Opexa Therapeutics Announcement:

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Opexa Therapeutics Announcement:

Postby TWG » Wed Jan 05, 2011 9:10 am

Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Postby Lyon » Wed Jan 05, 2011 1:37 pm

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more......

Postby TWG » Wed Jan 05, 2011 2:54 pm

Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.
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Postby Lyon » Wed Jan 05, 2011 3:55 pm

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Postby JanethePain » Thu Jan 06, 2011 12:25 pm

This is GREAT news! Let's hope we can all join up again soon and get this show back on the road!

As for flares, to the best of my knowledge, I hadn't had ANY until a bit before T'gobbling; now I have the Mother of All Numb Thumbs and a tingly/doggoned sore hand and arm; typical of my pattern, though, I'm on the way "back" and the tinglies are gone from the upper arm and elbow and working their way down.

Numb Thumb drives my CRAZY. Good thing I'm not left-handed; I would have been 100% useless over the holidays.

Okay and now for the BIG question... how bad were you over the holidays? Some brats gave me those cherry-chocolate-candied cherries from Harry & David and I now owe said brats about 30 pounds.

;-)

Looks like January is starting off nicely. :-)
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Postby Lyon » Thu Jan 06, 2011 1:29 pm

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So I zipped off an e-mail to Opexa yesterday... :-)

Postby JanethePain » Fri Jan 07, 2011 11:56 am

... and here's the reply I got! This is all a copy to a Word document because I forgot how to paste a mail into the reply format here!

:-)

From: Jaye Thompson [jthompson@opexatherapeutics.com]
To: (Me the Pain)
Subject: Re: The January 5th announcement

Dear Jane,

Thank you for your continued interest in Opexa’s product, Tovaxin, and for your patience! The company continues to develop the product because we know that many people are seeking therapy alternatives that may be met by our product. It has been a long and difficult path so we are very happy to be moving back to the clinic.

The company is currently in the planning stage for the next clinical study of Tovaxin to gather more evidence regarding the product’s safety and efficacy. Please watch our web site, www.opexatherapeutics.com, and www.clinicaltrials.gov for details about the study’s initiation, site locations and entry criteria for our next clinical trial. As that information becomes available, we will publish to those two sources. However, Opexa always encourages that patients seek the advice of a neurologist and consider all treatment options.

Let me know if you have any questions or I can help in any way.

Best Wishes,
Jaye

-------------------------------------------------------------------
Jaye Thompson, Ph.D.
Senior Vice President
Clinical Development and Regulatory Affairs
Opexa Therapeutics, Inc.
2635 Technology Forest Blvd.
The Woodlands, Texas 77381
Phone 281.719.3421
Fax 281.872.8585
Cell 713.410.2257
jthompson@opexatherapeutics.com
www.opexatherapeutics.com
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Postby Frank » Tue Jan 11, 2011 8:50 am

Does anyone know how they are getting funding for the phase-III trial.
I mean after the IIb trial there was much disappointment and the therapeutic concept itself was taken to question. What changed since then? Did they change the therapeutic concept in some way, do the only recruit a certain typ of patients for the phase-III as opposed to the IIb trial? And again who is giving them the money for a very costly (Phase-III is reported to be a multi 100million US$ project) after a "failed" Phase-IIb trial!?

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby JanethePain » Tue Jan 11, 2011 12:20 pm

Frank wrote:Does anyone know how they are getting funding for the phase-III trial.
I mean after the IIb trial there was much disappointment and the therapeutic concept itself was taken to question. What changed since then? Did they change the therapeutic concept in some way, do the only recruit a certain typ of patients for the phase-III as opposed to the IIb trial? And again who is giving them the money for a very costly (Phase-III is reported to be a multi 100million US$ project) after a "failed" Phase-IIb trial!?

--Frank


Phase II-b didn't "fail." The cash dried up after the Moron Brigade assed around with a mid-phase report (it doesn't take a rocket scientist to know that Money People never read beyond the first sentence). So with the positive results buried in the final paragraphs, OF COURSE it was inevitable that support would dry up.

If the therapeutic concept had been a total bust, Phase I results would have halted even the recruitment for our Phase II. And Phase I demonstrated some extremely impressive data.

Yip, Phase III is going to cost a boat-load of cash, no doubt about it. I have no idea how many Opexa staff are figured into the treatment of one patient but if Phase III follows the typical 5,000-person protocol, this might be a good time to apply for lab tech job if you live in the Houston area. :-)

There will be so many more sites, too, and that's a cash outlay. Lotsa bucks.

Now about the "inclusion protocol," last I heard Phase III will cut across the "ambulatory" restriction on Phase II. Since it wasn't an exclusion during Phase I, I kinda wondered why it was so during our phase.

Let's see. Oh yes, the rumor also hinted that "Progressive" patients would be included as well as us "Remitting/Relapsing."

As far as I can guess, the only exclusion will be the failure to pop up those Myelin Reactive T-cells.

Which can be only good news for all of us.

However, I do intend to request the firing of whatever moron wrote up that damned damaging report.

;-)
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Postby Frank » Tue Jan 11, 2011 12:32 pm

Hi JanethePain,

as far as I know the report about the phase-IIb trial said that there was no statistically significant success in the Tovaxin group. This was a report that was released after the trial was completed, wasnt it?
What are the positive results mentioned in the last paragraph that you refer to?

Thanks!
--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby Lyon » Tue Jan 11, 2011 2:11 pm

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Postby Frank » Fri Jan 14, 2011 11:06 pm

Hi Bob,

do you have any suggestions about the questions I raised in my two prior posts?

Thanks
--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby Lyon » Sat Jan 15, 2011 11:38 am

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Postby av8rgirl » Sun Feb 13, 2011 7:35 pm

I am glad you got a response from Opexa Jane! I tried to get information from the clinical trial site and oh gee, got nothing! Is that a surprise? Oh not! Considering I didn't even get an exit letter from them! I have been on a roller coaster ever since my exit from the trial in 2009 and am now on monthly pulse steriods I certainly don't expect any sympathy from that group!

I do hope that we who have helped the statistics show favorably will get first crack at the Phase III trial but who knows!

Anxiously awaiting the next phase ----
“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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