This Is MS Multiple Sclerosis Community: Knowledge & Support

I, too, feel that it will be drawn at the 52 week point. As I stated, there was talk about getting it before then, but that's as far as it went as far as I can tell since I have not heard from them and only have an appt. for the 27th of Nov. (which will be 52 weeks).

I'm sure you're right Tim, but it takes all the fun out of harrassing someone if I'm restricted only to the truth
Bob

Tim,


How many times per year do you go to Houston for your extension trial? I live far away from my trial site and I would be very curious to know approximately how many visits per year will be required in the extension trial (for the phase IIb trial)



Even last week, when I asked the trial coordinator questions about the extension phase, I was told something very similar to what Mike was told (that the final protocol for the extension study was not completed yet)

Hi Flipflopper,

I seem to average about 6 trips per year. I am under a different protocol than the IIb trial. I am just finishing the first leg of my extension study, and I expect that there will be a new protocol to sign.

I would expect that you will need to make the same number of trips that you made during the first year, except for the trips you made to qualify for the study. My guess would be a trip to draw the bag of blood and close you out of the first part of the study. This would be followed by the series of 5 treatments, and would end with a week 52 bag of blood. This cycle would repeat until Tovaxin is approved.

The protocol is always finished just in time to start the next phase of the study. This allows the scientists every opportunity to adjust the protocol to reflect what they have learned.

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Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

Thanks Tim!

This may be long, but it will give the order of how things happen. And steroid stuff as well. Me and the neurologist are blinded but we both think I am on the placebo due to the two relapses, I never had a relapse the literaly took me off my feet. Started with EDSS of 3.0 I now 3.5. my relapses shot my EDSS to 5.0 before the steroids, hope this isn't to long winded, hope it answers some questions an gives a time line of sorts

Tovaxin Stuff

• Wed 9/13/2006 Last Rebif injection!
• Fri 9/15/06 Signed consent forms at Dr. for Tovaxin trial.
• Tues 10/31/2006 Vial blood draw for MRTC’s --Negative.
• Fri 12/8/2006 2nd Vial blood draw for MRTC’s. --Positive EDSS 3.0.
• Wed 1/17/2007 Blood draw to make vaccine. MRI.
• 3/2/2007 started a bad relapse.
• 3/8/07 Saw Dr. about bad relapse.
• 3/8-3/10 2007 received 3 day course of IV Solu-Medrol, 1gram per day without oral taper. 30 days until re-evaluation to see if this made me stable.
• Mon 3/12/2007 received the useless MRI.
• Fri 3/16/2007 Saw Dr. . EDSS 5.0.
• Wed 3/28/2007 10 weeks since blood draw to make vaccine.
• Mon 4/9/2007 30 day mark since last infusion.
• Tues 4/10/07 Dr. found me stable. EDSS back to 3.0. Vaccine ordered from Opexa. Was told I will get MRI, tests, blood, pee, and vaccine!?! 5/3/2007.
• 5/3/07 received first ‘Tovaxin’ shot @13:09. Did MRI, peg test, math test, quality of life survey, speed walk test, pee, and 19? vials of blood. EDSS 3.0. (Visit 4)
• 5/9/07 Second ‘Tovaxin’ shot scheduled 6/7/07. Told no MRI.
• 5/17/07 Opexa announced the 150 patients needed have now been enrolled.
• 6/7/07 received second ‘Tovaxin’ shot @11:56 No MRI, peg test, math test, speed walk test, pee, and 13 vials of blood. (Week 4/Visit 6) EDSS 3.5
• 6/11/07 said the study monitor inquired about my allergies.
• Third ‘Tovaxin’ shot scheduled for 7/6/07. 10am MRI check in, 13:30 appt at Dr.
• 7/6/07 10:00 MRI 13:30 appt at Dr. Did MRI, peg test, math test, speed walk test, pee, and 13 vials of blood. Received third ‘Tovaxin’ shot@ 14:16 EDSS 3.5.
• Forth ‘Tovaxin’ shot scheduled for 8/3/07. 10am MRI check in, 13:15 appt at Dr.
• 8/3/07 10:00 MRI 13:15 appt at Dr. Did MRI, peg test, math test, speed walk test, pee, MSQLI, and 13 vials of blood. Received forth ‘Tovaxin’ shot@ 14:30 EDSS 3.5.
• Saw Dr. 10/12/07 at 13:30 about a difficulties in gait since 10/1/07. Got even worse 10/8/07, Recommended Solu-Medrol treatments. EDSS 6.0, Got infusions 500mg b.i.d., 10/16 – 10/18, Solu-Medrol pack for 6 days following this. Last pill taken 10/24/07.
• Fifth ‘Tovaxin’ 10/25/07. Peg test, math test, speed walk test, pee, no MRI, 13:15 appt at Dr. EDSS 4.0. 12.5 Vials draw was a hard draw due to Solu-Medrol infusions, 6 sites. Normally give 13 vials.
• Dr. 11/20/07 1:45, MRI 11/21/07 at 11:00 13 Vials of blood, easier this time. . Peg test, math test, speed walk test, pee. EDSS 3.5.
• Next appt. 1/18/08 13:00, MRI at 15:00.

April 03, 2007 07:00 AM Eastern Daylight Time from Opexa’s web site:
David McWilliams, president and chief executive officer of Opexa, commented, “We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 – 45 x 106 T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 – 45 x 106 T-cell dose.”

