Opexa Announces Top-Line Results from Phase IIb Trial

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby CureOrBust » Fri Sep 19, 2008 5:18 pm

yes, the news is disappointing. Big time.

But the concept is far from dead. There are still the results from the sheeba trial (or whatever its called) as well.

I do not consider myself an "up" person, but, hopefully the whole medical profession gains valuable knowledge from these results.
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Postby cheerleader » Fri Sep 19, 2008 5:24 pm

I'm really sorry for everybody involved and affected. Bob, your wife is stable, and she's been doing well during the trial, right? No reason to expect anything else. Stay positive. My heart goes out to Lew and anyone else who progressed during the trial. This paragraph really stuck out.....


"It is important to note that initial review of data revealed that patients in the study’s Tovaxin arm, on average had a substantially greater number of MRI brain lesions and corresponding lesion volumes at baseline compared to the average number of MRI brain lesions and lesion volumes per patient in the placebo group. The company believes that this unexpected imbalance may have contributed to the study not achieving its primary and secondary endpoints as patients in the Tovaxin arm began the study with greater disease burden and increased severity of disease."

Seems to me the docs gave the real thing to their patients who had more lesions and damage, while giving the placebo to those less affected. Sounds like an excuse. Wow. Really shocked by this-
AC
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby sandonpoint » Fri Sep 19, 2008 5:50 pm

This is so dissapointing

Just cements the theory that T-Cells are only minimally involved in MS and makes me hope that Campath and Revimunne come to market quickly.

Sandon
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Postby av8rgirl » Fri Sep 19, 2008 6:44 pm

My perspective - as Dr. Fox said, MS is a mysterious disease and unpredictable. I can certainly attest to that.

The results overall may be disappointing but there were some good points made during the presentation.
Last edited by av8rgirl on Wed Sep 24, 2008 7:43 am, edited 1 time in total.
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Postby Loobie » Fri Sep 19, 2008 6:52 pm

They could've just come to my house! I'm just glad to feel "MS normal". That is a totally F'ed up statement, but I mean it in the context of hoping other treatment that work for others will work for me. I was beginning to think that my case was special, ie, won't respond to anything. Hell, I know I've been progressing, this just helps me process a little better. Rush or JH here I come. First some 'roids, then I'm outta here.
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Postby av8rgirl » Fri Sep 19, 2008 6:57 pm

Loobie wrote:They could've just come to my house! I'm just glad to feel "MS normal". That is a totally F'ed up statement, but I mean it in the context of hoping other treatment that work for others will work for me. I was beginning to think that my case was special, ie, won't respond to anything. Hell, I know I've been progressing, this just helps me process a little better. Rush or JH here I come. First some 'roids, then I'm outta here.


Good luck with the 'roids!

What's "MS Normal??" WTF?
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Postby Loobie » Fri Sep 19, 2008 7:28 pm

Like I said, "That is a totally F'ed up statement, but I mean it in the context of hoping other treatment that work for others will work for me." "MS normal" in the context of the quoted phrase from the last post. What I really mean is that I was thinking that the reason Tovaxin did absolutely nothing for me could be that my personal case of MS responds to nothing and that the norm. would be something might work a bit. Probably a bad choice of phrase since there's nothing normal about MS.
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Postby av8rgirl » Fri Sep 19, 2008 7:42 pm

Loobie wrote:Like I said, "That is a totally F'ed up statement, but I mean it in the context of hoping other treatment that work for others will work for me." "MS normal" in the context of the quoted phrase from the last post. What I really mean is that I was thinking that the reason Tovaxin did absolutely nothing for me could be that my personal case of MS responds to nothing and that the norm. would be something might work a bit. Probably a bad choice of phrase since there's nothing normal about MS.


We are on the same page here! Nothing normal about my MS either...I've not responded to anything and who knows, maybe I have been on nothing and I am just in a "slow down" phase. Who knows. That's why I am so anxious to see the results of the past year. Being unblinded is going to be very interesting for me.

There is nothing "normal" about MS. You cannot treat everyone the same. I honestly believe that's why most docs get themselves into trouble with their patients, they try to treat them all the same. Can't do that.

I am still suffering from a bad case of jet lag...so I'd better stop now. I don't think i am make any sense!
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Postby notasperfectasyou » Fri Sep 19, 2008 9:13 pm

cheerleader wrote:Sounds like an excuse. Wow. Really shocked by this


Excuse?

Sounds like an Arthur Andersen level of professional conduct. How can scientists fail to set up a multi-million dollar study properly from the beginning?

