This Is MS Multiple Sclerosis Community: Knowledge & Support

http://www.redorbit.com/news/health/146 ... sis_study/

Has this been posted yet? I see the date line is July 9, 2008.



Opexa Wins Positive Review for Phase IIb Multiple Sclerosis Study

Posted on: Wednesday, 9 July 2008, 06:00 CDT

Opexa Therapeutics has announced that the data safety monitoring board overseeing the on-going Phase IIb clinical study of Tovaxin has recommended that the trial continue unmodified.

This positive recommendation follows a regularly scheduled meeting of the data safety monitoring board (DSMB) in June 2008, and is based upon an evaluation of clinical, magnetic resonance imaging (MRI) and safety data that had been recorded for all patients to date.

Sorry if this is repeat.

Anyone know when they plan to unblind us?

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

My case manager told me it would be when Patient #150 hits Week 52.

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Jane the Pain

I didn't know we we ever going to be unblinded. What does that mean for us exactly? Access to our 11b data? MRI's? drug vs placebo? By the way does anyone know when/if phase 111 begins recruiting.
Lars

We'll at least know if we had placebo or the real gunk. Now about Phase III, I seem to remember that Opexa launched US pretty much after it wrapped up Phase I... but I can't remember if that involved publication or just getting the nod from the FDA to "carry on."

I suspect Phase III-ers will be off and running shortly after we conclude our two years. Probably the beginning of '10?

If our results come back dazzling and Phase III lives up to expectations, I really think the FDA will fast-track Tovaxin before the two-year protocol finishes for "them thar guys."

We have only to read other MS message boards to realize that getting our stuff to market is soooo important.

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Jane the Pain

I hope we get unblinded...

I understood being unblinded meant that we would find out which group we were in (placebo or vaccine) and we would be able to ask questions (and get answers) about our medical history, i.e., MRIs, etc.

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

That would be huge. I'm dying to see what was going on with my MRI's. That's what gets you in to JH and I don't want to pay for one if I'm now SP because they won't take you for Revimmune. It seems I am, but other than a spinal MRI around March, I haven't had a head one since before the trial.

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http://myhopefuljourneyintoactualmsreco ... ogspot.com