Tovaxin phase II failure

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edgwsyg
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Tovaxin phase II failure

Post by edgwsyg »

Hi all. My name is Ed. I have a sister with MS and I was e-mailing Chris about HiCy when I mentioned to him that I was following Tovaxin also.

If we all take a step back from the emotion surrounding Tovaxin -- believe me, I carry my sister in my heart every single day -- the only rational conclusion you can come to is that Tovaxin, at best, does not work ("no statistical difference from a placebo"), and, in all probability, was a scam to begin with. Yes, I bought $1,000 worth of Opexa stock about 2 years ago, but the real hope here was for Tovaxin to be a CURE. Here is my thread with Chris about Tovaxin:

In fact, in a past life I was a stockbroker. I lost all my money with Tovaxin, but I only put a $1,000 in to begin with. I've taken enough stocks to zero to understand that when a start up is in phase I, you do NOT bet the ranch on it. Tovaxin had all the great pictures and "testimonials" with it, but that means nothing. I've had people look me in the eye, say "I swear to God," and lie to me through their teeth.

Could Tovaxin still work? Maybe. But I'm not putting another penny in it.

I'll post on ThisisMS.


-----Original Message-----
Sent: Tuesday, September 30, 2008 9:43 AM
Subject: Re: HyCy and SPMS

I wish you would go to www.thisisms.com with what you just told me and put it into the Tovaxin forum there. They will not listen to me.

I think with your credentials, and the fact you and I are able to carry on an intelligent conversation would prove I am no dummy lol.

I tried for Tovaxin and by the grace of God I didn't make the MRTC's needed. I got really lucky with this.

I also got lucky to get my money out of Opexa. I also am lucky enough to be just beginning my TD ameritrade acct and it's a great time!

Chris

"A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort."

- Herm Albright

Our friendship is like sitting down to a breakfast of eggs and bacon. The chicken is dedicated to the cause but the pig is committed. I hope you are a pig.

On Tue, Sep 30, 2008 at 6:50 AM, wrote:

Thanks Chris. I know you're not making money off of this, but my God, you would not believe the people out there promising cures and miracles to people with MS, charging THOUSANDS, and then they disappear when the police start closing in. I had high hopes for Tovaxin, but if something gets cancelled in phase II, and the stock goes from $2.40 to 0.20, and the kid's father gets out after the phase II financing, I have to assume it was a scam until somebody proves otherwise.

All the best,
Ed.

-----Original Message-----
Sent: Monday, September 29, 2008 6:45 PM
Subject: Re: HyCy and SPMS

The biggest way to explain the RRMS SPMS and PPMS is this...in RRMS,SPMS there is still an immune system component to the disease and it shows up on the MRI as a lesion. In the later or worst case of MS aka PPMS there isn't much of an immune system factor. It's jumped it and went to the next stage which is much worse.

If there is no immune system factor in the MS restarting the immune system will not help.

I assure you I make 0 off of this. I hope God lets me have nice place someday as a reward for what I do. If I get worse I will not disappear.

Chris

On Mon, Sep 29, 2008 at 4:06 PM, wrote:

Thanks Chris. What do you make of this whole inflammation v. non-inflammation protocol? My sister is diagnosed as SPMS, which I suppose is non-inflammatory, but she gets weaker every year. I now think SPMS and PPMS is an excuse for neurologists and
pharmaceutical companies to throw away MS patients who've had it for more than a few years.

Thanks for fighting for the MS patient community out there. I think about the sham treatments I've seen, and the neurologists who believe that the meds they prescribe must be the only possible treatment option.
I see that Tovaxin has apparently failed a phase II trial, which tells me all of the buzz and the website and the "miraculous" recovery was a scam designed to defraud real patients and investors of their hopes and their money (why else would that kid's dad get out after the phase II financing?!?).

Best Regards,
Ed.

-----Original Message-----
On Behalf
Subject: Re: HyCy and SPMS

Baloney. Until you hear that from everyone you go to don't believe that crap. I know Rush in Chicago is treating SPMS patients one of which has been with this crud for 23 years.

I also know of someone who took a stack load of us to a bunch of oncologists and neuro's until they agreed to do it. I can't
open my mouth about that yet and who it is.

