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Joined: Feb 02, 2004 Posts: 864 Location: California, USA
Posted: Tue May 29, 2007 1:23 am Post subject: Tovaxin Users
Member havingms has proposed we put together an informational thread for Tovaxin users. If you are on/have been on Tovaxin therapy, please consider answering the following questions in this thread for the benefit of others.
Thanks!
When did you receive your first vaccination?
What dose did you receive? How many millions of cells?
What was your overall experience? Did you get better or worse?
What side effects did you notice? _________________ Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
This question only applies to someone in the I/II dose escalation study. I was first in the low-dose group receiving 7 to 9 million cells. On January 31, 2005, I was moved into the mid-dose group. Since I was in a study to show safety and the proper dose, I was moved into the mid-dose group after the mid-dose was shown to be safe. The mid-dose is what everyone in the IIb trial is currently receiving or will receive when they move into the extension study. The mid-dose is 30 to 45 million cells.
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How many millions of cells?
The question of dose is only relevant to the I/II dose escalation study. Anyone who is currently receiving Tovaxin will be getting the mid-dose, with the exception of a few people (2 or 3) who are finishing up the high-dose part of the dose escalation study. The high-dose is up around 90 million cells.
Quote:
What was your overall experience?
Excellent
Quote:
Did you get better or worse?
My EDSS went down and I have regained many lost functions. I would add to this question a third response -- Did you get better, worse, or stayed the same.
I hope everyone has great disease reversal, but the bottom line is, if going forward, you are never worse than your worst day in the past, Tovaxin is working.
From what I can tell, the people in the extension study wake up each morning looking for what function they have regained today. I hope it works that way for everyone, but that is not what the hope for Tovaxin. Its purpose is to stop the attacks.
If when you wake up each day, you do not sense any regained function, you can be disappointed in your body's inability to restore itself. If on the other hand, you wake up and are feeling more disabled that your were at your worst point, then you can be disappointed in Tovaxin.
Some things to consider if your are in the Tovaxin trials:
1. It isnt an attack unless it lasts for more than 4 days.
2. I will not consider my EDSS to have changed unless it stays changed for 2 or more consecutive assessments.
3. I will remind myself that the hope for Tovaxin is to stop the attacks. Any restoration of lost functions is up to my body.
4. I will not expect to sense any difference until at least 100 days after my first injection of the real stuff, and it is possible that it might take 4 treatments plus 10 days for my immunity to get up to a sufficient level to fend off attacks. http://www.thisisms.com/ftopict-5631.html
5. If I get some lost function back and I lose it again, I wont think that I am having an attack but rather, that the body needs to do some more restoration to the nerves that control that function. But, if I get back some lost function and that restoration lasts for more than 8 weeks without interruption, it is for real, and in that case, if you lose the regained function after 8 continuous weeks of having it, discuss that with your neurologist.
6. There may be a point during the 100 days that you sense things are starting to get better. Use the day before you get that feeling as your baseline. No matter what ups and downs you encounter going forward, if you don't drop below your baseline, Tovaxin is working.
7. This is a patient-specific vaccine and there are a lot of other patient-specific rules. And most important of all, results will vary http://www.thisisms.com/ftopict-4133.html _________________ 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.
Last edited by IHaveMS-com on Tue Jun 10, 2008 12:54 pm; edited 4 times in total
Posted: Tue May 29, 2007 9:37 am Post subject: Re: Tovaxin Users
When did you receive your first vaccination?
5/25/07
What dose did you receive? How many millions of cells?
I know that it was 2 injections, one in each arm. I believe it was 1cc per arm, but don't hold me to it, they were very slim with the details.
What was your overall experience? Did you get better or worse?
I have been diagnosed with clinically isolated MS. My one and only flare was last summer and I have not had any new symptoms since then. Since the first injection, there is no noticeable difference than before I had the shot.
Joined: Sep 12, 2006 Posts: 901 Location: Dayton, Ohio USA
Posted: Tue May 29, 2007 10:35 am Post subject:
First injection - 11/27/06
Dose and cell count - I am unsure about that. I also received one injection in each arm
Overall experience - Have had some worsening of symptoms since the beginning of the trial but neuro. thinks I was in a relapse when we started based on my feedback ex post facto. Feeling pretty stable right now, but have lost lots of endurance capacity and coordination from my most recent relapse.
