Extension study

JanethePain · Post by **JanethePain** » Fri Jan 18, 2008 6:29 am

Got the paperwork yesterday detailing the goodies about the extension study--which begins for me on May 1.

Here's what I've learned so far:

As promised, all guinea pigs get the real gunk. Yippee!

However, Opexa has decided (as of just a few days ago) that they aren't going to disclose until the end of the trial which formula we were on for Part One. I'm not sure what to make of that one. On the one hand, the certainty of getting the vaccine should allay all fears but...

It also means that those patients who didn't respond very well to the real vaccine will have to invest a bit more time into this extension to know if Tovaxin works well enough for them to go the distance.

And in the old paperwork right in front of me, it looks like we're all going to have to endure the same old check for MRTCs and at least 10 weeks for culturing the vaccine.

I haven't gotten through a lot of these many, many pages yet but another piece of good news is that we don't have to do as many MRIs this time around! YESSS!

And, BEST news of all, it's right here in black and white that as long as we make the necessary MRTCs, we guinea pigs will get Tovaxin until it's FDA-approved and we can hit up our insurers for the cost.

So that's the scoop, so far!

Lyon · Post by **Lyon** » Fri Jan 18, 2008 6:40 am

Lars · Post by **Lars** » Fri Jan 18, 2008 1:14 pm

Jane,
Thanks for the update. Lew is going to take exception to the 10 week wait, he has the "69" thing figured out to the hour (sorry Lew, I couldn't resist 1 more jab). I am a little disappointed in the scaling down of the MRI's, it's where I get my long trip naps!
Lars

Loobie · Post by **Loobie** » Fri Jan 18, 2008 3:53 pm

Jabbin' me for 1 day?!? Ha! There's a joke in there somewhere about 69 vs. 70... no wait it's 68 vs. 69, but I digress. That is good news about the MRI's. My coordinator knows I pee like every fifteen minutes in the morning, but he still kept scheduling my MRI's for 9:00am. The first time, I didn't wear a diaper and I had to stop twice and pee! My bladder makes me hate that damn tube. Well he did schedule the last couple for the afternoon finally, so I've got that going for me, which is nice....(gratuitous Caddyshack quote). Man, I've just been in high spirits here lately. I think the NAG is having some minor effects on me because since I've been on it, my mood and my brain fog has been much brighter/clearer. Maybe it's the NAG, maybe it's just the up and down of MS. Who knows?

That deal about not knowing whether we were on the real deal or not does kind of suck from the point of view that Jane brought up. I guess I don't really care what it was if I end up showing improvement going forward, but I guess we'll know it's not working on us for sure now if we slip a bunch. Going up three EDSS points last year was for the birds, so if I go up three more during this part of the trial, I'm calling Chris and see how he's doing on the HiCy. One thing is for sure. I did not know what I was getting in to when I signed up for this trial. I can't say whether or not I'd do it again until I see if this stuff is what I hope it is, but it has been a very stressful year due to the not knowing and progressing so much. Oh well, such is life.

Lyon · Post by **Lyon** » Fri Jan 18, 2008 5:51 pm

TWG · Post by **TWG** » Sat Jan 19, 2008 9:14 am

for additional info on the on the new study see:

http://clinicaltrials.gov/ct2/show/NCT0 ... xin&rank=2

For some reason I don't understand it's considered Phase II. I thought it was going to be Phase III, being we are in Phase IIb. Just returned, 11:30pm MST 1/18/08, and my EDSS is still at 3.5. I entred study at EDSS 3.0.

Opexa site of some interest may be found at:

http://www.pharmafrontiers.net/videoQA.html
Enjoy!

Lyon · Post by **Lyon** » Sat Jan 19, 2008 9:37 am

TWG · Post by **TWG** » Sat Jan 19, 2008 1:53 pm

On that clinical study .gov site our study was listed as phase IIb, so why this is called phase II, may just be a typo. Was surprised that they aren't allowing new guinea pigs to join in the fun.