Unfortunately with HiCy it does seem that some lesions being present helps. If the MS is not the inflammatory type aka the
progressive type, this may not work. Let the folks doing the treatments make that decision.

Good luck to you. I hope you can qualify.
Chris

Hi Chris,

My name is Ed and I'm writing on account of the
article about cyclophosphamide this summer in the Johns Hopkins journal.
I just saw the article recently. I came upon your website through the THIS is MS website. I'm writing about my sister Janet. Janet is 40 and has been wheelchair-bound due to MS for 10 years now. I just spoke to [a MS doctor's] office in Bay Shore, L.I. (NY). Terry from his
office just told me that his office is only treating patients who can walk,
even with a walker, and HiCy is only available to patients who
participate in research trials. Is this the case at Johns Hopkins also?

Not to sound cynical as a family member who has watched
his baby sister take Avonex for 16 years now, and seen her neurologist
decline to prescribe her Tysabri and even LDN, but this seems like more of
the same old medical monopoly.

Congratulations on your recovery. I'm glad that people with MS who can still walk have reason to hope for a cure, but I guess people
who've had MS for more than 10 years who can't walk anymore in
America should start making funeral arrangements. And doctors wonder
why people are going to Mexico, South America and China for medical
treatment.

I'd be interested in any information you can provide.
Thank you, and continued Godspeed in your recovery.

Best Regards,
Ed.
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av8rgirl
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Re: Tovaxin phase II failure

Post by av8rgirl »

Excuse me Ed..but I think you are wrong and I am going to just say it. I don't remember ever reading anything that said Tovaxin was a cure. Tovaxin is another treatment for MS. Chris is probably the only person ( and I am assuming you are talking about Chrishasms Chris) who thinks that all treatments should be a cure.

I have been in the Tovaxin trial and have just found out today that I was receiving the drug not placebo. For every failure there is a success story. I am a success. I went from 4 exacerbations a year on the approved therapies to ONE exacerbation a year on Tovaxin.

You can call this a scam, a failure or whatever you want, but I am quite happy with the treatment thus far.

Look at the "scare tactics" that the press used when the Tysabri clinical trials were going on! Oh my god...you'd think that the entire population of MS patients on Tysabri were going to die. I had 2 infusions of it before it was pulled from the market and guess what? I didn't die. Look at how that has turned around. I bought stock. I lost money. And so did a lot of other people.

But you know what? I am not crying in my beer about it. So, Ed...get a life. I have MS and it's not going away in my lifetime. There is NO cure for MS right now.

Take what Chris says with a grain of salt...or maybe a lot of salt with a margarita and chill.

It's a clinical trial. We all have a lot to learn YET about this medication. It ain't over yet. Sit back, relax, let's see what the next phase brings. I am sorry it hasn't worked for your pocketbook nor your sister. Not all drugs work for everyone.
edgwsyg wrote:Hi all. My name is Ed. I have a sister with MS and I was e-mailing Chris about HiCy when I mentioned to him that I was following Tovaxin also.

If we all take a step back from the emotion surrounding Tovaxin -- believe me, I carry my sister in my heart every single day -- the only rational conclusion you can come to is that Tovaxin, at best, does not work ("no statistical difference from a placebo"), and, in all probability, was a scam to begin with. Yes, I bought $1,000 worth of Opexa stock about 2 years ago, but the real hope here was for Tovaxin to be a CURE. Here is my thread with Chris about Tovaxin:

In fact, in a past life I was a stockbroker. I lost all my money with Tovaxin, but I only put a $1,000 in to begin with. I've taken enough stocks to zero to understand that when a start up is in phase I, you do NOT bet the ranch on it. Tovaxin had all the great pictures and "testimonials" with it, but that means nothing. I've had people look me in the eye, say "I swear to God," and lie to me through their teeth.

Could Tovaxin still work? Maybe. But I'm not putting another penny in it.

I'll post on ThisisMS.


-----Original Message-----
Sent: Tuesday, September 30, 2008 9:43 AM
Subject: Re: HyCy and SPMS

I wish you would go to www.thisisms.com with what you just told me and put it into the Tovaxin forum there. They will not listen to me.

