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Old 09-19-2008, 09:10 PM #1
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Default Tovaxin News

http://www.opexatherapeutics.com/

Left hand side of the page there are two current articles about the World Congress on Treatment and Research in MS. The data from the Phase IIb trials was presented.

If you use the pull down menu for investors, you can listen to the webcast. There will be another one on the 22nd.

Quote:
Top-Line Data from Opexa's Phase IIb Tovaxin(R) Study to be Presented at World Congress on Treatment and Research in Multiple Sclerosis
http://www.marketwatch.com/news/story/top-line-data-opexas-phase-iib/story.aspx?guid={B9777FC2-B949-4B47-AF06-C19BC14716BE}&dist=hppr
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Old 09-20-2008, 02:20 AM #2
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Thank you for that FG, and yes I did look.

Good luck with the next phase of the trial.
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Old 09-20-2008, 09:08 AM #3
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Cooool! Thanks!!! Loads of good stuff being released from WCTRIMS.

Can you believe that this is the FIRST time they have all got together?
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Old 09-20-2008, 11:06 AM #4
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It is a good conference.

Some comments about the Tovaxin results. The press is calling the results of the Phase IIb trials disappointing and a failure.

http://www.forbes.com/feeds/ap/2008/...ap5448876.html

Quote:
Opexa Therapeutics Inc. said Friday its lead drug candidate aimed at treating multiple sclerosis failed to meet its main goal in a midstage study, sending shares in a nosedive to an all-time low.
Quote:
Still, Opexa said the results for Tovaxin showed a "positive trend" in reducing the annual relapse rate for multiple sclerosis patients, compared with placebo. Multiple sclerosis is an autoimmune disorder that results in physical and neurological damage.


The company partially blamed the results on a higher number of brain lesions seen in Tovaxin patients before they started treatment, as compared with those on placebo, meaning they were more difficult to treat from the start of the study.
That's just one of the articles, they are all basically the same. I still don't know which group I was in so my comments are purely speculation. Having 2-3 less exacerbations a year is huge for me 1) less steroids; 2) less time away from my job 3) less harm done to my body, etc...

Other favorable factors about Tovaxin is 5 vaccinations a year and virtually NO side effects. There were no adverse reactions.

If you listen to the webcast, if it's still available, the presenters are still positive about the future. They have to be, but there are positives about this trial.

One of the comments that was made was that the majority of the patients in the trial sought out the trial. They were not referred to the trial by their doctors, they heard about it online or from other patients or did their own research and contacted sites that were close to where they lived. The protocol was not an ordinary one in that most patients were accepted with an EDSS score up to 5.5, dx'd up to 10 years, had to have had one relapse in the last year, CIS or RRMS.

I am not trying to justify these results just adding comments from my perspective. Anyone who knows my track record knows that I have not had the usual course of MS (is there such an animal?). I also don't have the heavy lesion load that the majority of the trial patients have. I have a light lesion load but have a lot of exacerbations with no new lesions since dx. Although I have no idea what my MRIs look like since entering the trial in Jan of 2007.

My last vaccine was 9/21/2007. I had one exacerbation end of July 2007, one Dec of 2007, and one April of 2008. The July and April ones were treated with IVSM. The December one was not as it was determined that one was sinus infection induced and would terminate on its own once the sinus infection was cleared up, which it did.

Other than having to change meds for spasticity and increased neuropathic pain, I have been fairly stable. Except for the fatique. Can't seem to get a handle on that. But who can?

Now I am waiting for a positive result in MRTCs blood test so I can continue in the OLETERMS arm of the study which is the open label study. My next blood draw is scheduled for the 24th.

I am open to questions, if I can answer them. Nothing to hide at this point. Other than I don't know which group I was in.
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Old 09-23-2008, 12:43 AM #5
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Cheryl -

I am very sad to hear that the reports are calling the Tovaxin trial a failure. I had high hopes for it.

However, I'm not sure how to "read" your update - do you consider Tovaxin a failure FOR YOU or are you happy with the results. I guess that is really the bottom line.

I also continue to commend you for going through the trial. I wasn't "brave enough" to risk getting a placebo - my MS was just too horrible. But I know that you tried lots of stuff before getting to this point anyhow.

Like everyone else here, I still await a "cure" or at least something more definitive than what is currently available. I still stand by HiCy immensely - but like with all the other treatments, only time will tell. I'm kinda in a grief stage right now b/c I feel like if this fails - I have done everything available and out there. Part of that is reassuring at night when I lay my head down to sleep - and part of it is painful when I awake in the morning just "not knowing" what to expect.


I hate this dumb disease.

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Old 09-23-2008, 11:37 AM #6
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So sorry, Cheryl that the news wasn't so terrific, but, as you say, there may be underlying reasons for that.

I think, it must be working for you and that's whats important. This next trial will most likely be the deciding factor. Let's hope it goes well.

Let us know how your testing goes..
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Old 09-23-2008, 01:50 PM #7
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I am not letting these naysayers get me down. I have an appt with my trial doc tomorrow and will hopefully get some more answers. There are a lot of people who are posting a lot of "negativity" on other sites right now about the report and to be honest, I am sick of it.

You'd think someone had died or there was some deadly side affect attached to this trial drug! Geez...I am tired of people who are not in this trial cramming their drug or their choice down my throat and condemning me for my choice. And HE knows who he is.

As for me, I am having fewer excerbations which means less IVSM and that is a big deal with me.

The jury is still out but I hope to have more information after my appt tomorrow. That's all I know right now.
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Old 09-23-2008, 02:22 PM #8
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I hope it all works out well Cheryl. If this works for some people, that will be great. They need to do a phase III to get more conclusive information don't they?

btw, I appreciate your sacrifice for participating in this trial. I know this wasn't an easy one to be in.
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Old 09-23-2008, 02:34 PM #9
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Quote:
Originally Posted by Av8rgirl View Post

Geez...I am tired of people who are not in this trial cramming their drug or their choice down my throat and condemning me for my choice. And HE knows who he is.
Who is he, who is he? *smack*
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Old 09-23-2008, 03:02 PM #10
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Quote:
Originally Posted by ewizabeth View Post
I hope it all works out well Cheryl. If this works for some people, that will be great. They need to do a phase III to get more conclusive information don't they?

btw, I appreciate your sacrifice for participating in this trial. I know this wasn't an easy one to be in.

From what I understand, the Phase III protocol has been approved. I am not sure when it will begin, I think the company was waiting for funding. I hope to be able to answer that question after my appt tomorrow.

Thanks Wiz, yep it has had it's ups and downs!
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