Questions and responses to the 100 plus days club members

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby Terry » Sun Jun 08, 2008 5:21 am

It is Sunday morning, Lew, and I'm hoping that you had the BEST DAMNED TIME last night.

Smiling in Cincy...
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Postby Loobie » Sun Jun 08, 2008 5:37 am

OK,

I'm still so happy this morning. I went to the party and it was my wife's side. So I'll set the stage: Kids gone about 9:00pm, adults just getting revved up since the beer was a flowin'. "Night cornhole tournament" begins, major beer and shots flow. Shit gets crazy. It was a blast. I had 4 freakin' beers! I haven't had 4 beers in a long time. Everyone (I skipped out on this since it was FULL contact) starts playing musical chairs and we trashed about 5 party rental chairs. Well about halfway through the night I was feeling my legs a bit because my brother in law has a big ass piece of property and horses and stuff, so the ground was all clumpy again. I made it through that, did some "MS stumbling", but once again, I sat down for 15 mins. or so, and I was good again.

Now here's the awesome part. While me and my wife's sex life is still pretty active, we don't get busy AFTER things like that anymore. I'm always wiped out, and if I've had really any alcohol, you can forget about it. Well last night we didn't forget about it! :wink: . My legs feel wonderful this morning (compared to lately), I was able to walk down the stairs without smasing up against the hand rail to favor and not bend the left leg so much. That is how I go down stairs. The freaking paint above the handrail is actually hammered because of how bad I hug it; especially first trip down in the AM.

Bob,

You are acute in your observations about this stuff seeming pretty quick. However, I've been feeling "better in patches" for about a month now but was not going to post since I wasn't at a min. of 100 days and it was a bit transient at first. Like I always say: could it be the Tovaxin or just MS going down for a bit on it's own. Don't know and don't care, just going to enjoy it for a while. My daughter is going with a friend to Hillsboro today, so I'm going to sunbathe! I'm like on a kick to do stuff I know I shouldn't.

Hell, I might even run with scissors later!
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Postby Loobie » Sun Jun 08, 2008 6:31 am

Even though Bob's my idol, I try not to answer my own posts (couldn't resist Bob :lol: ), but after I thought about my last post I thought that people may think "too much information". But there hasn't really been a lot of discussion of sex stuff on here. I'm not trying to start a sex thread in the Tovaxin forum. I don't know about all the women on here, but at least for this guy the diminished sexual function is an absolute huge part of this disease. Important for men and women, but I can say from the male side it's a big part of feeling virile and 'manly'. It's a giant part of our self image and when you're married I think it's one leg of a three legged chair sometimes. Anyway, I just wanted to say that I hope I didn't overstep on my description, but I do think we need to open up some good talk about it. I mean what makes you feel better when you are not feeling good? It can be like a panacea for the blues and there are times I want to know what others do to keep the physical part of the love alive.
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Postby Lyon » Sun Jun 08, 2008 7:06 am

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Postby IHaveMS-com » Sun Jun 08, 2008 6:46 pm

Hi to all and congratulations to Lew,

It is super to see Lew moving in a positive direction. Reading about his decline and his commitment to hang in there so that he could get the “real stuff”, was gut wrenching. You can see that it took 3 treatments before the level of immunization was sufficient to allow the body to start repairing some things. As Lew pointed out, two weeks ago, he could have done only about ¼ of what he is doing now.

It is likely that there may be someone in the study who will need 4 treatments plus 10 days before things start to turn around. My protocol say that at the end of the series of treatments, if the patient is still producing MRTCs, the physician can request that more vaccine be made. If your clinic is running several studies, the physician doesn’t remember the fine points of the protocol. It is up to you to point out anything in the protocol that might be of benefit to you.

Since Lew has been kind enough to share the empirical data on his study of micturition, I will use the bladder as an example of what people in the study should be aware of. For the sake of this example, lets say that there are 10 nerves that control the urge to go (piss, pee, drain the main vein, drain the lizard, water the lawn, put out a fire, or as I like to say piddle). Since there is always a few spare nerves, lets assume that 6 is the threshold before you notice some loss of function.