Welcome to the site TWG!

That wasn't long winded at all. I only wish my wife and I had documented things so well. Thank you!

Bob

Welcome TWG,

I am going to give my bag-o-blood on 12/14 for the extension. You kept pretty good track! That's it to a T. I guess that's why protocol is like McDonald's. It's the same wherever you go! Anyway, I too, feel like I'm on the placebo. I didn't have to do steroids, but came close to asking for them during my last relapse. I had pretty much been a 1.5 up until the trial. I had two relapses during the trial as well. I am only a 3 to 3.5 (it goes back and forth it seems like each visit) but basically all the time up to the trial MS was just a nuisance.

I suppose when you are at 6 you feel like 3 is just a nuisance. Anyway, I wanted to say welcome and get let's get ready for the extension trial!

Hi everyone,

I got my first bit of information about the extension study and when I go back to my clinic in January I must decide whether to continue or not. I plan to continue but just wondered what others in IIb feel about continuing. Does anyone know if they will tell each of us what we were getting (vaccine or placebo) so we can make a better decision? If I know I'm getting placebo then maybe the real thing will allow me to improve some but if I'm getting the real thing then I'll know that this may be as good as it gets on Tovaxin. What do you guys think?

Marcia

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Marcia

Hello Marcia,

We must be fellow Lexington AIN Tovaxin enrollees! It also sounds like we may be in a similar time frame in the study. My 1 year is up March 23 and like you they will talk to me about the extension study during my next visit at the end of January. Regardless of our individual situations, in the big picture things must be going well for the study or they would not even be doing an extension.

As for the extension, yes I am planning on enrolling. Up until about 3 weeks ago my MS had been very stable with improvements in several different areas. However, about three weeks ago I had a "thoracic" flare that far exceeded Tim's 4-day rule. This flare was a bit unusual in that it was almost entirely sensory with little motor involvement. It makes it really interesting to walk though when you can't tell if your feet are actually touching the ground or not. Anyway, a round of Solumedrol settled things down but not being able to do my normal activities plus dropping my workout routine dropped my endurance down quite a bit. Now I'm back to my normal routines to build my stamina back to where it was. The good thing is that everything seems to work like it did pre flare but it just doesn't work as long. Most of the sensory symptoms are back to "normal" and the leftovers seem to continue to improve.

Take care,
Mike

Hi Mike,

Up until now, all the other people in the study at AIN were unknown to me. They do a pretty good job keeping us all away from each other.

I'm no better and no worse since the beginning of the study. I had my biggest flare up right after I was diagnosed. The lumbar puncture was an awful ordeal. The dr that performed it at the hospital was a real "a-hole". He hit a nerve and made my leg shoot out then had the nerve to tell me I needed to keep still like it was all my fault that he hit the nerve. Needless to say I got the headache and after 8 days it took the blood patch to make it go away. I think the stress of the dx and the awful LP sent me into the exacerbation. Until then I didn't know what a flare was and it wasn't until I could see it in retrospect that I knew that's what happened. I agreed to go into the study within a month of dx and then finally after AIN got their paperwork in order I had my first vaccine on March 1, 2006.

I really hope they can tell us if we're in the placebo group or not. I think it would help us make a better decision on continuing.

If we continue, are we automatically placed in the stage III trial or do we just go on open label till it's approved?

Thanks,
Marcia

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Marcia

You just go into an open label protocol. I don't think they tell you. If you are going open label, I have decided that I don't care which group I was in, but I see your point about that information being helpful to decide if you want to continue. It's easy for me since I've had two relapses while being in the study. Now having just written and read that, it would also be helpful to make the decision with those criteria as well. This whole trial thing is helpful to get the drugs to market but I have decided that being a guinea pig leaves a bit to be desired.

From all I've read though, aside from what Chris has been posting about Revimmune, I still think Tovaxin is our best bet in the here and now, so I'm hanging in there.

Hi Ssmme,



My understanding is that once all of the data has been analyzed and published, you can find out if you were on placebo or Tovaxin during the first year. I agree that it would be useful information upon which to base your decision as to whether or not to continue in the study, but because the study is a double-blind placebo study, unblinding patients before the study is completed would influence decisions and effect the end results of the study.



If you choose to go into the extension study, you will remain in an extension study until Tovaxin is approved. That is my current status.

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Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

I've made up my mind to go to phase III based on what opexa's press release stated

April 03, 2007 07:00 AM Eastern Daylight Time from Opexa’s web site:
David McWilliams, president and chief executive officer of Opexa, commented, “We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 – 45 x 106 T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 – 45 x 106 T-cell dose.”

Another reason I believe I am on the placebo, 100% reduction in ARR at the level they are using for this study, I have had 2 relapses thus far and have had all 5 shots.

Tim - What does the extension study include? Will we continue to have the MRI's, timed walks, peg and number tests or will we just come in for injections periodically? I know the clinic will give this information at the appropriate time but I'm not scheduled to be there until mid January for my final follow-up for IIb.
How often has it been necessary for you to provide additional blood for vaccine or are they still making it with your original pint?

(My apologies if you have expressed this information in another thread or much earlier in this one but I haven't much uninterrupted time to read the older posts. I try to keep up with the new ones at least.)

Thanks,
Marcia

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Marcia