I think with your credentials, and the fact you and I are able to carry on an intelligent conversation would prove I am no dummy lol.

I tried for Tovaxin and by the grace of God I didn't make the MRTC's needed. I got really lucky with this.

I also got lucky to get my money out of Opexa. I also am lucky enough to be just beginning my TD ameritrade acct and it's a great time!

Chris

"A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort."

- Herm Albright

Our friendship is like sitting down to a breakfast of eggs and bacon. The chicken is dedicated to the cause but the pig is committed. I hope you are a pig.

On Tue, Sep 30, 2008 at 6:50 AM, wrote:

Thanks Chris. I know you're not making money off of this, but my God, you would not believe the people out there promising cures and miracles to people with MS, charging THOUSANDS, and then they disappear when the police start closing in. I had high hopes for Tovaxin, but if something gets cancelled in phase II, and the stock goes from $2.40 to 0.20, and the kid's father gets out after the phase II financing, I have to assume it was a scam until somebody proves otherwise.

All the best,
Ed.

-----Original Message-----
Sent: Monday, September 29, 2008 6:45 PM
Subject: Re: HyCy and SPMS

The biggest way to explain the RRMS SPMS and PPMS is this...in RRMS,SPMS there is still an immune system component to the disease and it shows up on the MRI as a lesion. In the later or worst case of MS aka PPMS there isn't much of an immune system factor. It's jumped it and went to the next stage which is much worse.

If there is no immune system factor in the MS restarting the immune system will not help.

I assure you I make 0 off of this. I hope God lets me have nice place someday as a reward for what I do. If I get worse I will not disappear.

Chris

On Mon, Sep 29, 2008 at 4:06 PM, wrote:

Thanks Chris. What do you make of this whole inflammation v. non-inflammation protocol? My sister is diagnosed as SPMS, which I suppose is non-inflammatory, but she gets weaker every year. I now think SPMS and PPMS is an excuse for neurologists and
pharmaceutical companies to throw away MS patients who've had it for more than a few years.

Thanks for fighting for the MS patient community out there. I think about the sham treatments I've seen, and the neurologists who believe that the meds they prescribe must be the only possible treatment option.
I see that Tovaxin has apparently failed a phase II trial, which tells me all of the buzz and the website and the "miraculous" recovery was a scam designed to defraud real patients and investors of their hopes and their money (why else would that kid's dad get out after the phase II financing?!?).

Best Regards,
Ed.

-----Original Message-----
On Behalf
Subject: Re: HyCy and SPMS

Baloney. Until you hear that from everyone you go to don't believe that crap. I know Rush in Chicago is treating SPMS patients one of which has been with this crud for 23 years.

I also know of someone who took a stack load of us to a bunch of oncologists and neuro's until they agreed to do it. I can't
open my mouth about that yet and who it is.

Unfortunately with HiCy it does seem that some lesions being present helps. If the MS is not the inflammatory type aka the
progressive type, this may not work. Let the folks doing the treatments make that decision.

Good luck to you. I hope you can qualify.
Chris

Hi Chris,

My name is Ed and I'm writing on account of the
article about cyclophosphamide this summer in the Johns Hopkins journal.
I just saw the article recently. I came upon your website through the THIS is MS website. I'm writing about my sister Janet. Janet is 40 and has been wheelchair-bound due to MS for 10 years now. I just spoke to [a MS doctor's] office in Bay Shore, L.I. (NY). Terry from his
office just told me that his office is only treating patients who can walk,
even with a walker, and HiCy is only available to patients who
participate in research trials. Is this the case at Johns Hopkins also?

Not to sound cynical as a family member who has watched
his baby sister take Avonex for 16 years now, and seen her neurologist
decline to prescribe her Tysabri and even LDN, but this seems like more of
the same old medical monopoly.

Congratulations on your recovery. I'm glad that people with MS who can still walk have reason to hope for a cure, but I guess people
who've had MS for more than 10 years who can't walk anymore in
America should start making funeral arrangements. And doctors wonder
why people are going to Mexico, South America and China for medical
treatment.

