This Is MS Multiple Sclerosis Community: Knowledge & Support

oo

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My neuro and I were just discussing this. Here is what I got from our discussion : a. Tovaxin has passed the preliminary safety analysis stage. b. If we have been receiving the Tovaxin, there is possibility that we could not be able to make a vaccine at the 52 week procurement. c. If this is the case, they will continue to check up on us every few months to see when a new vaccine will be needed.

So, it sounds like not being able to make a vaccine at this point is very different from not being able to make a vaccine in the beginning. I figured at some point our dosing schedule would be more individualized, but it never really dawned on me that this stuff would work so well/fast that we might not need another dose this soon.

Tim, what has been your experience with this? How do they determine your dosing schedule? How often are you receiving the vaccine? I look forward to reading your input on masking. It will be in all of our best interest to try to deliver the "best" blood we can.

Heather

Yes

Yes, but unlikely.

Yes, every 2 months, but read your protocol.

Yes and no. I think you are too focused on the rare few (I believe 2) that have stopped producing MRTCs.

Yes, after it is FDA approved.

It sounds like you may have gotten the real thing. Even if you have, the odds are that you will again be starting to produce MRTCs by the time you give your next bag of blood.

Every bag of blood had MRTCs and new vaccine was made.

Protocol; I do not have a special dosing schedule.

Five treatments at 8 week intervals -- 0, 8, 16, 24, 32, new bag of blood at 52, and repeat the process.

Yes

Bob, this was ten answers. The answer window is closed.

_________________
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

oo

Is this my new name, or the beginning of the ballad?

_________________
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

Tim,

I only "officially" asked 3 questions. The others were simply statements.

But seriously, Tim, thanks for getting back to me. Whether you like it or not, when it comes to Tovaxin, you're the man with the answers.

I like my doctor and all, but when it comes to getting the "lowdown", I like seeing what you guys have to say. Thanks for keeping us posted.

Heather

Hi Heather,

You are correct. You really only asked 3 questions. I made comments on your observations.

I have several postulates that I have made on this site.

The 4-day rule -- it is not an attack unless it lasts more than 4 days.

The 2 assessment rule -- if you EDSS changes and stays changed for 2 consecutive assessments, it is for real.

The 10 question rule AKA the Lyon rule -- every answer generates 10 more questions.

_________________
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

oo

Hi Bob,

I would email a link to the protocol and a link to the Tovaxin part of this site. That should be more than enough information and she will see if the sister is qualified. If you don't have her email address put the same things in a letter with the necessary URLs.

Even if she is not qualified for the next study, I assume Tovaxin will be approved in 2010, and available to the general population.

_________________
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

oo

"Even if she is not qualified for the next study, I assume Tovaxin will be approved in 2010, and available to the general population."

Every morning I go to this site and a few others hoping to read something encouraging. Today I smiled.

oo

Hi MaggieMae,

This post may be both encouraging and discouraging. I know you have loved ones who have MS. I believe that you have mentioned that it is SPMS. I don't know how many people in my study have SPMS, but the interim data reported at the international meeting in Greece at the end of 2005, showed that everyone in the study at that point had shown at least ½ of a point decrease in EDSS.

That data was not broken out into specific types of MS, but it is apparent that Tovaxin will work for SPMS. One individual in the study, who was diagnosed as SPMS, has had their EDSS drop from 6.0 to 2.0. I have not mentioned that before, because I do not want to tell other people’s stories or sensationalize Tovaxin. There are enough people on this site reporting great results that I feel it is okay to mention that person’s results.

Here comes my usual statement. The hope for Tovaxin is that it will stop the attacks. It is up to the patient’s body to restore damaged areas.

There was also a person with PPMS in my study. She was originally diagnosed as SPMS but it was later determined that she was PPMS. She had a ½ point decrease in her EDSS while in the study. When it was determined that she was PPMS, she was allowed to continue to receive Tovaxin, but her data is probably not part of the overall study data.

The company had originally planned to have the first study be for PPMS. So, they must feel it will work for PPMS as well as RRMS and SPMS. I assume that because the percentage of people with PPMS is very small, economics moved the study to RRMS and the current protocol.

So where is the bad news in this post? I assume that the protocol for the phase III study will be the same as the one for the IIb study. There may be some minor changes to the inclusion criteria, but I don't think they will be including other types of MS. The current study was designed to transition into the phase III, so for that to happen, the protocols must be the same.

On another site, I had answered Jane about how to get people into the next study that did not qualify for the current study. I pointed out that pleading, begging, or other emotional efforts are not sufficient reasons to modify the protocol. If you want to modify the protocol, read the protocols that were used for the CRAB drugs and Tysabri. If their inclusion criteria were broader than Tovaxin’s criteria, write that up, give it to your neurologist, and have him/her present the information to Opexa.

_________________
Best regards, Tim

In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.

Tim,

We have been dealing with MS since 1974. If it is on the market in 2010 and open to the general public, then my husband can't be denied. Right? My fear was that Tovaxin was going to get lost in the maze for another 10 years.

My husband deserves this chance. He has fought a hard battle to keep walking, which he can only do these last 10 years if he hangs onto something and not for any distance. He has shoveled dirt on his knees, laid stone, cut floor boarding, made the bed and anything else he could do from a kneeling position. His arms are strong and his mind is good. I don't want him to only walk in his dreams. I want to dance with him again. Enough of that - I'm getting too emotional.

On a side note: I must mention that because of all the articles I have read about Vitamin D, we had his levels checked. They were low. He has been taking Vitamin D3 and some other supplements. I really believe in the therory about Vitamin D and autoimmune diseases. Just had to mention.

oo