Its over

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby av8rgirl » Tue Dec 02, 2008 9:39 pm

HEC wrote:Had an MRI and neuro visit yesterday to decide which CRAB drug to start taking. For me, Copaxone was the best option as R, A & B could all potential mess with my already messed up thyroid. My daily injections will start right around Christmas - oh, joy!

My brain MRI showed one new lesion on the pons which was disappointing to me (I got the vaccine last year and hoped that meant I wouldn't have anything new upstairs), but that was the only thing new since last year's 3T, and it's not triggering any symptoms that I know of. No evidence of atrophy or ventricle weirdness, and no active lesions, so that's all good news. I had an attack last summer involving my right optic nerve (for which I tested MRTC negative during the attack - odd), but there wasn't any evidence of a lesion there, so that was a relief.

As for the Tovaxin trial, my neuro said that while it's hugely disappointing, it's best case scenario to have a trial cancelled due to funding vs. due to an adverse reaction by a study participant. In the event Opexa gets their data together and it looks promising, there is always the potential that they will receive more venture capital funds if they don't get acquired by a bigger company and then they can start a new trial. He said he had 11 other studies going, but none of them would be appropriate for me. If I hear of anything in the future, I will pass it on to the group.


thanks for the update. I've also tested negative for MRTCs during a flare - a confirmed flare! Go figure.

I received an interesting email from the site coordinator yesterday. They wanted an update on all my meds and health status. I found it very curious. The doc doesn't want a termination appt face to face with me but they want an update on all my meds and recent health issues....

HEC, check your Private Messages!
“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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Postby Lars » Wed Dec 03, 2008 6:52 pm

Bob,
Yes, I was talking about those unwilling to take MS therapies, i.e. CRABS.
Yes, I was referring to my local MS group of which a large number have resisted CRAB therapy. Maybe it is where I live, but many have taken a holistic path. Diet, Acupuncture, Yoga, Allergy awareness, exercise, low stress classes (yes, we have that as part of our group offerings), blah, blah, blah. It seems those on therapy have gone through the normal course, which seems to be changing CRAB drugs until they have tried them all will nothing but poor results. Actually our biggest advocates of the holistic path are those who have spent years on therapy. They are mostly doing well.
Be Well,
Lars
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Postby Lyon » Wed Dec 03, 2008 7:35 pm

oo
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Postby Lars » Wed Dec 03, 2008 8:57 pm

Bob,
You are right, for me the stress thing IS huge. Of anything that I know for sure that worsens my condition, stress of any kind is at the top of the list.
Breathe,
Lars
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Postby patrickm » Fri Dec 05, 2008 1:16 pm

Hi All.
Because work has been so all-consuming over the last few months, and my energy and time have been at a premium, I've been largely absent from my normal haunts, both virtual and non-virtual. I have been reading occasionally over the past few weeks, thanks to HEC hipping me to the death of our study. And at that point, I was so flustered/POd/bummed/confused that I really didn't know what to even say. So, in a rare fit of good thinking, I said nothing.

I share most of the feelings that have been shared here. While I'm upset that Opexa couldn't acquire funding to go forward, once their topline data rolled snake eyes and the economy and financial sector went to hell in a flaming hand basket, the writing was pretty much on the wall. I was not and am not surprised.

While I'm upset, I'm not angry that they didn't pull the plug earlier. I understand how this has screwed some people who were on placebo last year (sorry Lars!), but I don't see how they had any choice. They presented at the conference on the 11th and obviously didn't rope anybody in and after that, they pretty much didn't have any choice. But as a business owner, I'd say that I wouldn't pull the plug on something until I absolutely, positively had to. The stakes here are obviously very high. And if funding had come through, then we wouldn't be having this conversation at all.

My nurse called me on Tuesday morning the 25th, and was almost in tears. I ended the call feeling more sorry for her because her empathy for all of us was so great. My doc had waited a day to call all of us while they tried to get answers from the Independent Review Board who I guess were swamped with calls from PO'd doctors and nurses. What I was told was that Opexa told their docs that there would be no cash for exit interviews, or anything else for that matter, unless a patient was going into the hospital within the next 24 hours. So any exit interviews or appointments would be on the doctor's dime. Nice.

My first OLTERMS shot was originally scheduled for the Friday after Thanksgiving, but the doc's office was closed that day and I was to be out of town anyway. We scheduled it for 12/19, so I'll keep my appointment and see what we can see. I have no clue what I'll do, but the CRABs have no appeal to me whatever. I need to get off my ass and start working out again and get out of my office desk chair more than I do, so that's a good place to start. Guess we'll see what else is out there that I might fit into. Haven't had a shot in nearly a year now, so maybe I can squeak in somewhere.

I'll let you guys know what I decide and I will definitely keep checking in. Though I've been absent, you have all been on my mind a lot lately and so I'm around in spirit if not in virtual body and am always eager to read what's going on with all of you.

Hang in there everybody!

<sigh>
:?

x,
patrick
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Postby patrickm » Fri Dec 05, 2008 1:31 pm

IHaveMS-com wrote:The people in the IIb trial are now in a one year extension study. I assume it will be renewed after that as long as the company has money. As for me, my study is being closed out at the end of the year....

