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You all (trial participants) are following this more closely than I am, so I don't know if this is old news...



Opexa Therapeutics Gives Update on Phase IIb Trial of Tovaxin(R) for Treatment of Multiple Sclerosis

Sep 11 2007, Business Wire - Opexa Therapeutics, a company involved in the development and commercialization of cell therapies, today provided an update on its 150-patient Phase IIb safety and efficacy study (TERMS) of Tovaxin in multiple sclerosis. The trial design is a U.S. multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis.

Trial Highlights:

-- All 150 patients have received their first vaccine dose in the five dose vaccine series.

-- More than 60% of the total 750 vaccine doses of the study have been delivered.

-- Individualized Tovaxin formulations for all 150 patients have been manufactured with more than 95% of them being unique myelin epitope profiles as identified by Opexa's Epitope Analysis Assay. The variety among the formulations highlights the diversity of myelin epitopes contributing to the disease and supports the individualized therapy approach of Opexa's Tovaxin therapy.

-- The Data Safety Monitoring Board has met three times and reported no safety issues and recommends continuing the trial as planned.

David McWilliams, president and chief executive officer of Opexa Therapeutics, stated, "I am pleased by the steady progress of the trial and recommendation of the Data Safety Monitoring Board and we now look forward to reporting 52-week results in the second half of 2008." McWilliams continued, "We are encouraged that the diverse myelin peptide reactive profile of each patient that we have identified thus far in the study brings us closer to realizing the promise of individual therapy in general, and specifically supports our individualized therapy approach to the treatment of multiple sclerosis."

http://www.genengnews.com/news/bnitem.a ... e=22892993

Thanks dignan, I hadn't seen it before.
Bob

Thanks Dignan,
Now, who can explain Myelin Epitope to me. I don't have a clue but it sounds really good.
Lars

Lars wrote:Now, who can explain Myelin Epitope to me. I don't have a clue but it sounds really good.

An epitope is usually described as the region of an antigen (some foreign protein) that is recognized by an antibody. In the case of Tovaxin, the use of the word epitope likely refers to the region of the myelin proteins which are recognized by the t-cells.

NHE

The trial was supposed to be 52 weeks.

I'm wondering how long it takes to get results, since the trial should be over. napay

Hi NAPAY,

Actually I think the trial might have gotten a later start than originally predicted. My wife was the first person to register and begin treatment in Michigan and she hasn't had her last treatment yet.

Additionally, I'm pretty sure that the situation is that the year runs from the date of first treatment and, although there were people nationwide who were treated my wife was, there are also lots of people who received first treatment after she did.

In my wife's case, the year should be up on April 25, 2008, but I don't know what the date of the first treatment for the last person was (a year from which would signal the end of that phase of the study).

Bob

Thanks Bob!

I sure hope this works out for her. I've been interested in Tovaxin for a good while.

Are you still up for me drafting you for president this coming election?

Ken

Hi Ken,

Thanks for the kind wishes! I forgot that I was going to look my wife's schedule up and let you know where she stands in the treatments.

It really is hard to guess what is going on when you're in one of these double blind placebo clinical trials. Especially when the trial calls for mild MS participants and especially when the real treatment is so innocuous. All I can say with certainty is that my wife was diagnosed almost two years ago and has experienced no progression and no further relapses.

Does that mean that she's on the "real thing" and that it works? Or does that mean that her MS is VERY mild? I've considered it a lot, I've dwelled on it and I have no way of knowing what the real answer is.

If there is any "new" news in this situation, it involves some old news which I recently was reminded of. Before my wife started treatment, the trial people called here and were concerned whether or not my wife was alright because her baseline MRI for the trial showed a new enhancing lesion. If they hadn't told her, she wouldn't have known, but I think that's why her EDSS was 3.5 and I think that might be why it dropped to 1.0 after one treatment.

On one hand the above knowledge might make Tovaxin's effect (lowering of EDSS....IF she is on the "real thing") seem a little less dramatic, but on the other hand it might show that, without intervention, her MS is much more progressive than it seems. To my knowledge, she's had no more MRI action since she's been in the trial and my wife and I have had no reason to think that ANYTHING MS related is going on in her system.

As is always the case, time will be the ultimate judge.

Before Bush became President I was convinced that I wasn't smart enough for the job. Now it seems I'm overqualified!

I think I'd rather NOT be Bush's replacement because that poor dear is going to be handed some HUGE messes to straighten up!

Sadly, yet again, there are no stand outs among the people who seek to be in the next Presidential election.

I have a hard time believing that the US population has expanded 10 fold, yet there isn't a Washington, Jefferson or Lincoln in the bunch and only Clintons and Bush's?
Bob

At least Clinton will make good juicy news, and it won't be all war related!

Oh yeah, can we say Stem Cells baby?

chrishasms wrote:At least Clinton will make good juicy news, and it won't be all war related!

NO, DON'T TELL ME......Hillary also enjoys cigars?
Bob

With a face like that she either just tasted a cigar from the Monica humidor or.....I'll just let that one go right there.

Yup, we're on the same wavelength......low though it may be!
Bob

Bob,
Sounds like you're knockin' on wood. Good Luck with the trial.

It's a sad state of affairs when you honestly don't want to encourage your kids to grow up to be president. Something happened in the country and I honestly feel it preceded Bush and Clinton.
Ken

I'm not Bob but my kids can be president but I refuse to raise them that way. Plus, there is a chance they could get hooked on drugs and become a Republican.

I already got MS, I don't need any other issues.

dignan wrote:You all (trial participants) are following this more closely than I am, so I don't know if this is old news...

Old or not, it's still nice when someone nice posts nice stuff! I thank ya.