Tovaxin results in - news not good

whoever wrote this note knows little about early phase II trials. Relapse rate is not a primary endpoint in these trials. The Tovaxin trial has many immunological markers and MRI and other endpoints being assessed.

Before stating the results are a fluke, ask yourself if you are going to give patients an incorrect impression of their therapy. To have patients pull out of a trial early, is a sure way to help hurt MS patients and make a trial have less chance of finding out if a new promising therapy will be effective.

Read the article - it says "Opexa Therapeutics Inc. said Friday its lead drug candidate aimed at treating multiple sclerosis failed to meet its main goal"

Not sure how much clearer it can be: "failed to meet its main goal."

Do you want people taking a drug that doesn't do what it is thought to do?

And "postive trend" is just what I stated - it looks like it is going the right direction, but the statistics do NOT support it.

I'm pretty sure I know what I'm talking about after following trials for 7 years, talking to the pharma companies and clinicians, going to the conferences where they present the data, etc.

But I'm happy to be educated - what's your background and precisely what did I get wrong Mr/Ms Anonymous?

What's with all the harsh anonymous comments lately? I don't mind if you disagree - but disagree with some actual content, not insults. Make your case, support it, educate us. Just saying "yoo r stoopid" is irritating. I find it hard to be polite when I am irritated.
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Art Mellor, Accelerated Cure Project for MS, art-msnews -at- acceleratedcure.com

Hi Art,

Yesterday I posted a comment about Tovaxin on another site, and was personally criticized by the first 3 commentators. I decided that I wasn't going to engage these people anymore. Tovaxin failed its phase II. The stock went from $2.40 to $0.20 in 1 hour. Further, the father of its most high-profile promoter and alleged user left a position on the BOD after Opexa obtained its phase II financing. Given all of that, the most rationale conclusion is that, at best, Tovaxin does not work, and at worst, may have been a scam.

Thank you for putting together the Accelerated Cure Project and this great website. My baby sister has SPMS, hence my strong interest in MS research.

Ed.

Ed.

Here are the facts that give rise to the appearance of impropriety, though. The theory is that you can mark the rogue T cells and train the immune system to recognize and eliminate them. Great. A clinical researcher researches the MS research field and concludes that such a MS vaccine is the most promising cure for his son with MS. He contacts the company, arranges financing for phase I, gets on the BOD and and gets his son into the clinical trial. The son experiences a fantastic recovery from aggressive MS. All of that is great.

Then phase II financing is arranged, the father pulls out of the company altogether, phase II is launched, and the phase II is a failure. No difference between tovaxin and the placebo.

If you knew that tovaxin cured your son and the research was bona fide, why are you pulling out of the company? You're in at the ground floor. Whoever has a piece of the company that cures MS will be a multi-multi-millionaire.

Moreover, how could this vaccine be pharmacologically worthless? If it cured, or substantially cured the son, 1 dosage, 1 cure, shouldn't it have worked for at least 20% of the patients? 10%?

I won't say it was a scam because I don't know for sure either way. But this has all the earmarks of other MS scams I've seen. In my line of work (commercial insurance), investors do not pull out of companies that they think are going to be successful.

Edward Hom

I was a participant of the phase IIb trial. I never would have participated in this trial just from looking at the information of previous trials of Tovaxin (the sample size was too small to draw any conclusions). But, I saw what Tim wrote pretty much on every site on the internet (it was pretty hard to miss!) The information he gave influenced my decision to join a trial that I would not have considered otherwise. I had a bad gut feeling about Tim but ms is a serious disease, the technique was interesting and, few other options were appealing to me at the time I joined the trial. I think there were improprieties in this trial

I see that Ed the investor is posting here bellyaching about losing the $1000 he had invested in Opexa! That just warms my heart as a participant in the Phase IIb Tovaxin clinical trial. I happen to be one of the people who challenged him on one of the sites he is referring to.

I did very well on Tovaxin and found out that I had received the drug and not placebo. I went from having 4 exacerbations a year on "approved" therapies to one during the trial. I have failed Betaseron, Tysabri and Copaxone as well as Beta+Methotrexate, pulse steroids, and can't do IViG because of all the allergies I have. I was lucky to be accepted into this trial so people like Ed the investor do not make me happy. He has some pretty unkind things to say, along with some other people, but he is entitled to his opinion. He wasn't on the drug, I was. Along with many others.

My take is that the trial group was too small. Hopefully the Phase III trial will be much larger and this drug will make it to market.

The safety of it along with the fact that it is so convenient makes it worth it for me. I have so many reactions to medications that I was very happy not to have any side effects while I was in the trial.

I am not looking a gift horse in the mouth on this one. But I certainly have to say that following the protocol to the letter was not easy, but I managed to do it. I traveled over 450 miles, one way, for each visit, at my own expense, just so I could hopefully find something that would stop all these darn relapses. I wait for that shoe to drop every 3 months for me and when it didn't happen, I was elated! Not having to do IVSM every 3 months is a celebration for me! My body is much happier and so it my pocketbook and my clients! I am self employed and not having to take 3=4 weeks off each time I have a relapse is certainly making my quality of life a whole lot easier!

So think what you want from the published/presented data at World Congress. I am a success story for this clinical trial - and I certainly hope that I start producing those MRTCs again so I can continue in the Extension Study.

Sign me happy...not anonymous!!!