I have come out of retirement only to say goodbye and wish everyone the best in the extension study.


When Tim wrote this, I found it interesting, but didn't say anything at the time. Because it was obvious he was leaving and wouldn't be back, asking WHY they were closing out his study didn't really seem to have much point. But I was wondering why they were closing out his study and what that meant for him. Now the why part seems obvious as a cost cutting measure.

And it turns out he was right on about the money thing! :wink:

Wonder what he's doing about his MS?
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Postby Lars » Fri Dec 05, 2008 4:58 pm

Patrick,
I agree that we as participants should have seen this coming and it was my biggest question to my coordinator. I absolutely did not want to continue if there was a chance of termination due to financial restraints. My coordinator talked to Opexa and was assured that there WAS money to continue, therefore, I was assured as well. I refuse to believe Opexa had no prior knowledge before the studies termination day. A fair and honest "heads up" was in order as people signed up for OLTERM, especially those who did so after the bad news of September. I suppose some awareness from Opexa that we are fighting a debilitating battle and not just a financial spread sheet would make me feel less of a lab rat.
I remember a lot of angst toward one particular forum contributor because it was felt he withheld information during the trial, I guess I don't see the difference.
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Postby patrickm » Sat Dec 06, 2008 7:13 am

In the business world, if you say you might be going out of business, it becomes a self-fulfilling prophecy. Same reason people won't buy cars from a bankrupt automaker. So if Opexa thought they had a shot at getting financing, then saying that they might go out of business would kill any hope. Who would loan them money if they're saying that? It's just not practical. I sure wouldn't.

So their best shot at keeping OLTERMS going, and all of us in the trial, was to do their best to obtain more cash. I've gotta believe that the financial sector meltdown doomed them. May have been hard anyway with the poor top line data, but as my doc said, there was more meat there than just the top line data. But from the perspective of somebody looking to speculate on an investment, which is all venture capital is, giving it to somebody who says that they will be closing if they don't get it would seem unrealistic, and in the face of an economic depression downright crazy

They drew the line when they had to draw the line. I guess I don't understand what anybody would have had them do differently on that front except show better study results AND come up with more financing. As long as they had cash, they kept going and continued to pitch their company to obtain more cash, which has been a consistent action by them, and any startup without a product or service bringing income, from the beginning. And they kept doing that until they couldn't obtain more, and then they had to wrap up. Should they have wrapped up before they ran out, but also before they knew for sure that they couldn't get more? That just doesn't make sense to me. There is always hope until there isn't hope, and then you have to face reality.

And if they tell just Patient X, "Psst, hey X, you may not want to go forward in the extension because we may not have the funding to continue," then that's as good as quitting because then it's all over the internet, and even the rumor that somebody may go under is enough to make the funding dry up and thus the end becomes inevitable.

I don't say any of this because I'm NOT bummed. Of COURSE I'm bummed. I'm POd for me. I'm POd for you, Lars, because I know how much of a struggle this was for you for the last 18 months or so. I'm bummed for all of us. I'm bummed out for all the people who might benefit from Tovaxin, because there DOES seem to be something going on with it. There are success stories behind this drug besides enigmatic people named Tim.

Two totally separate things. My feelings about it crashing are very much separate from my view of the reality of the business. They suspended the diabetes and rheumatoid arthritis development to concentrate on ours. Things were tight. Things got tighter. Then the economy and financial sector got super, once a century, F'd. And we are all victims.

Sucks hard. And I'm sorry for all of us.

I'm sorry that this has screwed you in more ways than one, Lars. I really am. AND believe me when I say I understand why you feel that way. And furthermore, if I'd had your experience for the last 18 months, it's likely that I would feel exactly the same. But to say that somebody who voluntarily signs up for an extremely restrictive trial and then acts in a way that purposefully screws that trial just to cover his own ass, who signs the same forms we all did saying that he understands the consequences, and then skews data that potentially stands to help tens of thousands of people because he's too scared to live up to his word—and thus shouldn't have been in the trial in the first place, vs. a company doing what appears from the outside to be the best that they can to keep their baby afloat under uniquely crappy circumstances, I'm sorry but I don't really see those as congruent. I just don't.

And again, I DO think that this sucks for all of us, and the way it played out has hurt many of us in myriad ways. I'm just not sure what they could or should have done differently while trying to stay afloat. The only info I have is the info that we all have.

I think pulling the plug could have been handled differently, in a more compassionate manner that acknowledges that while we are all voluntary lab rats, we are also people with a really shitty disease. I'm pretty pissed about that. How about pulling the plug even a day earlier so that they had enough cash for exit interviews where the docs are paid to tell us how we are doing and what our future options are? That would have been a nice acknowledgement of what we have given to this study and the human thing to do.

Hope this makes my viewpoint a little more clear.

