere

Postby pvns2005 » Tue Nov 21, 2006 8:52 am

batpere

My Neuro gives me the EDSS tests every time I have an appointment. He did the EDSS tests even before the Tovaxin trial started. It is part of the objective view he gets on how to rate my disability progression. MRI's only tell you so much. I think this test should be done regardless.
pvns2005
Family Member
 
Posts: 85
Joined: Fri Nov 17, 2006 4:00 pm

Re: 2nd

Postby CureOrBust » Wed Nov 22, 2006 12:37 am

notasperfectasyou wrote:Did the boards get this interested as Aimspro was headed towards phase III? I'm wanting to get a gauge on the amount of anticipation and hope when compared to Aimspro.

I didnt even know aimspro made it to phase II? maybe for optic neuritis only.

I thought all the hype on aimspro was because of media reports on personal experiences, where people were getting out of wheel chairs and stuff. Tovaxin hype seems to be based on its reported 92% effective rate in the last trial.
User avatar
CureOrBust
Family Elder
 
Posts: 2909
Joined: Wed Jul 27, 2005 3:00 pm
Location: Sydney, Australia

Postby notasperfectasyou » Wed Nov 22, 2006 6:48 am

We now have 12-month data from our two earlier studies, which indicate that the patients treated had a greater than 90% annualized relapse rate reduction, as compared with their prior history.


ok. I'm a numbers guy. what does this really mean? It sounds like a comparison to me. They are measuring relapse reduction - is that number of exaserbations compared to prior year? Given what this therapy is saying it does, I'd prefer to see something like 90% of patients had NO relapses. The implication is that folks had exaserbations, it's just that they had fewer of them.

My concern is that, the nature of the therapy suggests that it should accomplish a 100 elimination of exaserbations if it works, and this is not the finding. Implying - the targetted T cells might not be the primary source of the illness.

So if someone goes in with 1 exaserbation in the prior year and they exit the trial with 0, this is impressive and amazing to me. If someone enters with 5 and they exit with 4, this is not impressive. Both are measured as part of the 90%, but I think our hopes are that the implications of the former statement is true and not so much the latter one. napay
User avatar
notasperfectasyou
Family Elder
 
Posts: 774
Joined: Thu Feb 09, 2006 4:00 pm
Location: Northern Virginia

PreviousNext

Return to General Discussion

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service