This Is MS Multiple Sclerosis Community: Knowledge & Support

I saw a question wondering about if people from the placebo arm were kicked out or not...or something to that effect.


I believe it was Chris S...aka PVNS who was kicked out of the trial because he still had TOO MANY new lesions. That always seemed very, very shady to me. Check with him for the exacts but I would bet $100 on it.

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My 2c (which is worth even less in new zealand)...I had been crossing fingers waiting for these results to be announced but deep down I have to say I wasn't too surprised. How many drugs show incredible Phase I results (cancer killers seem to be announced every year that fail at Phase II and III) and don't translate through to the population at large.

I look on Tims input here as similar to the Comcast guy on twitter - its fantastic to hear from someone on the inside, and I've really appreciated reading his posts. As long as you realise your talking to a company man I don't have any problem with his perspective.

On a more positive note the recent news on Tysabri has convinced me thats the route my wife to take http://www.rttnews.com/Content/QuickFac ... ck%20Facts

I feel so bad even weighing in on this and if I hadn't broke legs trying to get into this I would have no right.

I hate to be the downer but where is Tim? Has he said anything? I have seen nothing but bad vibes towards him but no one said he made them do this. He received this bad news as well. He may have just found out the one thing working for him can't be made anymore and now he's just going to go back to how he was.

Opexa may be toast folks...there stock went from over 2 dollars to less than 25 cents.

Bob can they still operate? If so I would like to know how.

Excuse my french but this really fucking sucks for all of you.

Just to try and keep things straight, that's NOT what they indicated in the data that was presented. They did not describe lesion volumes AFTER treatment with Tovaxin. From what they released: "It is important to note that initial review of data revealed that patients in the study’s Tovaxin arm, on average had a substantially greater number of MRI brain lesions and corresponding lesion volumes AT BASELINE compared to the average number of MRI brain lesions and lesion volumes per patient in the placebo group. The company believes that this unexpected imbalance may have contributed to the study not achieving its primary and secondary endpoints as patients in the Tovaxin arm began the study with greater disease burden and increased severity of disease."

We will have to wait for the complete data release to find out what happened with lesion volumes, probably as a percent of baseline type comparison, for the Tovaxin and placebo arms before we can address this issue fully.

Mike

That my friend is great great advice.

Mike,
Opexa went to great lengths to highlight the fact that there was "over 90 % reduction" in the first phases. I can assure you that is how they achieved funding and willing recruits. I can also assure you that if there were any way to make that case now.....they would have. This has nothing to do with the number of lesions a patient started with (ie a higher # in the vaccine arm) only the difference between start and finish. Reduction is reduction, increase is increase. Maybe I'm making this too simple or maybe we have gone to a new Math system here in the US but to coin a overly used phrase involving pigs and lipstick...........
Lars

I listened to the Conference Call

Sounds like the problem is that team Placebo did unbelieveably well. I don't fully understand the bits of data that are being presented, however, I'd hope that an expert here like ........ Lyon might be able to make sense of it. The conference call is only up and available for a few days. Ken

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Lars,

Yes, Opexa highlighted the 90% reduction data from their previous studies. In the data that has been released so far for the IIb study they ONLY mention lesion volume AT BASELINE. You can assume, suppose, hypothesize a lot of things but to go from a statement concerning lesion volume at baseline to your assumption that lesion volumes increased for the Tovaxin arm is simply not valid with the information that we have in hand at this point. Also, whether the lesion volume increased or decreased has EVERYTHING to do with the number of lesions and lesion volume that the patient started with... that's how you come up with a percent change from start to finish. Although we all would love to have the information, at this point we have no data regarding changes in lesion volumes. Once those data are released THEN we can discuss the "reduction is reduction, increase is increase" topic.

My whole point here is that let's deal with the data that has actually been released and not go into a feeding frenzy on what we think is written between the lines. Yes there is a lot of information that they did not present. Given that the last people have only very recently finished up the IIb phase, my bet is that a lot of the data has not even been analyzed at this point. So, that certain data was not discussed does not necessarily indicate that it did not turn out in Opexa's favor. I'll point it out again that in a 15 minute presentation at a scientific meeting the general setup is to spend 3 to 5 minutes introducing your project and providing background information, closer 5 minutes for a new and complex treatment paradigm, 5 to 7 minutes presenting the current data and then 5 minutes for questions. So, it is just impossible to present all of the data in a fully explained version in this setting even if you have all of the data fully analyzed.

Mike

Hi everyone,

though I'm as disillusioned as anyone else here I do think that the overall low ARR in placebo and verum sheds a bad light on the treatment - but still about 50% in favour of Tovaxin, while the CRABs are around a 30% improvement.

In addition it would be interesting to see what the average change in EDSS has been - though 52 weeks might be too short to see a significant treatment effect in this parameter.

Overall Tovaxin is one of the very rare treatments with a selectively immunmodulating mechanism of action - it would be a sin to drop it so early due to financial reasons.

If you look at the many costly trials that even today are still underway to determine - just one more time - wheter one INF is slightly superior to the others or compare GLAT to INF, one can get really frustrated about how money is distributed and used.

--Frank

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Treatment: CCSVI both IJV ballooned 09/2010, No DMDs, Tysabri on hold after 24 Infusions, after LDN, ABX Wheldon Regime for 1 year.

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I was just looking at results from the study of the "Fingolimod" Phase II study. They actually had 255 patients enrolled. During the study the placebo group had an ARR of 0.77 and the "Fingolimod" group had an ARR of 0.35. From that point of view, it does not seem so unlikely, that the placebo group in the Tovaxin study did really unusually well. So, if we compare the Fingolimod-placebo 0.77 to the Tovaxins 0.21, we see reduction of almost 75%. Which still is not 90%, but much better than any other therapy. Especially if we take into account, that there are almost no side effects.

Just my thoughts.

Hansjoerg

Bob,
How about a stupid and fully unscientific thought. Phase 1 and 11 results are obviously quite different from 11b, so what's the commonality. I see two, patients and the drug itself. Tovaxin has been "tweaked" and "re-tweaked" endlessly to improve it's effectiveness, maybe the opposite was achieved.
Lars

Well I just got back from my site after receivning Solu-Medrol. The doctor stopped in and talked to me about these results. He was at ECTRIMS. I said that I was hearing that they were bad on the internet and I wanted his opinion. He said 'you're hearing right'. 'Nuff said for this guinea pig.

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