Now, lets assume that a person with MS has had 5 of the 10 nerves demyelinated and is now experiencing some loss of control. If Tovaxin has stopped the attacks, and the body remyelinates 1 of the 5 that were damaged, the lost function will return. Since the repaired nerve is probably not myelinated as well as when it was new from the factory, we should expect a few short circuits from time to time.

So if the 8 ounces drops back to 5 ounces for a week or two or maybe longer, that would be something to expect to happen to some of the repairs. If the body only partially remyelinated the 6th nerve and went on to work on something else, then that regained function is going to go on the fritz periodically. So, new rule: If I get some lost function back and I lose it again, I won’t 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. Corollary to the new rule: If I get back some lost function and that restoration lasts for more than 8 weeks without interruption, it is for real. In this case, if you lose the regained function after 8 continuous weeks of having it, I would discuss that with your neurologist. The real bottom line here is that if you regain some lost function and you lose it again, but you are not getting worse, then Tovaxin is working.

In my study there are patients with RRMS and SPMS. The data presented so far is that everyone at least a ½ point reduction in his or her EDSS. This would indicate that Tovaxin is likely to work on SPMS. The current study is for RRMS, and I think you need to continue to be classified as RRMS to stay in the study. I assume you understand what I am saying.

I hope that Lew continues to share personal information about his improvements as well as small rather insignificant changes. If you couldn’t peel a shrimp yesterday but you can today, that is something worth being pleased about and commenting on. I hope that Lew’s willingness to include us in his trial journey will encourage others to let us know how they are doing. Unfortunately, when you are feeling better and can be out doing things again, it is a sacrifice to sit in front of the computer and post news about how you are doing. People who are not doing well, post to try and get some answers. Silent positives will make the decision to get into the next study a much harder decision for those who have to make it.

I keep saying that I am going to leave for a while. I have been hanging around to see what Lew had to say, so maybe I can disappear for a while now.

Remember the rules:
1. It isn’t 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.
5. If I get some lost function back and I lose it again, I won’t 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. This is a patient-specific vaccine and there are a lot of other patient-specific rules.
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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Postby Lyon » Sun Jun 08, 2008 7:05 pm

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Postby Loobie » Mon Jun 09, 2008 3:46 am

You forgot the old Irish classic "watering me boots"! I think that's the MS classic as well since we all have such strong streams 8O .
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Postby Lyon » Mon Jun 09, 2008 6:22 am

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Postby Loobie » Mon Jun 09, 2008 9:27 am

I ended up finishing my weekend as strong as I went into it. I've decided the only way to really see what effects this is really having is to just update condition once a week as long as there is something to report. That way I don't knee jerk if something comes up. I've gotten pretty good about waiting the 4 days at least to report something positive. I've got to make sure that if I have a bad day I don't react, but instead wait the four days. My enthusiasm in my last two posts was probably a bit much, but to sum it up; there's nothing like having your legs feel "equal" when you've had to favor one for so long. Just favoring one leg over the other is more fatiguing than you would think. It's really noticeable when you favor it and then don't have to for a while. I hope it sticks because I'm really enjoying my new found 'straight gait'. Still having problems maneuvering in tight spaces but the whole walking thing is less fatiguing to me, at least for the time being (fingers crossed). We'll see how this super hot work week goes and hopefully next Friday I can post about another good week.
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Postby Lars » Mon Jun 09, 2008 4:34 pm

Lew,
We just had an interest thread about beer on the General discussion board. You found the missing component, It's not just beer it's sex and beer. You are my hero.
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Postby Loobie » Tue Jun 10, 2008 3:31 am

Thanks Lars,

It's hard drinking and screwing all weekend, but somebody's gotta' do it. :)
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Postby Lyon » Tue Jun 10, 2008 5:28 am

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Postby Lars » Tue Jun 10, 2008 7:35 am

Tim,
You made mention in your 100 day club post that possibly 10 out of 150 folks would post. Given the seemingly narrower path, i.e those who are not producing MRTC's or have been dropped for other reasons, the 150 number must be much smaller at this point. Thoughts?
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Postby IHaveMS-com » Tue Jun 10, 2008 11:46 am

Hi to all,

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 is. 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 than you were at your worst point, then you can be disappointed in Tovaxin.