Makes me feel like they knew there were limitations and they deliberately set it up this way to provide deniability later. I know that sounds like an evil conspiracy, but it's just how this makes me feel today.

I'll likely feel better tomorrow. But, it just seems suspicious to me. How did they get 90% in the last trial? Something is not logical here. Something is missing. It's just a natural tendency of the "auditor" in me to suspect foul play first. I don't mean to be poking fingers or putting them down for having a less than acceptable result.

Someone still believes in Opexa, the shares are up in friday night after hours trading. It's a tiny positive, but it's a positive nevertheless. Ken
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Postby flipflopper » Fri Sep 19, 2008 10:30 pm

notasperfectasyou wrote:Makes me feel like they knew there were limitations and they deliberately set it up this way to provide deniability later.




The same thought crossed my mind when I read the article earlier today. I have other things to write about this trial but I don’t have time to do it tonight.
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Postby rainer » Sat Sep 20, 2008 3:03 am

I wonder how much of the placebo arm dropped out of the study due to lack of results. That'd obviously skew the stats.

Very disappointing.
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Postby Loobie » Sat Sep 20, 2008 4:23 am

I don't know. If many were like me they stayed in despite not feeling like it because other things have not worked. I would never have dropped out of the trial to go back on a CRAB and I'm probably not alone there. I haven't tried Copaxone, but I guess I'm kind of guilty of putting all the CRAB's together since they are always talked about as one.
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Postby hmtucker » Sat Sep 20, 2008 5:19 am

Howdy all,

I think we all need to sit back and digest the data that Opexa presented here as well as the upcoming more completely analyzed data that will be released in the coming months. Please realize that although marketing your data is part of the game, this is a scientific setting not a newspaper article and all of the data will be put on the table for all to see and analyze. Also realize that in these 15 minute presentations at a scientific meeting the general setup is to spend 3 to 5 minutes introducing your project and providing background information, closer 5 minutes for a new and complex treatment paradigm, 5 to 7 minutes presenting the current data and then 5 minutes for questions. So, it is just impossible to present all of the data in a fully explained version in this setting. Let's wait until all of the data are on the table before we come up with conspiracy theories.

The biggest problem with the initial data are that the placebo arm ARR was lower than expected and the Tovaxin arm ARR was higher than their previous studies (consisting of only 22 people) at 0.339, 0.214 and 0.1 respectively. An encouraging statement is that for the people who had >1 ARR, Tovaxin provided a 55% reduction in ARR for that group compared to what I assume is a similar group in the placebo arm. The CRABS would love to have those numbers. They also state that the Tovaxin group had a larger lesion volume than the placebo group which possibly indicates that the Tovaxin arm was more affected by MS than the placebo arm at the outset of the study. So, if the Tovaxin arm and placebo arm were not truly similar groups at the outset of the study then comparisons between those groups are not necessarily valid. If the Tovaxin arm was indeed more affected than the placebo arm then we should be more excited about the Tovaxin ARR rates. An important bit of information will be the percent change of the lesion volume in the Tovaxin arm compared to the placebo arm. As someone else pointed out, the percent changes in EDSS will be interesting to see. The role that epitope shift played in the efficacy of the Tovaxin treated people was also not mentioned. Also, in any treatment there is a group that responds very well and a group that doesn't respond well at all. How does the size of these groups shake out and how did these groups do? These are data that will help to more fully evaluate the true efficacy and clinical relevance of Tovaxin.

Assuming that Opexa stays in the game I know that for each of us personally, staying with Tovaxin will be based on how we are doing in the extension study. I for one am looking forward to continuing the extension study and hope that that possibility will continue to be available to me.

Take care,
Mike
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Postby Lyon » Sat Sep 20, 2008 6:54 am

..
Last edited by Lyon on Wed Jun 22, 2011 6:38 pm, edited 1 time in total.
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Postby patrickm » Sat Sep 20, 2008 7:10 am

Well after a good night's sleep, a long exhale, and more tequila than I've had in one sitting in 3 years, I can safely say that I'm just as bummed and PO'd as I was yesterday afternoon.

Also, I called the neuro office yesterday and told them what had transpired on the report, and asked for my doc to call me back after reading it so he could maybe talk me off the ledge. My nurse called and asked me to explain and then said, "Oh, you need to talk to the doctor." Uh, yeah. And he never called.

Wish I had some sunshine but I just can't f'ing muster it. So, happy Saturday everybody.

Maybe at least the Cubs won't give up 12 runs in 6 innings today.

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