Loobie's second shot update

Loobie · Post by **Loobie** » Sun Jan 14, 2007 5:20 am

I was told that after the year and we are unblinded, that we will have access to our drug. That is the biggest reason I got in it. It's only a year, and you get the goods even if you're getting placebo during the trial. This sounded like two good things to me; one is that you get to help a potentially good med. get to the market and two, you get it anyway since it is custom made for you.

IHaveMS-com · Post by **IHaveMS-com** » Sun Jan 14, 2007 5:25 pm

Hi Lew,

I would not say that a patient will be unblinded after 12 months. That would imply that they will be told whether or not they were receiving vaccine or placebo. If you feel it is important to know if you were receiving placebo or vaccine during the 12 months, ask if that information will be given before entering the study.

At the end of a their 12 months, everyone in the current IIb study will transition into an extension study, and as you pointed out, will receive their own personalized vaccine, "our drug". Everyone in an extension study will receive the vaccine until it is approved. The extension study is listed as a one-year study, but it designed to be extended yearly until the vaccine is approved.

Last month, after 3 years in the dose escalation and safety study, I moved into an extension study. I believe I am the first person to be moved into an extension study. I had to sign new consent forms, have my blood tested for MRTCs, which I am still producing, and give a bag of blood from which my new vaccine is being made.

Some people stop producing MRTCs after being on Tovaxin. If that is the case, they will be tested every 2 months to see if the MRTCs return. Of the 114 patients treated in the late 1990s, about 15 were located and enrolled in the retreatment study. Of those, I believe 2 were no longer producing MRTCs.

connieb · Post by **connieb** » Sun Jan 14, 2007 6:31 pm

Hi Tim-- I am curious about the fact that only 15 people of the 100+ treated in the 90's ended up in the extension study. Do you have any ideas or guesses about why so few were located? Had they all completed the original study or was that the number enrolled and then some dropped out? Was the vaccine not effective for them? Were more than 15 contacted but chose not to participate? Was this vaccine the same one used in the current study or one of the earlier versions? As always many thanks for your answers-- you have helped me understand the potential of this treatment a lot better.

IHaveMS-com · Post by **IHaveMS-com** » Sun Jan 14, 2007 7:41 pm

Hi Connieb,

Hopefully this will make the webpage easier to understand. I had questioned in an earlier post how Tovaxin had gone from its original 40% effaciacy to it's current (claimed) 92% effaciacy and in his email (which I turned into that webpage) Tim is showing me a Tovaxin history/timeline showing it's different effaciacies in these articles (links).

Quite a few questions. Take a look at what Lyon posted on his home page. It is some information I sent him on the progression of the vaccine. I believe about 40+ people where left at the end of the 114 patient study. Of the 40 patients they were able to reach about 20+ and about 15 were interested in being retreated. I cannot tell you why the others did not.
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Lyon · Post by **Lyon** » Sun Jan 14, 2007 7:53 pm

I think this is the page Tim is talking about http://www.msu.edu/~lyonro/tovaxinhst.html
I didn't want anyone to freak out when they click on my www link to find that it instead regards helminth immunomodulation

Bob

Loobie · Post by **Loobie** » Mon Jan 15, 2007 5:41 am

Tim,

Actually that is good to hear. Getting unblinded to me after a year isn't that important as long as I know I am getting the goods during the extension. My main goal was to get on it in the first place and whether I know I got it the first year isn't a big deal as long as the extension is done unblinded.

Lyon · Post by **Lyon** » Mon Jan 15, 2007 12:36 pm

Hi Tim,
I'm not sure if you'll know but I might as well ask. After the first year of the trial will participants be able to continue dealing with the "satellite" in their state or does treatment revert back to Houston at some point?

In other words, did these satellites agree to continued involvement until if/when Tovaxin is given the wink by the FDA?

Thanks,
Bob

IHaveMS-com · Post by **IHaveMS-com** » Tue Jan 16, 2007 1:31 pm

Hi Lew,

The extension study is unblinded and patients will continue getting Tovaxin until FDA approval. If you are willing to take the placebo chance, you for sure will receive the real thing until it is approved. That is the big decision a lot of people must contemplate.