I'd be interested in any information you can provide.
Thank you, and continued Godspeed in your recovery.

Best Regards,
Ed.
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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edgwsyg
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Tovaxin phase II failure

Post by edgwsyg »

Wow, "Get a life?" You don't think you're taking this a bit personally when all I did was report that Tovaxin just failed a phase II trial, which it did, and the stock went from $2.40 to $0.20 (basically zero)?

Nobody's crying about money. When you buy a stock you take the risk that it'll go to zero. I understand that. I've been in the market for over 20 years.

Here's what I said: I was hoping for a cure - for my sister. But here's a bit of news - when a new drug fails phase II, it doesn't go to phase III. That's not how it works. Drugs that fail phase II disappear.

There's no need to flame people for reporting what is published by Reuters and the AP, and moreover, what is now recorded with the FDA.
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Re: Tovaxin phase II failure

Post by JanethePain »

edgwsyg wrote: ... There's no need to flame people for reporting what is published by Reuters and the AP, and moreover, what is now recorded with the FDA.
Wow, three of you on the boards at one time to give us the "truth" about Tovaxin. To what do we owe this little Trinity of Gloom and Doom--an account that allows unlimited screen names?

For whatever reason(s), you and/or your family members won't be taking Tovaxin.

Okay. Don't take it. No one's begging you.

Many of us here have made other decisions. You don't like them, feel free to take a cyber hike.
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Re: Tovaxin phase II failure

Post by hmtucker »

edgwsyg wrote:You don't think you're taking this a bit personally when all I did was report that Tovaxin just failed a phase II trial, which it did, and the stock went from $2.40 to $0.20 (basically zero)?
Why should we take it personally when you describe the minimal information to be released from a preliminary analysis of the TERMS data to be a complete failure and that we've all been scammed for being a part of it? As a scientist and participant your world of absolutes as a stockbroker makes me more than chuckle! Given how the stock price dropped I'm betting that the rest of the brokers are as knowledgeable about medical research as you are.
edgwsyg wrote:There's no need to flame people for reporting what is published by Reuters and the AP, and moreover, what is now recorded with the FDA.
As for flaming people, I'm amazed at the number of people who have crawled out of the shadows who seem pretty pissed off and have told all of us who are participants in this study that we are fools, that we've been scammed, that we should perform beastiality on our horses and other flattering terms all because we seem to take a different read on the data that has been released than they do. Is it too hard for you folks to believe that some of us are comfortable with how things are going in the study for us and that we are choosing to continue with the extension. It will be nice when the rage of some people subsides and we can return to the exchange of useful information.

Mike
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edgwsyg
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Tovaxin

Post by edgwsyg »

Everybody is welcome to do whatever they like. I think anybody reading these posts can draw their own conclusions as to who's angry and who's not. For those of us who care about facts, here's the Reuters write-up about Tovaxin:


UPDATE 1-Opexa drug trial fails; shares plummet
Fri Sep 19, 2008 5:05pm EDT Email | Print | Share| Reprints | Single Page | Recommend (1) [-] Text [+]

Sept 19 (Reuters) - Opexa Therapeutics Inc (OPXA.O: Quote, Profile, Research, Stock Buzz) said a mid-stage trial of its treatment for multiple sclerosis failed to meet its main and secondary goals, wiping out more than 94 percent of its market value.

The drug developer said the results of tovaxin, its multiple sclerosis vaccine, was not statistically significant against a dummy drug but it had a favorable safety profile.

Opexa plans to complete a comprehensive analysis of data and meet the U.S. Food and Drug Administration during the first half of 2009 to discuss further development of tovaxin.

Shares of the company lost $2.12 and closed at $0.22 Friday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Gopakumar Warrier)
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Re: Tovaxin

Post by av8rgirl »

edgwsyg wrote:Everybody is welcome to do whatever they like. I think anybody reading these posts can draw their own conclusions as to who's angry and who's not. For those of us who care about facts, here's the Reuters write-up about Tovaxin:


UPDATE 1-Opexa drug trial fails; shares plummet
Fri Sep 19, 2008 5:05pm EDT Email | Print | Share| Reprints | Single Page | Recommend (1) [-] Text [+]

Sept 19 (Reuters) - Opexa Therapeutics Inc (OPXA.O: Quote, Profile, Research, Stock Buzz) said a mid-stage trial of its treatment for multiple sclerosis failed to meet its main and secondary goals, wiping out more than 94 percent of its market value.

