Opexa Announces Top-Line Results from Phase IIb Trial

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby TWG » Sat Sep 20, 2008 11:47 am

It appear Opexa went to do another presentation after the first. Check it out at....

http://www.youtube.com/watch?v=Jt8Q7Fsa_Vs
Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Postby flipflopper » Sat Sep 20, 2008 4:06 pm

TWG, your post cracked me up! Thank you for that.
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Postby alexisss » Sat Sep 20, 2008 4:36 pm

Doesn't anyone think that the words used by Tim (son of the ex CEO of PharmaFrontier) to create hype around this vaccine is unethical? Also, don't his parents own (or perhaps owned) many shares in Opexa? I am wondering why nobody is bringing this up. I have followed everything he has written on this site, on other sites, and on his own website from the beginning. He wrote intelligently but purposely made everyone believe that this vaccine had immense potential. There is no excuse for not writing over and over again that his own experience might not apply to everyone (or to most) unless you had some pretty good knowledge from "insiders" (which he had) that this really was an amazing product. Perhaps if his posts were not so intelligently composed and he had a very very very low IQ, I would not bring it up. It's not the case. I don't think it was right. I should say that a few months ago, he had a thread that was called something like "results may vary". However, I think it was deceitful to not mention this from the beginning (and more often). Again, I think all the words and the impressions he conveyed when talking about this vaccine are unethical



Edited : I apologize. I just wrote what is above right after seeing the results and maybe I shouldn’t have.
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Postby Lyon » Sat Sep 20, 2008 5:13 pm

..
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Postby JanethePain » Sat Sep 20, 2008 7:56 pm

alexisss wrote: Doesn't anyone think that the words used by Tim (son of the ex CEO of PharmaFrontier) to create hype around this vaccine is unethical?

I hope you chill out--considerably--before you think of posting again in a similar vein. Now to answer your question: no, I don't. To add my own comment, I think you're way out of line--for one thing, Tim's dad is/was a bio-statistician who put his education/training to work in researching "next" options for his son when Tim failed to respond to the then-available ABCs.

alexisss wrote: Also, don't his parents own (or perhaps owned) many shares in Opexa?

Yes but so do a lot of people. I do, too--but not "many" by a long shot. But whether one owns one or "lots," we've all taken a hosing in the current economy.

alexisss wrote: I am wondering why nobody is bringing this up. I have followed everything he has written on this site, on other sites, and on his own website from the beginning. He wrote intelligently but purposely made everyone believe that this vaccine had immense potential.

He and his brothers logged Tim's experiences--in great detail. They also linked readers to every necessary component on the Opexa website in order for us to get more detailed information.

alexisss wrote: There is no excuse for not writing over and over again that his own experience might not apply to everyone (or to most) unless you had some pretty good knowledge from "insiders" (which he had) that this really was an amazing product.

I have an Outlook folder of e-mail correspondence from Tim dating back to '05 and in each and every query/problem I brought up, Tim emphatically stated that his experience could very possibly be unique to his condition.

alexisss wrote: ... Again, I think all the words and the impressions he conveyed when talking about this vaccine are unethical

Well, as I see it, you have a couple of choices. 1) sever your ties with Opexa and file a complaint with the FDA and the moderators of this website 2) GROW UP AND DEAL WITH THIS DISAPPOINTMENT AND STICK WITH YOUR PROTOCOL.

That's ALL it is, too--a disappointment--NOT a conspiracy on the part of Opexa or Tim and his family. We're still in the very early stages of the process of getting this VERY promising therapy on the market. I daresay that by the time Tovaxin gets FDA approval, the gang of us who make it to the finish line will have a war wound or three to show the grand-kiddies.
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Postby JanethePain » Sat Sep 20, 2008 7:58 pm

Lyon wrote:... I personally consider Tim to have been a great help, with it in mind that people entering other clinical trials have to go about it with a general lack of knowledge... I'm still convinced that Tim didn't pass along any information that he didn't believe in. Bob


I agree! YES!
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Postby Ant148 » Sun Sep 21, 2008 4:05 am

am i stupid or are these results not as bad as a lot of folks here made them out to be? seems to me that everyone was severely disappointed because they expected Tim's original results extrapolated onto a varied field of 150 MS patients with a statistical abberation to boot.

personally, i'm still very excited about finally receiving the real vaccine (hopefully some time soon. did i understand correctly that Opexa is back up and running?) but i am worried about Opexa's solvency.

however, wasn't there a recent aticle about them confirming several million dollars of new funding so they can keep going? is that at risk now because of these recent results?
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Postby patrickm » Sun Sep 21, 2008 5:57 am

Ant148:
When the results show that they're statistically no better than placebo, then I'm not sure it's possible to overreact too terribly much. And going from a 92% reduction in ARR down to 30 something and in line with CRABs is quite the drag. So I guess calling it an overreaction is in the eye of the beholder.