Bob, Patients will stay with the site they enroll with. I enrolled in Houston and must stay there. The only reason that someone would not continue where they started would be if the site did not continue as an extension participant. I assume they will want to.

If someone moves during the study, they must continue with the site they started at. This will keep all of the evaluations consistent.

Lyon · Post by **Lyon** » Tue Jan 16, 2007 4:46 pm

Thanks Tim, I was hoping that would be the case but I hadn't previously heard.
Bob

IHaveMS-com wrote: Bob, Patients will stay with the site they enroll with. I enrolled in Houston and must stay there. The only reason that someone would not continue where they started would be if the site did not continue as an extension participant. I assume they will want to.

If someone moves during the study, they must continue with the site they started at. This will keep all of the evaluations consistent.

Loobie · Post by **Loobie** » Wed Jan 17, 2007 10:37 am

Thanks Tim,

I'm glad that is the case and not just something I thought I heard (more like hoped). I think I can gut it out until the trial is over no matter what. I'm off my neurotic Nancy pills and have settled myself down (the 4 day eval. advice really helped). It also really helps that my eyes aren't flaring up so bad now that I'm not sick, but whatever it takes.

IHaveMS-com · Post by **IHaveMS-com** » Wed Jan 17, 2007 5:47 pm

Hi Lew,

Since you mentioned the email I had sent you and my 4-day rule, I thought I would post it. There isn't anything in the email that you had not publicly commented on in one of your postings.

I thought I would drop you a note. I don't know if I can ease any of your anxiety, but I will tell you what I do and a little more about my MS.

Since relapsing remitting does exactly as its name implies, I have always used the 4-day rule. I did not consider that I had a problem or an improvement unless it was present for 4 or more days. Trying to analyze every little twitch your body has will start to drive you nuts. It is like someone looked at you and said "I think I see an ant crawling on you." Whether there is really an ant or not, you will feel all crawly.

There are approximately 83 symptoms of MS, and on any given day they will wax and wane. Anxiety, heat, fatigue, etc. can heighten any one of the symptoms. When I am fatigued, I have greater difficulty walking. When my anxiety level rises, it is like I am plugged into an electric outlet and my nerve endings buzz.

My MS was very fast and very aggressive. I went from running cross country to and EDSS of 5.5 in about 3 1/2 years. I have primarily CD-4 MRTC, but I do have some CD-8 MRTC. The CD-8 cells are what you would expect to find in a person with primary progressive. I assume I am a hybrid between RRMS and PPMS. My MS was progressing so rapidly, that it was felt that I was transitioning into secondary progressive.

Even though your sleeping through the night does not pass the 4-day rule, I do find that promising. Since you have had 5 years of interrupted nights, to see the number of interruptions decrease would be a great improvement. It would not change your EDSS, but it would change the quality of your life. If you currently get up 3 times a night, and don't start getting up 4 times a night, that is what you should be looking for. The bottom line for Tovaxin, is that it is hoped that it will keep people from getting worse.

Lyon · Post by **Lyon** » Sun Jan 21, 2007 1:32 pm

IHaveMS-com wrote: Since you mentioned the email I had sent you and my 4-day rule, I thought I would post it.

Thanks Tim, I mentioned your four day rule to my wife and it seems that is something good for anyone new to MS to keep in mind. During our recent trip to Las Vegas we did a LOT of walking and she was concerned that a relapse was coming on. Now it seems what she experienced was probably due to fatigue.
Bob

pvns2005 · Post by **pvns2005** » Tue Jan 23, 2007 4:58 pm

I go for my first injection of Tovaxin tomorrow (01/24/07). Check my website link for updates.

Lyon · Post by **Lyon** » Tue Jan 23, 2007 5:36 pm

Congratulations Chris and best wishes!
Bob

PS...Jamie and I are hoping to retire to Alabama in 6 or 8 years....neighbor!

pvns2005 · Post by **pvns2005** » Thu Jan 25, 2007 11:41 pm

First injections are out of the way. My second injections are scheduled for February 21, 2007. I will update my website with any improvements.

Good luck to all...

http://blog.360.yahoo.com/pvns2005