The drug developer said the results of tovaxin, its multiple sclerosis vaccine, was not statistically significant against a dummy drug but it had a favorable safety profile.

Opexa plans to complete a comprehensive analysis of data and meet the U.S. Food and Drug Administration during the first half of 2009 to discuss further development of tovaxin.

Shares of the company lost $2.12 and closed at $0.22 Friday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Gopakumar Warrier)
That was a reporter's point of view. Have you listened to the webcasts and the conference calls? Have you read the PATIENTS posts who have been in this trial?

Gee, I don't consider this a failure. And if I remember correctly, the Phase III protocol has been approved. The Extension study is in full swing, and I haven't heard about anything being cancelled.

So, Mr. ED...opinions are like...well you know ... everyone has one and you are entitled to yours.

The clinical trial doc that ran my site doesn't consider this a failure. I flat out asked him.

In fact, this is the first medication that has actually stopped me from having so damn many exacerbations a year. That to me is not a failure. That is an improvement. I have been on Betaseron, Betaseron plus Methotrexate, IVSM pulse, Tysbari, Copaxone, and just IVSM pulse. Do you think I would be a lab rat for nothing???? My next option is chemo. I am not ready for that as this has definitely slowed my exacerbation rate by 75%...so duh. I am not a fool.

You sound like one of those bitter investors plain and simple. Quoting one of our esteemed members...take a cyber hike Mr. Ed!!!
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
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Post by Lyon »

..
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Post by Ant148 »

simply put -- tovaxin sucks, ok? fucked me over hard, didn't work for others documented on this very site, and more importantly didn't make a diddly squat of a statististical difference against the placebo. now, to those that did great on it, more power to you. i'm glad it helped you but quit defending a crappy drug when it DIDN'T help the majority of subjects. what's your logic there? it helped me so it's a great drug? doesn't work that way, kiddies. if opexa wants to keep it going and you want to participate in the extension, that's great too. maybe it'll pan out in the future after all. however, you can't blame us for seeing the writing on the wall -- drug sucks, stock in the toilet, end of tovaxin story. oh well, shit happens...

ps Mike don't put me in your group of "flaming people who have crawled out of the shadows who seem pretty pissed off and have told all of us who are participants in this study that we are fools, that we've been scammed, that we should perform beastiality on our horses". i was in the trial to the hilt, ok? i got the actual tovaxin and it didn't help but actually hurt me. i'm not claiming anyone in the trial is a fool or has been scammed. the horse thing was in response to an asshole that attacked me unprovoked. any more explanation needed?
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Re: Tovaxin misinformation

Post by NHE »

Ant148 wrote:simply put -- tovaxin sucks, ok? fucked me over hard, didn't work for others documented on this very site, and more importantly didn't make a diddly squat of a statististical difference against the placebo. now, to those that did great on it, more power to you. i'm glad it helped you but quit defending a crappy drug when it DIDN'T help the majority of subjects. what's your logic there? it helped me so it's a great drug? doesn't work that way, kiddies. if opexa wants to keep it going and you want to participate in the extension, that's great too. maybe it'll pan out in the future after all. however, you can't blame us for seeing the writing on the wall -- drug sucks, stock in the toilet, end of tovaxin story. oh well, shit happens...
Misinformation happens as well. While it is true that Tovaxin failed to be significantly different from placebo in the study's primary endpoint, i.e., gadolinium enhancing lesions, it did reduce relapse rate in the treatment group when compared to placebo. This point was made particularly clear in Opexa's conference call dated Sept. 22, 2008.

There was...
  • a 37% decrease in the annualized relapse rate across the total study population receiving Tovaxin
  • a 42% decrease in the annualized relapse rate in the gadolinium positive population
  • a 55% decrease in the annualized relapse rate in patients who went into the study with a relapse rate greater than 1 in the year prior to study entry
Opexa indicated that they were in discussion with the FDA and that reduction in annualized relapse rate would be the primary endpoint for any phase III trial.