Side effects - None at all. No inj. site reaction and no reaction to the injections.
All Phase IIb participants could be in the control or the drug group. I have had my last injection until the extension starts.
Posted: Tue May 29, 2007 3:03 pm Post subject: Greetings to the Tovaxin group.
When did you receive your first vaccination?
October 2005
What dose did you receive? How many millions of cells?
Appx 90million
What was your overall experience? Did you get better or worse?
I gave the first blood bag in May of 2005 and received the first vaccination in the fall of 2005. I received the highest dose, about 90 million cells. The following month was close to amazing. I felt like my old self. Running up stairs 2 at a time and walking about my neighborhood and cycling too. I was so excited about the whole thing. By the holidays though, I had a mysterious decline in energy and something that felt like an exacerbation but not exactly. My symptoms were increasing again. At the end of the first year (fall 2006) I had declined quite a bit. In hopes of some relief I did one round of steroids in December 2006, and again a brief improvement was followed by extreme numbness of my feet and legs that persisted for several months. The research doctor could offer no explanation other that the Tovaxin was not shown to be helping me and that maybe I had entered the secondary progressive stage of my disease. I am currently experiencing symptoms without a break, and am quite limited in the mobility of my legs and quickly exhausted. Also very heat sensitive. Above 65F I stay home until it cools down.
The most interesting part of the story is that I had no MRTCs at the mid point of the study year and that extended for 10-12 months. So, from that point of view the vaccine did what it was supposed to do. It just didnt help me for some unknown reason.
Unfortunately, my participation in the Tovaxin study was followed by a worsening of my condition and a gradual but continuous increase of my EDSS rating from a 2.5 (when I started) to a 7.
What side effects did you notice?
The main one, is that overall, I have gotten a lot worse. I also did have injection site reactions. They got more and more intense after each consecutive shot. They included redness, swelling (like there was an egg under the surface of my skin/muscels) and changes in the surface of my skin, (reminded me of chiken skin). The site reaction area increased from the size of a quarter (1st shot) to the size of an orange/banana (4th shot). The reactions would dissapear within a week or so.
Now I am in the re-vaccination phase and will receive 30-45 million pretty soon. I hope that it will make a difference.
Joined: May 04, 2006 Posts: 3456 Location: Mid-Michigan
Posted: Tue May 29, 2007 8:32 pm Post subject: Re: Greetings to the Tovaxin group.
havingms wrote:
They included redness, swelling (like there was an egg under the surface of my skin/muscels) and changes in the surface of my skin, (reminded me of chiken skin). The site reaction area increased from the size of a quarter (1st shot) to the size of an orange/banana (4th shot). The reactions would dissapear within a week or so.
Hi havingms,
Are you sure? The Tovaxin I/II was a safety and efficacy study and I think what you're mentioning would have brought things to a screeching halt.
Besides, it doesn't make any sense. All they're doing is injecting your own cells back into you.
Bob _________________ Wife diagnosed with RRMS in Feb. 2006.
I am absolutly sure. Even though the cells are your own, their purpose is to cause an immune response so your immune system will begin to recognize the MRTCs as the culprits and eliminate them. I think thats why its called a vaccine.
The dose I received was high and I believe it might have been too much for my system. Although that might be debateble, I definitly had very strong injection site reactions, especially during shots 3 & 4.
This whole time I have felt that something has been amiss. While all testimonials I have read seem to be positive or at least neutral. I have wondered why this has not worked with my body.
Since the beginning (and before) of my participation in the study my white blood cell count has been below normal. It has ranged from 3.7 at the beginning (before the vaccine) all the way down to 2.9 during the vaccination period. I suspect that there is a long term pathogen such as CPn, Lyme or something else.
It is possible that there are other cells responsible for the distruction of the CNS such as B-cells. Also, the first vaccine covered and identified 6 or so peptides which probably did not address all the MRTCs. Of course I am just speculating.
All I know for sure is that I went from being able to walk the 500 yards easily to not being able to walk without a cane and the help of walls. Maybe it is a coincidence and has nothing to do with te vaccine. I hope I find out soon.