Lyon · Post by **Lyon** » Sat Jan 19, 2008 2:01 pm

Lars · Post by **Lars** » Sun Jan 20, 2008 7:52 pm

Bob,
The curiosity of how much Opexa spends on this study has always been of interest to me. I keep hearing the phrase "small pharmaceutical company", but if you consider the investment dollars to this point I'm quite sure "small" would be a matter of opinion. It all makes one go back to the question, what will this ultimately cost the public for Opexa to recoup the dollars? The other question that comes to mind is the frequency of injections. If it turns out that Tovaxin is effective with minimal injections, what does that do to the cost of those injections. The money spent on research has to be considered in the final price regardless of injection frequency. Copaxone can justify by saying they supply daily doses, Avonex weekly, etc. etc. If Tovaxin can effectively control this disease in 2 or 3 doses per year (or less), will we ever hear that, or will Opexa be forced to supply more doses, necessary of not, to be a viable company? Really glad I'm on the gravy train for now.
Lars

Lyon · Post by **Lyon** » Sun Jan 20, 2008 8:15 pm

JanethePain · Post by **JanethePain** » Tue Jan 29, 2008 8:36 am

Lyon wrote:Who luvs ya baby? Thanks for the news Jane!

You missed your calling, you should have been a reporter......or a spy! You aren't one of my little sisters are you??

Bob

... well, I sure wanted to start out "reporting" but my university lost the acceditation status for its Journalism School for a couple of years (1974 - 1976, long about the time the printing press became popular).

So I sashayed over to the History Department and plied my evil genius there; hence my screen name.

Geez, I need to get around here more often--you guys have been BUSY!

JanethePain · Post by **JanethePain** » Tue Jan 29, 2008 8:46 am

Lars wrote:Jane, Thanks for the update. Lew is going to take exception to the 10 week wait, he has the "69" thing figured out to the hour (sorry Lew, I couldn't resist 1 more jab).

Lars wrote: I am a little disappointed in the scaling down of the MRI's, it's where I get my long trip naps! Lars

I've chalked up the ease of sneaking MRI naps to the tightness of the Hannibal Lector masks. Prior to this study, when I had MRIs locally, I had the luxury of the open MRI. It was a lot less claustrophobic but came with a really snug mask. I could snooze without worrying about a twitch or a wiggle.

The MRI for this study really tests my phobia management and my "stillness". The mask is really big so there's no "resting on" possibility at all!

Should we demand tight masks for catching MRI naps?

JanethePain · Post by **JanethePain** » Tue Jan 29, 2008 8:56 am

TWG wrote:for additional info on the on the new study see:

http://clinicaltrials.gov/ct2/show/NCT0 ... xin&rank=2

For some reason I don't understand it's considered Phase II. I thought it was going to be Phase III, being we are in Phase IIb. Just returned, 11:30pm MST 1/18/08, and my EDSS is still at 3.5. I entred study at EDSS 3.0.

Opexa site of some interest may be found at:

http://www.pharmafrontiers.net/videoQA.html
Enjoy!

I'm ready for ALL of us to get the real juice and blow these stats away!

It's my understanding that Phase III will be the HUGE one--somewhere between three and five thousand patients enrolled nationwide. It'll probably be ready to roll after our two years of data gets published.

I guess we can expect Tovaxin to hit the market 18 months to two years after Phase III begins. Good thing we'll be getting it SOON!

TWG · Post by **TWG** » Tue Jan 29, 2008 9:13 am

For a description of the definition of what different phases are see:

http://clinicaltrials.gov/ct2/help/phase_desc

To see videos of Q&A's go to:

http://www.pharmafrontierscorp.com/videoQA.html

Click on a question, and get a video. One has the famous Dr. Loftus. "What are the results of the Tovaxin Phase I/II re treatment clinical study?"

Interesting videos. I would recommend watching all of them.