This Is MS Multiple Sclerosis Knowledge & Support Community

- ARR for Tovaxin-treated patients was 0.214 as compared to 0.339 for placebo-treated patients. Consistent with ARRs seen in previously conducted clinical trials for Tovaxin, this result is at the lower end of the spectrum of documented relapse rates demonstrated in controlled two-year clinical studies of currently marketed products (range from 0.2 to 0.9).

- For patients who had an ARR > 1 in the year prior to the study, Tovaxin demonstrated a 55 percent reduction in ARR as compared to placebo.

- Tovaxin was safe and well tolerated with no serious adverse events related to Tovaxin treatment. The most common adverse event was injection site irritation.

----****** Only 18 patients (12 percent) withdrew from the study prior to completion. The dropout percentage was identical for the Tovaxin and placebo arms of the study, providing further evidence of Tovaxin's excellent safety and tolerability.

"We are especially pleased with the TERMS study's ARR results, as this represents the most common efficacy endpoint evaluated by the FDA when approving MS therapeutics. Opexa expects that ARR will serve as the primary endpoint in any pivotal Phase III Tovaxin study," commented Mr. Warma.

Opexa intends to complete a comprehensive analysis of all data from the TERMS study over the next several months. Based on the TERMS study results, Opexa expects to conduct a Phase II close-out meeting with the United States Food and Drug Administration during the first half of 2009. This meeting, along with the comprehensive results of the TERMS study, will provide important guidance as Opexa plans to advance Tovaxin into Phase III development.

Additionally, Opexa is conducting a one-year, open-label extension trial of the TERMS study called OLETERMS. Approximately 90 percent of patients in the TERMS study have elected to enroll in the OLETERMS trial.


I added the ---***** next to the one statement because it's a lie. 18 people were kicked out because they didn't have the data OPXA wanted. If that is not the case prove me wrong.

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Chris

And how do you KNOW this for sure? Do you have some sort of magic crystal ball that the rest of us don't?

Aren't you on some sort of other "cure" for MS?

If you know facts, then post them. Otherwise stop spreading rumors and gossip.

av8rgirl wrote:Chris

And how do you KNOW this for sure? Do you have some sort of magic crystal ball that the rest of us don't?

Aren't you on some sort of other "cure" for MS?

If you know facts, then post them. Otherwise stop spreading rumors and gossip.

It was my understanding (admittedly a LONG time ago) that the patients at the facility in question weren't dismissed because of anything they had/didn't have or done/not done... but because of failure to stick with the protocol from staff.

I'll do my best to get a confirmation on this when I sashay in for my jabs in late October.

Ask PVNS. He wasn't surprised at all.

No clue about a cure or not. All I know is some wild stuff is happening with this whole Tovaxin thing. I never brought up anything else. Bob did not me.

2 fers at the local bar? LOL no, obviously not!

The staff at the trial facility did not fail protocol. I was dropped because OPEXA stated there were safety issues with me continuing the trial. This was after I completed the IIb trial and had already had my blood drawn for procurement for the extension study. Two weeks before the shot I was dropped. This tells me that I was on the real vaccine. Why would they drop me from the study if I was on the placebo???

I got an MRI the next week for the Johns Hopkins consultation for HiCy (Revimmune) and it showed I had seven new active lesions. You would think if OPEXA was worried about my safety they would have dropped me sooner.

That's the facts. Nothing to argue about or debate. I received HiCy from Johns Hopkins in June and I am Feeling GREAT!!!

Good luck to all of you.

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JanethePain wrote:

av8rgirl wrote:Chris

And how do you KNOW this for sure? Do you have some sort of magic crystal ball that the rest of us don't?

Aren't you on some sort of other "cure" for MS?

If you know facts, then post them. Otherwise stop spreading rumors and gossip.

It was my understanding (admittedly a LONG time ago) that the patients at the facility in question weren't dismissed because of anything they had/didn't have or done/not done... but because of failure to stick with the protocol from staff.

I'll do my best to get a confirmation on this when I sashay in for my jabs in late October.

That was my understanding as well. Protocol violation on the part of the staff. I will see what I can find out as well.

All this ranting and raving is starting to remind me of the "PML scare with Tysabri." Did someone die???? What's wrong with everyone? Did I miss something?

This is my last post on this site but I will agree with Bob.

While you guys are arguing .77 and .2's and trying to find something positive with the 150 people who just tried Tovaxin, I have something for Bob.

50 people have done Revimmune which there is no Data for. 50 of us are getting better for which there is no proof. 50 of us have FEWER lesions (yes that meanns actually healing )than before we started the trial that we report to make it look good. 50 of us have less of an EDSS to fool Bob and other Tovaxin trialer's because we feel so much better we got to lie to others to get them to do it. One of us had the disease for 22+ years and lied about how they are doing better because we have a conspiracy.

Bob you manage to talk a great talk, and really write a well versed essay, but I can talk less and make more of a point...however my grandfather taught me the only argument I will ever loose is with a fool because they can't be argued with.

I agree Bob. There is absolutely nothing to argue.

chrishasms wrote:This is my last post on this site but I will agree with Bob.

While you guys are arguing .77 and .2's and trying to find something positive with the 150 people who just tried Tovaxin, I have something for Bob.

50 people have done Revimmune which there is no Data for. 50 of us are getting better for which there is no proof. 50 of us have FEWER lesions (yes that meanns actually healing )than before we started the trial that we report to make it look good. 50 of us have less of an EDSS to fool Bob and other Tovaxin trialer's because we feel so much better we got to lie to others to get them to do it. One of us had the disease for 22+ years and lied about how they are doing better because we have a conspiracy.

Bob you manage to talk a great talk, and really write a well versed essay, but I can talk less and make more of a point...however my grandfather taught me the only argument I will ever loose is with a fool because they can't be argued with.

I agree Bob. There is absolutely nothing to argue.

Go with God. Amen.