New rule: 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.

You made mention in your 100 day club post that possibly 10 out of 150 folks would post.


My estimate that only 10 out of the 150 trial participants is based on the "good intentions, but no follow through" reality. Many people emailed that they were going to be keeping journals and posting regular results, but I have yet to see that happen.

When people feel bad, they look for answers. When people feel good, they hold their breath and hope it is for real. There is very little incentive to post that you are doing better. I hope people don't look at posting good news as being boastful. More likely than not, they are crossing their fingers and hope that the new found relief continues and don't want to jinx it.

Given the seemingly narrower path, i.e those who are not producing MRTC's or have been dropped for other reasons, the 150 number must be much smaller at this point. Thoughts?


It sounds like a very high percentage of trial participants will be continuing on into the extension study.

David McWilliams, chief executive officer of Opexa, commented, “The Phase IIb trial continues to be executed according to our plan and the level of dropouts has remained low. To date only 150 patient visits remain of the approximately 2,500 total visits comprising the trial. We look forward to reporting topline results on our primary endpoints in September. McWilliams continued, “We are also encouraged by the strong interest in the open label extension study for Tovaxin offered to all participants completing the Phase IIb study. Over 90% of patients who have completed the one-year TERMS study to date have elected to enroll in the extension study.”
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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Postby av8rgirl » Thu Jun 12, 2008 9:40 am

I am so encouraged by all of your postings that I can't even begin to tell you how much.

Since my last injection on Sept 21 and my last appt in the Phase IIb TERMS study, I have, to put it bluntly, declined. In December, I started out with a cold that turned into one of the worst sinus infections I have ever had. I had 2 rounds of antibiotics which didn't even touch the infection. After begging to get into see an ENT doc, it was discovered that I had a staph infection in my right sinus. I was completely down and out with the infection from mid-December until the end of January. It put me into an infection-induced relapse. I was not treated with IVSM as it would have put me out of the trial. (I had a exacerbation last August and was treated with 3 days of IVSM.)

After 2 months of antibiotics, I was finally back on my feet again, literally.

April 1 was my last Tovaxin TERMS appt. By mid-April, I was in the midst of a full blown exacerbation again. After much discussion back and forth between the clinical trial neuro and my local neuro (450 miles apart), it was finally decided that I could have 3 days of IVSM since I was technically not in the trial, and the blood draw on the 1st revealed no MRTCs. I would have to wait the 90 days for the redraw.

I am now scheduled for the redraw on June 27th.

I have another sinus infection.

I cannot get anyone from the clinical trial office to return emails or phone calls to change meds. I have contacted them for med changes regarding the increased leg pain I am suffering and I am not getting any responses from them. It takes two or three emails to get any kind of return email and then it's oh I haven't heard from the doc, I will get back to you.

Then if I go see my local neuro or PCP and do anything, they get a nasty phone call from the clinical trial doc because I/they are doing things outside the protocol that I signed. So, I suffer.

What the hecks going on? I feel like I am in no-man's-land here.

Prior to this, I got immediate response. They have a new person who is the study coordinator. She's very nice, but not as responsive as the other one was. She's not a nurse. I don't think she understands the urgency of the situation.

Any ideas? Do I wait til my June 27th appt and hope that this sinus infection doesn't get any worse? Or do I keep bugging them?

Also, will it affect the MRTC production? I want back in the extension study. I am out of options for treatment. I have failed everything else. Chemo is my next option for treatment. I am not ready for that.

Thanks for letting me vent....hopefully someone will have some good advice for me! I am tired of being sick. I have been sick since December.
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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