Opexa Announces Top-Line Results from Phase IIb Trial

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby L » Tue Sep 23, 2008 9:59 am

I'd join the people here who see .2 relapses a year as impressive. The results are good! It was the placebo group being so lucky and staying so healthy that's to blame...
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Postby Lyon » Tue Sep 23, 2008 1:51 pm

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neurovax

Postby notasperfectasyou » Tue Sep 23, 2008 2:39 pm

I did a bit of googling on neurovax (the other vaccine method that was being developed by Orchestra - different approach). Looks like it is near it's end now. I don't know much about neurovax, except that it was once believed to be "THE ANSWER". I remain hopeful that there is some substance to Tovaxin. Ken
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Re: neurovax

Postby Lyon » Tue Sep 23, 2008 5:27 pm

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Postby dignan » Tue Sep 23, 2008 6:39 pm

Ken, I recently did the same as you on Neurovax and came to the same conclusion (removed it from the pipeline list). Orchestra/Neurovax were somehow connected with Oregon / Dennis Bourdette I think, but they were doing the trial in Eastern Europe, I assume to save money.
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Postby Cyclops » Wed Sep 24, 2008 12:55 am

As far as I'm aware, the NeuroVax trial was halted as Orchestra ran out of money.

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Postby Lars » Wed Sep 24, 2008 6:05 pm

Maybe I should shut up but I am going to give a brief summation of my phone conversation today with my Clinical staff/personal Neurologist. They were in Montreal and have spoken at length with the Opexa staff. Here's what I gather, it was not necessarily a random draw for vaccine, it appears the "worst" cases were selected. The only reason I can come up with is a black jack term "doubling down". Stunning results with the worst group makes for a stunning future. Backfire. Their opinion is that Tovaxin still has a future with mildly affected patients but NOT with advanced cases. I fall into the later group and appreciate that they have been honest with me about finding a new course. Would it be to late to ask you all to keep this between us?
Peace,
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Postby hmtucker » Thu Sep 25, 2008 8:12 am

Lars wrote:Stunning results with the worst group makes for a stunning future. Backfire. Their opinion is that Tovaxin still has a future with mildly affected patients but NOT with advanced cases.


Lars,

That is an interesting interpretation and one that could easily be flipped 180° with the interpretation that Tovaxin working great for more affected cases. A 0.2 ARR for more seriously affected cases should be considered very good especially compared to other approved treatments. As an aside, many thought that the Tysabri results were fishy because many thought that the Tysabri arm was much less affected than the placebo arm.

It seems that the general problem with reaction to the top line results was that the placebo group was too low compared to the Tovaxin group giving the impression that Tovaxin didn't help out all that much. However if the two groups were indeed very different, non-randomized populations then direct comparisons are statistically invalid and meaningless.

Mike
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