The added bummer is their financial solvency and I don't think we have any way of knowing what will come on that front, but with less than sparkling top line data, the prospects for future funding, esp. in the current unbelievably bad economic climate, would seem rather dim.

I am by nature a pessimistic realist though I salute your unflagging optimism.

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To alexisss:
On Tim, it seems to me that everything I've read from him in the last two years has included a disclaimer and he's been exceedingly helpful. It is one guy's story in a trial, which is a very small sample. I'm very disappointed that the current results don't mirror the Phase I results, but that's why they have Phase II and III trials, isn't it? I'm a big boy and while I'm quite bummed that they didn't show better results, I made up my own mind based on everything I could gather at the time I was seeking my first treatment options. I'd signed on before I found his information. I don't blame Tim for sharing his experiences and insight. It has been a comfort to me.

If you feel otherwise, then I suggest you file a complaint with SEC and the moderators here, and speak with your therapist.

---------

In both cases, I'm not in the business of telling others how to think or feel, so follow your own bliss.
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Postby CureOrBust » Sun Sep 21, 2008 6:38 am

to be honest, I was more more wooed by the statistical results from previous studies than by anything Tim said.
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Postby Lyon » Sun Sep 21, 2008 7:42 am

..
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Postby Lars » Sun Sep 21, 2008 8:17 am

Adding my 2 cents, I agree with Cure. I joined this trial because of Opexa's earlier data. I have NO idea how results can go from over 90% lesion reduction to what we have now witnessed. I am also having a bit of trouble with the data that links more lesions with less relapse?????? If that is true it compromises the original scientific theory of Tovaxin. I have plenty of lesions already thank you very much. If less relapse is Tovaxins big selling point now please realize, that data has to be questioned. No one wanted to admit they were having issues for fear of being suspended from the trial, I'm not saying patients were holding back information, they were just toughing it out to continue towards vaccine. Furthermore, my goal was never a "safe" route, so Operas giddiness with the safety of Tovaxin means nothing to me, water is safe but I don't think it cures MS. As to Tim's role, he has been extremely helpful and hopeful, he is also the only person I have ever heard of that Tovaxin has worked for. Time to have a heart to heart with family, friends and Neurologists.
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Postby Loobie » Sun Sep 21, 2008 9:46 am

Hang in there Lars. You are not someone I envision sitting around wanting to see what to do next. You could always try to get to Chicago with me! I didn't qualify for the Campath trial because of Tovaxin, so I'm going to try for Revimmune in Chicago since JH is full for a while. I agree that Tim was solid on his information sharing. He always answered my emails and never looked at a question as not worthy of attention. Granted I didn't see what he has obviously seen, but with this goofy disease, we all know what works for one may do nothing for another.

Bob, your talk about the using people early on is something I agree with big time. I was singing the praises of Avonex early on when I could really have probably been just as fine on nothing. I think, with some obvious exceptions, that the 'usual' first 5 years tend to be mild. No way for me to know if I would have been fine without the Avonex, but I just know how I feel.
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Postby av8rgirl » Sun Sep 21, 2008 9:57 am

thanks Jane, as usual, you hit the nail on the head!
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Postby Lars » Sun Sep 21, 2008 10:11 am

Lew,
Thanks. So, Campath was not an option because of Tovaxin? I wonder if one knew for sure they were not receiving Tovaxin if it would make a difference. I have been convinced that I was I was a placebo patient but now I'm not so sure. I just got my MRI report from a "dummy" test at my clinic and it is LOADED with new activity. Maybe I was getting Tovaxin???? Interesting few days!
Lars




"You must do the thing you think you cannot do".

(I've about had it with Eleanor Roosevelt)
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Postby Loobie » Sun Sep 21, 2008 3:25 pm

Well for the new trial with Campath and Rebif (no one gets nothing) I was told I was not eligible because of the Tovaxin. They are supposed to tell me the 'wash out period' at my steroid infusion on Tuesday. They actually checked into it the day I received my 5th tovaxin dose. I was explaining how nonplussed I was w/ tovaxin and we talked about that trial. My coordinator had a call in about it even before I left, and I had an email in my inbox the next morning telling me that the recent tovaxin rendered me ineligible. I will find out the period you have to wait and post it.
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