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This is quite surprising and a little suspicious ????




September 08, 2009 07:00 AM Eastern Daylight Time
Opexa Reports Additional Favorable Data with Tovaxin® for Multiple Sclerosis

Further Analysis of TERMS Phase IIb Data Shows That 85% of Patients Treated with Tovaxin Responded Favorably, 16 % Showing Actual and Sustained Improvement in Disability

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a personalized T-cell immunotherapy for multiple sclerosis (MS), today announced results from further analysis of the double-blind, placebo-controlled, 52-week Phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS). This analysis evaluated patients with an annualized relapse rate of one or greater at study entry (ARR≥1). More than 83% of the Tovaxin-treated group (n=85) remained relapse free at one year and the annualized relapse rate after treatment decreased to 0.20, a 42% reduction compared to placebo.

The results of this expanded analysis confirm those found in the previously-reported per-protocol analysis of patients in the TERMS study with ARR>1. This post-hoc analysis which represents 86% of the total patient population in the TERMS study was conducted to evaluate Tovaxin treatment among study patients with the same baseline disease activity that is being targeted for inclusion in the forthcoming Phase IIb study. Along with a marked reduction in relapses, 73% of the Tovaxin-treated patients with ARR≥1 showed stabilization or improvement in MS disability, including 16.5% with a sustained improvement in the Expanded Disability Status Scale (EDSS) of at least one full point. On MRI, the Tovaxin-treated group also demonstrated a reduction in brain atrophy and fewer inflammatory brain lesions that progressed to “black holes,” as compared to the placebo-treated group. Treatment with Tovaxin was well tolerated, with no serious adverse events reported in any Tovaxin-treated patient.

“The expanded analysis represents the MS patient population with active relapsing-remitting disease planned for recruitment into the next Phase IIb trial of Tovaxin,” stated Dawn McGuire, MD, a board certified neurologist and a member of Opexa’s Clinical Advisory Board. “Clinical benefits include not only reduction in relapses, but a surprising reversal of disability in over 16% of Tovaxin-treated patients. Along with MRI data suggesting a reduction in neuronal cell loss, these results raise the possibility that Tovaxin-treatment may have neuroprotective as well as disease-modifying effects. Tovaxin’s favorable safety profile and these early efficacy signals strongly support moving forward with a confirmatory Phase IIb trial.”

Tovaxin is a personalized T-cell vaccine based on a patient’s individual immunologic profile. Detailed immunology data analysis from the TERMS trial indicate that Tovaxin can successfully induce changes in T-cell reactivity to all three targeted myelin antigens implicated in the autoimmune attacks causing neurologic damage in MS. These changes appear epitope-specific, are sustained for 6 months or more, and match each patient's Tovaxin formulation. Tovaxin is not broadly immunosuppressive, an important feature of its favorable safety profile.

“From an immunology perspective, the data generated thus far from the TERMS trial, from thousands of patient samples, appear to correlate nicely with the putative mechanism of action for Tovaxin. While additional analyses are still in progress, we are also seeing early associations between depletion of myelin reactive T-cells and favorable clinical outcomes,” commented Dr. McGuire.

About Opexa

Not suspicious to me. Their problems were that too many un-sick people like me were randomized into vaccine group. So they take a subset of that with ARR≥1 and they're in business. Another way to parse the data and they're doing it on the sickest of their patients.

So to get into the next study, we all need to relapse. Of course it is a huge assumption that they'd even let us into the next round. Since nobody has any idea how long this stuff is good for, we would probably skew that study as well.

Had a long talk with my neuro two weeks ago and I am now on Copaxone. I am also relapse free for nearly 3 years and eagerly awaiting the oral meds next year. Relevant because we discussed Tovaxin at some length. He had not heard from them about any next steps to be taken by the company so this looks to be their first word about their next step. he's also at a huge conference in Germany all week so will be interesting to hear what comes of it.

As it stands, I don't see how they have the cash to move forward with another phase IIb since their deal with Novartis looks to be about as back-loaded as the contracts for the 4 most overpaid Cubs players.

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Bob,
Why would any of us submit to further testing with no carrot? Most don't respond for the good of science. I'm sure a few would. I'm not at all sure I'd be one of them though.

Give me my vaccine currently sitting in a cooler in The Woodlands and then we're talking!

I think the proof is in the results as posted. The stuff works. Whether it worked specifically in any of our cases is always ephemeral, but when spread out of the lot of us, the stuff works and I'd sign up for more of it in a heartbeat, esp. when considering the crappy, CRAPPY choices with which we are all faced at this juncture.

Glad your wifey is still doing well!

Even if you had money to invest, I'm not sure anybody would have recommended Opexa as anything but high risk at any point in the last 3 years...

And for the most part, I guess I'd say you should be glad you didn't or you would have lost it, and not just on Opexa!

p

I'm more than willing to jump back into the program.

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Jane the Pain

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I can't see how with their still exceedingly limited resourced and debt that they'd find it feasible to go back and find a way to get us back in. We've all been off doing too many non-study type things. Add in their stated desire for a new IIb with better crafted endpoints, and it just seems like they'd throw their cash and people at that and we would be left behind, at least for now.

I hope I'm wrong, cuz I'd jump back on the stuff like white on rice. Stuff works.
p

Hey Patrick,
Good to talk with you after a somewhat non-self imposed break. 3 years relapse free? I would just continue what you have been doing! I am, at this juncture a "huge" LDN fan. 5 months and better than I have been in years. I would submit myself to the Tovaxin trial if it were presented to me but I have refused all other options because of my success with LDN. My thinking is LDN for MS and Medical Marijuana for MS related pain, I've had quite enough of prescription meds. I am still not sure about the future of Tovaxin but I have been happy to get back to living rather than focusing on my MS. As a side bar, I haven't checked in for a long time and have spent my time working, camping, mountain climbing, fly fishing, and basically enjoying life before the next MS screw up I would suggest the same to everyone who is capable. Life is short, do what you can when you can!
Be Well, be really well,
Lars

D00d! You're down from the mountains? How is your beard going? Are you talking to squirrels yet and are they talking back? In English?

I am quite jealous actually. Quite.

And very good advice.

I've spent the time caring for a mom with pancreatic cancer and trying to keep my businesses and home life afloat, with moderate success at best on all fronts. Boy needs a vacation!

Thanks for the advice, and like you said, keep doing whatever it is that you are doing. Something is working. Hang in there amigo!
p

Check this out: <shortened url> Sounds. encouraging!

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Diagnosed with MS in Feb. 14 2000! Was a Tovaxin guinea pig.

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Seriously, what's up with that stock these last few days?!?!?!?!!?

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Jane the Pain