This Is MS Multiple Sclerosis Community: Knowledge & Support

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I was not planning on posting again on the Tovaxin forum but here is what I think.

I am giving a warning to everyone who only wants to see positive in Tovaxin to stop reading now and ignore my post.








These are the results of the phase IIb trial.

http://www.thisisms.com/ftopict-6145.html

It says:

- “the study did not achieve statistical significance with its primary endpoint, the cumulative number of gadolinium-enhanced brain lesions.”

- The article also says that the study did not reach statistical significance when it comes to the annualized relapse rate.


The data that Opexa published later does not make fair comparisons:
http://www.thisisms.com/ftopict-6295.html


In a trial, you are have 2 groups that are equivalent. One group was to receive Tovaxin (the experimental group) and another would receive a placebo (the control group). The information that Opexa published later does not make a fair comparison. The 2 groups that they are comparing are not equivalent. Opexa simply looked at all the data and tried to find a way to present the information to make their product look good.


I know that someone is going to bring up the fact that the original randomization was not fair because Opexa said that the group receiving Tovaxin had a more active disease than the placebo group. Opexa is the one who randomized participants to either placebo or Tovaxin.


As for what they published later, you cannot just single out a group of people (“The latest analysis focused on a prospective group of patients (n=50) with an annualized relapse rate (ARR) of greater than 1 at study entry which is comparable to ARR baselines of patients in previous Tovaxin studies)” if the placebo group you are comparing to is not similar.


Who knows, maybe certain people would really benefit from this therapy or perhaps it could be improved and become a more effective treatment option. But, my point is that in what has been published so far, all I see is that the people working at Opexa are very good at playing with the data. The trial did not achieve statistical significance in it's primary or secondary endpoint

Bob,
I think you're feeling remorse over not letting me draft you for president, sounds like you're having second thoughts now.......
Ken

Just for the record, I really, really, really wish Tovaxin had worked out and my feeling has nothing to do with the stock.

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My Starting Point
Understanding MS 101: Doctor Talk and People Talk<br /><br />

Ditto on that Ken.

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http://myhopefuljourneyintoactualmsreco ... ogspot.com

Just read this article on another site. Makes me feel discouraged, sad, angry, etc., etc.


Thursday, November 13, 2008
Here Is something that MIGHT ( or Might NOT ) Shock You
Rigged Clinical Trials: Drug Studies Favor the Pharmaceutical Companies
Companies more concerned with profits than with patients



Global Research, November 7, 2008
Orthomolecular Medicine News Service - 2008-11-05


If you have often suspected that drug studies are rigged by the pharmaceutical manufacturer, you are right. "Drug studies skewed toward study sponsors," reported The Washington Post. (1) "Industry-funded research often favors patent-holders, study finds." Specifically, the American Journal of Psychiatry study authors said, "In 90% of the studies, the reported overall outcome was in favor of the sponsor's drug... On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug." (2)

Marcia Angell, MD, former editor-in-chief of the New England Journal of Medicine, agrees. "Is there some way (drug) companies can rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in a dozen ways, and it happens all the time." One "way to load the dice," she writes, "is to enroll only young subjects in trials, even if the drugs being tested are meant to be used mainly in older people. Because young people generally experience fewer side effects, drugs will look safer." Another of the "common ways to bias trials is to present only part of the data - the part that makes the product look good - and ignore the rest." She adds, "The most dramatic form of bias is out-and-out suppression of negative results." (3)

You will rarely hear academia complain. Why? Because they are aboard the gravy train. Dr. Angell: "Columbia University, which patented the technology used in the manufacture of Epogen and Cerezyme, collected nearly $300 million in royalties" in 17 years. "The patent was based on NIH-funded research." That means you, the taxpayer, footed the bill. Harvard is in just as deep. In its own Faustian dealings with the drug companies, "a Harvard hospital has a deal that gives Novartis rights to discoveries that lead to new cancer drugs ... Merck is building a twelve-story research facility next door to Harvard Medical School . . . In Harvard Medical School 's Dean's Report for 2003-4, the list of benefactors included about a dozen of the largest drug companies."

READ THE COMPLETE Story - found at the the Center for Research Globalization

Hate to nitpick here, guys, but IIb won't be finished until the last one of us completes that second round of Week 52.

Now that preliminary report has been a little disappointing overall, but in my case, "the only thing better than [my results] is a cure." And that's straight from my neuro's mouth, too.

It's my understanding that Av8rGrl's relapse/attack rate has declined significantly, too.

Even if Tovaxin proves to work only as well as the interferons, it would still be a huge benefit because of the safety issues. And general tolerability issues. That fatigue profile with Avonex was just about my undoing. UGH.

I meander back for my second shots this coming Tuesday. I'll see what I can dig up in the gossip pipeline.

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Jane the Pain

MaggieMae, the article you posted was extremely interesting.




I have to say that I feel the same way you do!






The phase IIb trial is a study that lasted one year (http://www.clinicaltrial.gov/ct2/show/N ... xin&rank=1 ). The last person enrolled in the trial completed her/his one year in the study last August. The phase IIb trial was called the TERMS trial (Tovaxin for early relapsing Multiple Sclerosis). The phase IIb was completed and the results were the ones announced last September.

There is now an extension study for those who want to participate and who completed the TERMS trial. The extension study is called “Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis (OLTERMS). “ http://www.clinicaltrial.gov/ct2/show/N ... xin&rank=2






Again the one year phase IIb trial was completed and these are the results:
http://www.thisisms.com/ftopict-6145.html

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Here's the slide show from Opexa's Nov 11th presentation in an easy to read/print pdf format.

NHE

On Page 5, they say .28 ARR for Tovaxin. On page 6 they say "Tovaxin ARR lowest of any marketed or developed therapy" and again state the ARR at ".28 relapses/patient/year". Yet on page 5, Tysabri is shown as being .22; wouldn't that be lower?

Now, on page 18, the graph shows ARR for Tovaxin at .214. It does not tie into their previously stated .22 value, but then does make sense with their claim of "lowest" ARR.

And then on page 30 they say "Lowest ARR of most marketed drugs".

Am I reading it all wrong?

The presentation does seem a little confusing in places. For example, I think that the 0.28 ARR that's quoted on page 5 is really associated with the subset of patients discussed later in the presentation with an ARR >1 (see page 20). However, they don't appear to make the distinction between the different groups on page 5.

In addition to the points that you mentioned, I noticed an issue with the information presented on page 19 and 20 which seem to be in conflict with each other. For example, on page 19 Opexa states that the ARR was 0.282 for patients in the Tovaxin treatment group with an ARR > 1 in the year prior to study entry and that this was a 55% reduction compared to patients in the placebo group that also had an ARR > 1. In contrast, page 20 states that in this group of patients, the 55% reduction in ARR, i.e., 0.28 vs. 0.63, was patients at the end of the study at 52 weeks.

While I believe that Tovaxin may indeed be helpful for some patients, I'm left to conclude that this presentation was a little haphazardly put together. Perhaps several people were involved in producing the data for the slides and it was not edited well. Either that or I'm really missing something concerning the data.

Moreover, I'm also left wondering why they chose to go with only 5 vaccinations for the entire year. I realize that it would increase the cost of the trial, but if they were trying to maximize Tovaxin's treatment effect, then a greater number of vaccinations might be the way to do it.

NHE