Jesus Christ I'm wordy.
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Postby Loobie » Sat Dec 06, 2008 8:29 am

I agree with a lot of your take on this. Even though we are in hard economic times, if they'd have shown the results, then the money would be there. That's just how it works. The people with the money have taken their eyes off this and put them on to something that looks more promising. These venture capitalists just don't stay around very long by backing something that isn't showing results that can be shown on a spreadsheet. So I don't think compassion is part of their equation. It would be nice, but they just don't work that way. If their money isn't going to make more money, they're out of there. If it looks like it will make them money, then they will keep throwing it at it.

One thing that hit me so hard about this stuff not working was that I had hopes that this might be the one that could allow us to gain some recovery. Just stopping progression seemed, obviously, less appealling than getting some function back. Now that I'm back on a drug that only touts progression stopping I must tell you I had to recalibrate. So now I'm looking for things to just stay the same for a while and it's absolutely not as positive of a hopeful feeling as hoping for some regaining of lost function. So I'm not as hopeful for Tysabri as I was Tovaxin by any measure, and that's kind of a downer. Looking forward to something like getting your health back is a whole different emotional dynamic than just looking forward to staying the same. But I'll sure as hell take that over the last couple of years trip down the slide that I was taking during the trial.

I don't feel like I'm expressing that very well. I guess it just comes down to the fact that losing a bit of hope to be able to do more of what you enjoy just sucks. It takes a little bit of optimism out of your outlook and just adds another layer of dissapointment as we all try to figure out how to accept the fact that we don't have many options for treatment, and those that we do have, are marginal and not to be counted on unless you went to set yourself up. I don't know how to NOT set myself up because I think we all will always hope that whatever we are putting into ourselves will help. But one lesson I hope I've learned for this is that old cliche about MS; hope for the best, but prepare for the worst rings true about now. I guess there's a reason that's a cliche.
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Postby Lyon » Sat Dec 06, 2008 9:46 am

oo
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Postby Lars » Sun Dec 07, 2008 9:09 am

My last word on the subject; There is a valid reason that many choose the natural path in all this. One only has to turn on the TV for 30 seconds to see Pharmas hocking crap we don't need or understand. This is a business about dollars not cures. I think my avoidance of the Crab regime has as much to do with that knowledge as it does to do with the fact that they don't work. Sorry if my expectations of people leans more to the humanitarian side and less to the acceptance of those in it for the cash. I think I'll go see my Naturopathic tomorrow.
Be Well All,
Lars
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crazy question

Postby JanethePain » Sun Dec 07, 2008 10:15 am

Okay, kids, if I "read" crazy, it's because I'm coming down (I'm pretty sure) with a major sinus infection and am so oxygen-deprived with this congestion I hardly know what I'm doing.

So--some questions, if you will:

1) For those who got the real thing during the trial: if you all can remember, how many days were you "off-therapy" between finishing your last conventional meds and getting your first jab of Tovaxin? I went about 13 months, plus or minus a few days.

2) How long did you have to wait between your Shot # 5 until OLTERMS kicked in and you got re-juiced? That came down to one year (exactly) for me.

3) For you Placebo Kids: how long were you off-therapy between last meds and REAL stuff in OLTERMS?

I guess this is what I'm trying (poorly) to get across: would you be willing to be off therapy for six months to a year while I (and any other strident other lab rats) start asking some questions and raising some cane and trying to find some leads really worth pursuing?

For what it's worth, I got onto that US Government clinical trial site and copied the locales nationwide that participated in our Tovaxin stuff. There isn't any fine detail of contact info--that's my next step, you see.

What I hope to do this week is shoot out snail mails and e-mails to Study Site docs and coordinators asking them if they'd like to add their $0.02 to the plan of getting as many of the 150 of us on board to make the collective pitch to the BIG pharmas.

Hope this is clear. My Sucrets are calling! :cry:
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Postby patrickm » Sun Dec 07, 2008 10:31 am

Lars wrote:My last word on the subject; There is a valid reason that many choose the natural path in all this. One only has to turn on the TV for 30 seconds to see Pharmas hocking crap we don't need or understand. This is a business about dollars not cures. I think my avoidance of the Crab regime has as much to do with that knowledge as it does to do with the fact that they don't work. Sorry if my expectations of people leans more to the humanitarian side and less to the acceptance of those in it for the cash. I think I'll go see my Naturopathic tomorrow.
Be Well All,
Lars


Hey Lars,
I think we may be more in agreement than you believe. I wish things were that way, but I guess I don't expect it. More of a realist with my expectations, but not my hopes. But a business is a business and Opexa has been playing in the capitalist gladiator arena.

I'm going to do my best to avoid the CRABs as well. Please keep us up to date on what you end up doing and I'll do the same. Good luck and be well, my friend!
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Postby patrickm » Sun Dec 07, 2008 10:36 am

Jane-
Tovaxin was my first MS treatment and I haven't had a shot since last December sometime. I've waited nearly a year. I'm going to explore other avenues with my doc in 2 weeks and then evaluate what's out there. I can't say that I wouldn't wait, but I also don't know what the other options are for me right now, so I can't say that I would either. Is that a quadruple negative?

Sorry about your cold! Hope it behaves itself as much as possible.
p
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Postby Lyon » Sun Dec 07, 2008 11:50 am

oo
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