This Is MS Multiple Sclerosis Community: Knowledge & Support

Okay, let's get on with it already. I've had some lasting damage from my last flare and I'm ready for this sort of thing to be DONE.

http://www.opexatherapeutics.com/?page=release&section=news&article=041511

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Jane the Pain

I have been waiting forever for this to become available to the public. It is a great concept.

I am all for this company and its "drug." It is a very simple idea. Superior safety profile, and it seems very effective.

Thanks for posting! It makes me happy to see this therapy moving along.

And yesterday's update!

http://www.opexatherapeutics.com/?page=release&section=news&article=050611

Maybe we'll all be back on board in time for the first hard frost.

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Jane the Pain

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Well, let's just hope things start picking up SOON!

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Jane the Pain

I'm hoping that's just "understood" because for Opexa to have reliable post-trial data, they'll need as much participation as possible from the lab rats in Phases I and II and well as the new III.


That would push Tovaxin into the "cure" category rather than "treatment." It was my understanding that during future trials and once the gunk comes to market, we'll be schlepping hither and yon for our five treatments annually.


I know what you mean! I'm still learning to deal with the "numb thumb" and think this will be permanent deficit. So I'm not warm and fuzzy about "other stuff" and really getting seriously impatient about the next step. Grrr.

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Jane the Pain

I see that Opexa has been approved to start Phase III in January by the FDA. When the Phase IIB open label phase was shut down, I was in the process of being tested for MRTCs and they couldn't find any to continue me onto that phase.

I've seen my neuro on a regular basis since the shut down, have had a couple of MRIs [no new lesions] but continue to be symptomatic. I've not had a 'major' exacerbation but I do have exacerbations on a regular basis and have been treated with IVSM. I am currently on monthly pulse steroids which has been my only tx since the shut down of Phase IIB.

Any idea what the entry will be for us "waiting" in the wings former Tovaxin Lab Rats will be for this next phase?

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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

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I guess all we can do is hope they see it that way - that we are assets and not liabilities! Considering the fact that I - who was a huge success story - have never heard from anyone since the trial was shutdown, I am highly skeptical of anything at this point! I am just hopeful, I suppose, that they will at least allow me the opportunity to be tested for re-entry!

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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

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They did get FDA approval for the Phase III trial. It was published the other day.

I am not following your logical ... why would we have to get new MRIs? We've already been diagnosed. We are a known quantity. We have been through the Phase IIb trial. And if we didn't go on any other tx since the shutdown, we should be good candidates for the Phase III trial.

However, if they were to start with a whole new batch of unknown MS patients, it would cost them a whole bunch of money.

whatever...

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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

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You could be absolutely right about this, without a doubt.

But if we, the lab rats, weren't going to qualify for Phase III, you would think there would have been clear communication on that point with one of us during these last years and e-mails. Or even official notices coming in snail mail. It would have been a no-brainer to have written, "We're glad you have lots of nice things to say about Tovaxin but the truth of the matter is that Phase III will be limited to NEW patients."

And to the best of my knowledge, in the two mails I've had and the one (?) Cheryl got, this was never stated directly or indirectly or even broadly hinted at.

But, of course, it could very well be the case.

Cheryl, when you were involved with all those Tysabri/Antegren trials, can you remember if the final phase compromised newbies only... or the sum-total of Tysabri/Antegren patients during the whole kit and kaboodle?

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Jane the Pain

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