Joined: May 04, 2006 Posts: 3456 Location: Mid-Michigan
Posted: Tue May 29, 2007 9:50 pm Post subject:
Hi havingms,
havingms wrote:
Even though the cells are your own, their purpose is to cause an immune response so your immune system will begin to recognize the MRTCs as the culprits and eliminate them. I think thats why its called a vaccine.
Yes, you're absolutely right.
havingms wrote:
the first vaccine covered and identified 6 or so peptides which probably did not address all the MRTCs. Of course I am just speculating.
I don't remember the exact number but you're right, there were just a few peptide strains used before and around 100 this time.
havingms wrote:
I hope I find out soon.
Me too and I wish you the best. Correct me if I'm wrong but for you this is an extention study so you will be on the real treatment for sure.....right?
Bob _________________ Wife diagnosed with RRMS in Feb. 2006.
Hi Bob.
Yes that is correct. This phase is called the re-treatment phase or the extension of the IIa study.
There were no placebos in this study. I have been receiving the real thing from the start.
Take care.
Joined: May 04, 2006 Posts: 3456 Location: Mid-Michigan
Posted: Wed May 30, 2007 2:25 pm Post subject:
Hi havingms,
I know this situation can't be more interesting to anyone else than it is to you and my deepest wish is that the higher number of epitopes does the trick for you. That said, I also find your situation extremely interesting.
I know that you don't have all the answers and in fact would like answers but is there more that you can tell us about your situation?
You sound like you might personally doubt that what you have is MS or do you feel that you might have MS AND something else?
Do the trial coordinators give any indication of what they think your situation is?
Any idea when your first dose in this phase will be? Have you had the procurement for it yet?
Bob _________________ Wife diagnosed with RRMS in Feb. 2006.
Joined: May 04, 2006 Posts: 3456 Location: Mid-Michigan
Posted: Thu May 31, 2007 12:16 pm Post subject:
When did you receive your first vaccination?
Wife received first vaccination April 25, 2007 and second vaccination on May 23, 2007
What dose did you receive? How many millions of cells?
35-40 million in the IIb clinical trial.
What was your overall experience? Did you get better or worse?
EDSS assessment was done at the appointment for the second dose and wife was told that her EDSS has gone from 3.5 at the start of the trial to 1.0 at this point.
During the EDSS testing before the third dose, during the part where the neuro touches you in two places, my wife can now locate both places, although the neuro didn't mention an EDSS score.
What side effects did you notice?
Nothing. _________________ Wife diagnosed with RRMS in Feb. 2006.
Last edited by Lyon on Fri Jun 22, 2007 7:32 pm; edited 1 time in total
Joined: Jun 14, 2007 Posts: 133 Location: Historical Glendale, OH: Home of the Squirrrels
Posted: Thu Jun 14, 2007 10:26 am Post subject: Re: Tovaxin Users
Arron wrote:
Member havingms has proposed we put together an informational thread for Tovaxin users. If you are on/have been on Tovaxin therapy, please consider answering the following questions in this thread for the benefit of others.
Thanks!
When did you receive your first vaccination?
What dose did you receive? How many millions of cells?
What was your overall experience? Did you get better or worse?
What side effects did you notice?
Hi all--
Okay, Tim just linked me here via e-mail... I'll just take the topics as they roll down the menu and hope I don't mess 'em up too much! Here goes:
First vaccination: May 2, 2007
I have no idea about the dosage... since I'm in trials, is this info even available to me?
I saw subtle improvement within 48 hours after those first jabs that just got "really" better as time went on.
No side effects. _________________ Jane the Pain
It would be good if you posted the same improvements that you posted on the other site. That would give people the opportunity to read about the specific improvements you have had and possibly ask you some questions.
Bob, I think you should do the same thing on this thread. My brothers are threatening to hide my laptop.
I assume a lot of people watch the postings here, and some did not fit the protocol for the IIb trial. I will paste in here the same thing that I mentioned on the other site.
If you would like to see the protocol changed for the phase III study, you might look at the protocols that were used for the CRAB drugs and other approved MS drugs. If the age or EDSS span was greater for any of those drugs, present that information to the neurologist at the study site and ask him/her to send this information on to Opexa for their consideration. Please, please, please, won't make anything change, but supportive information might. _________________ 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.
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