Moreover, the annualized relapse rate was 0.21 for the treatment group which is equal to or better than any of the CRAB drugs.
i was in the trial to the hilt, ok? i got the actual tovaxin and it didn't help but actually hurt me. i'm not claiming anyone in the trial is a fool or has been scammed.
There are other possible explanations to consider. You have admitted that you were not compliant with the study's protocol on several points. It could be possible that one of the unapproved substances you were using was actually harmful or interacted negatively with Tovaxin. It could also be the case that your MS was simply unresponsive to Tovaxin as each person's disease is slightly different and not all people respond to each drug in the same way. An additional factor is that the worsening of your disease that you experienced would have occurred anyways and that for you it just happened to be coincidental with the time period of your enrollment in the Tovaxin trial.

My perspective is that the study may have been poorly designed. Opexa has stated that there was an unequal distribution of patients between the treatment and placebo groups. In effect, the patient population in the Tovaxin arm had a greater number and volume of gadolinium positive lesions than the patient population in the placebo arm of the trial. The difference being greater than a factor of 2. Now there are non-parametric statistical methods which can be used for comparing two populations with unequal variance (parametric analysis assumes equal variance between populations). As the number of subjects in a study increases, the differences in population variance tend to equal out thus running a larger study will usually produce better data than a small study. A hundred people on Tovaxin is still kind of small especially when compared to the typical phase III study. It is my guess that Opexa will likely consider non-parametric analysis as they continue to probe their data set. Since the unequal variance in their study populations appears to have come as a surprise to them, this type of analysis was likely not built into their initial experimental design which may have prevented them from using it for their "top line" analysis. I expect that once they have taken the unequal population variance into account that their results will be much more favorable.

Lastly, with respect to the sharp decline in Opexa's share price, in the current volatile stock market that we now have, it's likely that the stock market over reacted to the news from the top line analysis. In more normal times, the decline may have been attenuated somewhat.

NHE
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Post by JanethePain »

Ant148 wrote:... ps Mike don't put me in your group of "flaming people who have crawled out of the shadows who seem pretty pissed off and have told all of us who are participants in this study that we are fools, that we've been scammed, that we should perform beastiality on our horses". i was in the trial to the hilt, ok? i got the actual tovaxin and it didn't help but actually hurt me. i'm not claiming anyone in the trial is a fool or has been scammed. the horse thing was in response to an asshole that attacked me unprovoked. any more explanation needed?
What a pity Hint-Taking 101 isn't offered as remedial instruction where you live. So let's review (quiz on Monday):

1) Tovaxin hasn't worked for you.
2) Tovaxin HAS worked for others, by whatever means they and their doctors define "success."
3) A little bit of whining disappointment is par for the course in something as serious as MS
4) You've exceeded your quota of it
5) Thank whatever deity (-ies) you worship that you aren't in bitch-slapping range
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Post by Aggie03 »

Wow, all this bickering back and forth is just sad.

So Tovaxin didn't work for everyone and it didn't have the results that everyone was hoping for, that is why they do clinical trials. I hate the individuals that were not even involved in the clinical study have come here and bashed Opexa and people that were in the study, I just don't think that is right.

For the people that Tovaxin didn't help, I'm sorry but you tried something new and it may have helped progress research that is trying to find something that will help those of us that have this damn disease.

I will continue in the trial as long as I can and am doing ok. I was getting the real think and have been doing very well. Is that because the drug works on me? or is it because my MS just has not progressed as others have? I don't know, the Dr's don't know and I don't know if we ever will. One thing that I can say, I will always be positive about staying healthy and if that means Tovaxin or some other drug, then so be it.

I hope that people can move on and try to get the help they need to be healthy in this trial or somewhere else.
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Post by Lyon »

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Post by av8rgirl »

I feel very fortunate that I am one that has been helped by Tovaxin. It is the first drug that has helped me since I was dx'd. I hope to continue in the Extension study ... I just need to produce those MRTCs so I can get that vaccine made!

Now we all know why I have been MRTC negative for so long. This has really worked for me! I am happy!
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