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.

http://www.marketwatch.com/news/story/top-line-data-opexas-phase-iib/story.aspx?guid={B9777FC2-B949-4B47-AF06-C19BC14716BE}&dist=hppr

Thank you for that FG, and yes I did look.

Good luck with the next phase of the trial.:hug:

Cooool! Thanks!!! Loads of good stuff being released from WCTRIMS.

Can you believe that this is the FIRST time they have all got together?:rolleyes:

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

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.

Cheryl -

I am very sad to hear that the reports are calling the Tovaxin trial a failure. :hissyfit::Sob: 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.

~Keri

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..:hug:

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. :mad:

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. :mad:

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

The jury is still out but I hope to have more information after my appt tomorrow. That's all I know right now. ;)

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. :hug:

Who is he, who is he? *smack*:p

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! ;)

Thanks for the article and update, Cheryl.

I've read some of the conversations going on . . . but I haven't personally researched the results of the trial, or other factors, enough to know what it all might mean yet.

From what I know, I agree with the points you listed in your posting (I don't think you are being unobjective), and I think there are still several other factors to consider too.

Did you find out if you were on the real thing then, during the trial?

I had high hopes for Tovaxin, so I will have to get down to understanding this new information, I guess. :o

Cherie

I won't have any answers until after my appt tomorrow. I am still thinking positive about everything.

I also wanted to wish you all the best with your appointment tomorrow FG. I'll be thinking of you. :hug:

I was a guinea pig many years ago (late 1970's) when Interferons were first being trialled, so I have some idea of what you're going through for the ultimate benefit for us all.

What I don't understand is how anyone could be negative about what you're doing. Don't people realise that without the likes of yourself, myself and many others like us involved in these trials, there wouldn't have any medications for MSers to choose from? There would be no advances in those we already have.

Although it's unlikely that I'll be taking Tovaxin when the trials are finished, I still want to thank you for your part in a trial that stands to benefit many thousands of MSers around the world.

Good luck, Cheryl
 

Cheryl -

My thoughts will be with you on Wednesday - and hope that the appointment exceed all of our positive thoughts heading your way :)

I am curious to know if they will disclose to you if you were on placebo or real drug....and will they give you the MRI results? Oy, that would kill me - just not knowing!! I wanna see my brain!

I also agree - less IVSM = VERY good! Can't complain about that.

Keep us posted!!

~Keri

I want to know as well Keri! I am hoping to get SOME answers today! But I just don't know what I will find out today. But I will let you all know. One poster said that he/she was already told but I have little faith in anything that poster has said...

I agree, less IVSM = very good! I have had a lot of IVSM since I've been diagnosed. Even ONE less relapse a year is good for me.

I listened to the conference call on the Opexa site last night and found a lot of the information very good. They focused on the annualized relapse rate of the Tovaxin group with the higher lesion load vs the annualized relapse rate in the place placebo group with a much lighter lesion load and the stats were put in a better perspective. The Tovaxin group had a might higher disability rate to overcome and it just happened to be coincidence. So, I am focusing on that and not some hocus pocus that these investors/non-trial participants are saying. These are the people I want (maybe others too) want to shoot. But that's me.

I know how *I* am doing so we shall see what happens. Moving forward, thinking positive.

Thanks for all the support everyone. It's been a rough year and a half.

We have not been unblinded yet by the Study. All the data has not been correlated to the point where each patient can be identified. As soon as that happens, we will be contacted and told as much information as is available.

I got enough questions answered today that I am satisfied with the presentation at World Congress regarding the Phase IIb trial results and hopefully there will be funding forthcoming to continue the rest of the trials.

I am to see my opthamologist for an eye exam, again, and see what he has to say.

Now I wait for the results of the blood draw today, should be 2 weeks or less.

Good Luck, Cheryl..:hug:

Thanks Sally. ;)

Cheryl, you couldn't find out about your own data today? Darn! I'll keep my fingers crossed for you and the blood draw. :hug:

No, it's not available to anyone yet, including the trial site coordinators. It has not been released. As soon as it is, we will all be notified!

:D

LOL @ wanting to shoot the naysayers!
I listened to the conference call too, and I found a lot of positives in the data. Let's hope you get the news soon and that you make those MRTCs this time!

From what I understand so far about the trial, the results were viewed as not nearly as positive (as some people might have expected) in terms of relapse rates. They "expected" the Placebo arm to have annual relapse rates somewhere around .8 (similar to the initial CRAB trials):

... however the placebo group in this trial had an annualized relapse rate of only .334. ie. Even though Tovaxin still proved to reduce relapse rates to .21 vs .334 for placebo (a reduction of about 50% over Placebo) . . . because they were "expecting" a .8 Placebo rate (similar to the CRABs), it made this treatment "appear" not as effective as it probably is.

I think they should at least be able to take an "average" from the other trials, as obviously something went wrong here.

From what I gathered of the conference call, they think this happened because although everyone from both arms had a similar relapse history . . . they inadvertantly put the people with the most disease activity (number of active lesions at the start of the trial) in the treatment arm of the trial, and the one's with the least in the Placebo arm.

Seems like perhaps a silly mistake to make, but if it's true (or they had instead mistakingly put the "active disease participants" in the placebo arm), we certainly would have "appeared" to get entirely different results.

(Not that I think relapse rates are the end-all, be-all for evaluating the efficacy of these drugs anyway, but it is one of the current secondary measures . . . :rolleyes:)

Cherie

I know who HE is, Cheryl...:D I went over there and read a bit and laughed my head off. Don't let any big mouth know it all, know nothings, P you O. Certain tranparency and stupidity loom large, in certain places, by certain people..

Good for you for keeping your cool...you're a better person for it.:hug:

The bottom line is that the trial was too small.

Ok....what?

I have to go back and read this again.

Give me time here.....

I've heard that many of the trial patients have been unblinded today. I never got a call....:(

Cherie, have you heard from Sweetyhide???

I've "seen" her around, but she's in a very bad way at the moment and not talking the last few days. :(

Cherie

I am sorry to hear that. I know there is some "bickering" at the other forum and I hope that isn't adding to her stress. It's stupid what's going on.

I've not heard from my site coordinator, I guess the unblinding results are slow moving West :(

Ohio, Kentucky and Alabama people have checked in that they've heard. Oh well, whatever! :rolleyes:

Amen to the stupid stuff!
But my issues are un-ms-related - for a change!

Cheryl I called my coordinator and told her to find out. She did and called me back. I was on the placebo. Yes I did remarkably well - overall.
Glad of that.

edited to add:
Just got a call from my coordinator and they dont have to reschedule me (because of storm).
My vaccine is made and I get it tomorrow!

I am sticking to Tovaxin as long as they will have me.
My faith in my decision hasn't changed.

Good luck to you too!

I called today and left an email but I never heard anything back.

I am glad you are sticking with the trial. I will too, if I get back in! I am waiting for the results of the last MRTC blood draw.

http://www.redorbit.com/news/health/...lerosis_study/

Here's another news report.