Its over

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Its over

Postby Sweetyhide » Mon Nov 24, 2008 12:47 pm

I just got a call from my coordinator and Opexa is suspending Tovaxin.
Thats all I know at this point.
Will have to research what my next adventure will be.

Its been a wild ride, for sure!
~Sweety
Peace, Love and Potato Salad
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Postby HEC » Mon Nov 24, 2008 1:23 pm

I just got the same call. Holy crap. No more funding, no more study, cancel all appointments, etc. No scoop as to whether or not there will be follow up down the road, but I will keep pressing for details.
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Postby ssmme » Mon Nov 24, 2008 1:55 pm

Well crap. What do I do now.
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Postby Aggie03 » Mon Nov 24, 2008 2:56 pm

I got the call as well. I had my fist shots of the next phase scheduled for next Tuesday. Where do I go from here????

Did anyone get the MRI results? I atleast want to know that.
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Postby Lyon » Mon Nov 24, 2008 3:02 pm

oo
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Form 8-K for OPEXA THERAPEUTICS, INC.

Postby notasperfectasyou » Mon Nov 24, 2008 3:54 pm

Form 8-K for OPEXA THERAPEUTICS, INC.


--------------------------------------------------------------------------------

24-Nov-2008

Costs Associated with Exit or Disposal Activities



Item 2.05. Costs Associated with Exit or Disposal Activities
On November 21, 2008, the board of directors of Opexa Therapeutics (the "Company") approved a restructuring plan to terminate the one-year open label extension of the TERMS Phase IIb Clinical Trial of Tovaxin� therapy for multiple sclerosis (OLTERMS). The trial was enrolled with patients that had previously completed one year in the TERMS, Tovaxin Phase IIb multi-center, randomized, double blind, placebo-controlled trial. The Company is terminating OLTERMS in order to focus all of its financial resources on completing clinical data analysis, future clinical trial planning and seeking a development partner for Tovaxin. As a result of these circumstances, the Company will immediately reduce its staff of 29 to approximately 10 people. Personnel-related restructuring charges of approximately $120,000 are expected to be incurred in the fourth quarter of 2008. Employees directly affected by the restructuring plan will be provided with severance payments and continuation of benefits. The Company is exploring its strategic alternatives, including a clinical development partnership, merger with or acquisition by another company, further restructuring of the Company, or sale of the Company's assets and liquidation of the Company.
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Postby Lyon » Mon Nov 24, 2008 4:06 pm

oo
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Postby av8rgirl » Mon Nov 24, 2008 5:28 pm

I just got called as well. I asked all sorts of questions and really got no answers. The person that called me was someone I had never heard of at the site - neutral party???

Anyway, the response was no money. I won't even get a termination appt as I live too far away. I did ask for one as I have never seen any of my final tests/MRI. I told the coordinator that I would really like a "debrief/termination" appt if at all possible. She said she would let me know.

In the meantime, I had a 2 1/2 hour full spine MRI last Wednesday and am awaiting those results. At least now I don't have to get the trial docs permission any longer for med changes or IVSM for this flare I believe I am having!

Now I have to decide on a therapy...
“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 patientx » Mon Nov 24, 2008 6:27 pm

I feel badly for all those involved in the trial. Despite the negative reaction to their published results, it seems this was a promising treatment. Hopefully they can restructure and continue with a Phase III trial.

What gets me is that Opexa is talking about dollar amounts in the $100,00 dollar range, while our crooked government can give billions to these stupid wall street firms that made bad investments. It just make me shake my head in disgust.
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Postby HEC » Mon Nov 24, 2008 6:30 pm

I was able to get an appt on Monday afternoon to see my neuro for a visit unrelated to the study to make a treatment game plan since I don't have the luxury of being in denial until next June if I had continued to be MRTC negative. I had to go in the this afternoon for a blood draw for regular lab work to compare this year's to last year's, and while I was there, I got to see the trial coordinator who is heartsick and so frustrated for all of us. I keep reminding myself I was lucky to get the vaccine last year, but then I get furious thinking about the peeps who didn't get it last year and who were finally getting it now. That is the worst. The coordinator said that for those people who have had injections recently, they will be "monitored" for 30 days post injection to report anything amiss, but that's it. Two people in the Seattle trial recently had their procurements and now nothing, and no way to get at the vaccine that's already been made up. I didn't think to ask if they would release any of the recent MRI info - that's a good question to ask - I'll inquire about that on Monday at my neuro visit. Rat bastards.
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Postby Loobie » Mon Nov 24, 2008 6:32 pm

This does suck. One option that I took was Tysabri. I ain't saying anything yet, but I do notice differences. I guess one good thing about Tovaxin was that the "wash out" period is not long (I really don't know if there even is one) and it's not contraindicated for any of the MAB's. I will say though if I thought Tovaxin was working for me, which I obviously didn't, I'd be highly upset right now. I got pissed enough when I decided to get out of the trial. I guess not at any one person in particular, unless we find out that David McWilliams was paying himself like 10 mil or something absurd for heading a before approved drug company.
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Postby Lyon » Mon Nov 24, 2008 7:07 pm

oo
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Postby Loobie » Tue Nov 25, 2008 5:54 am

Yes, I have received one infusion and have my next one scheduled for 12/5. No side effects but mild flushing for about 15 minutes.
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Postby av8rgirl » Tue Nov 25, 2008 7:54 am

Loobie wrote:Yes, I have received one infusion and have my next one scheduled for 12/5. No side effects but mild flushing for about 15 minutes.

Good luck with the Ty! I hope you do well on it.

I am still in shock over this termination...
“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 » Tue Nov 25, 2008 8:41 am

Hi All,
Wow, this was shitty breakfast news. I have NOT gotten the call. I suppose it's stupid to ask "are you sure"?
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