TOVAXIN ROLE CALL

A board to discuss Tcelna as a treatment for Multiple Sclerosis

Postby Lyon » Sun Jun 03, 2007 7:39 pm

Hi Tim,
IHaveMS-com wrote: The blood cells frolic and have a merry old time.
:lol: Well that eases my mind that the little buggers have an enjoyable trip to the lab!

IHaveMS-com wrote:Maybe masking is like dangling a worm in front of a fish. If the fish isn't hungry or is not stimulated by the bait, it does not go after the bait. Opexa dangles 100 different peptide fragments over 3 of the major myelin proteins to identify an individual's MRTC set. Why don't the MRTCs go for the bait? If this is in fact the case, then masking would down-regulate the appetite of MRTCs and there by lessen attacks. I really do not have a handle on this.
Pretty much you're just restating the problem as I already suspected it to be. You know more about it than I do but I'm pretty sure I personally don't know enough about it to even guess. I will say that when I was reading through your last posting it did flash through my mind that this might have something to do with whatever is behind the relapsing/remitting aspect.

There obviously is nothing new regarding the mechanisms responsible for masking other than it being an unknown situation until Opexa started trying to identify mrtc's revealed it.
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Postby Lars » Mon Jun 04, 2007 8:06 am

Tim & Bob,
Could it be as simple as as this disease is complex? That varying stages of progression, remission or neutrality dictate the MRTC level. With that theory in mind, it would be impossible to judge every positive or negative test without interviewing every patient as to their condition at the time of blood retrieval. Personally I had no doubt I would test positive given my state at that time. Maybe it's time for a survey.
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Postby Lyon » Mon Jun 04, 2007 1:01 pm

Lars wrote:Could it be as simple as as this disease is complex? That varying stages of progression, remission or neutrality dictate the MRTC level.
Hi Lars,
As far as I can tell that seems to be a logical conclusion. Since that seems so obvious I guess I'd have to know more about what originally led researchers NOT to come to that conclusion and instead come to the conclusion that mrtc's are being masked in some cases. Hopefully Tim will know something about that aspect.

Bob
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Postby IHaveMS-com » Mon Jun 04, 2007 2:20 pm

Quote from Bob

I will say that when I was reading through your last posting it did flash through my mind that this might have something to do with whatever is behind the relapsing/remitting aspect.


The name relapsing remitting describes the nature of the disease. I usually refer to the action of RRMS, as waxing and waning, like the phases of the moon. You can think of the full noon as an attack and a moonless night as a remission.

SPMS no longer have moonless nights. I assume the MRTCs still wax and wane, but they never sufficiently decrease in number to the point where the body’s repair mechanism can provide enough restoration for the patient to regain some of what had been lost during an attack.

The body’s does not seem to have any defense against autoimmune diseases. With self-reactive cells, the body produces them and is not able to realize that they are destructive. In the case of MS, the oligodendrocytes, which repair myelin damage, are what bring back some lost function. Their action is an important part of the remission in RRMS. If you can bring the number of MRTCs down to near zero, the body will try to repair itself.

The CRAB drugs are an immunosuppressant. Tysabri is a monoclonal antibody that blocks most if not all WBCs from passing through the BBB, essentially leaving the brain defenseless and open to opportunistic diseases like PML. If I had an aggressive form of MS and was not able to control the advance of disease disability, I would consider Tysabri as a viable option. Anyone contemplating that would have to weigh the risks verses the benefits, and also decide how long to stay on it.

Quote from Lars

That varying stages of progression, remission or neutrality dictate the MRTC level.


Every time the body is triggered, the memory WBCs respond by producing MRTCs. Corresponding to the increased number of times that a patient’s memory WBCs are stimulated to produce MRTCs, the body will respond by making more memory WBCs to defend against this repeated threat. It is with repeated expose to chickenpox that the body maintains a sufficient number of chickenpox memory WBCs to prevent another case of the pox. Without repeated exposure to stimulate the memory WBCs, they will slowly dwindle in number.

I believe that everyone who has MS has MRTCs circulating, whether they can be detected or not. I pointed out one time that a good trivial pursuit question would be to ask how long do memory WBCs last without re-exposure to the enemy they are waiting to defend against. The answer is 72 years. The mechanism to produce MRTCs remains even if we are able to eliminate them as they are produced.

Quote from Lars

With that theory in mind, it would be impossible to judge every positive or negative test without interviewing every patient as to their condition at the time of blood retrieval.



An attack may occur when the number of MRTCs reaches a disease threshold or when the body is triggered to produce extra MRTCs. Many times in the past, I though I was having an attack, but it turned out to be a case of heightened symptoms, thus the 4-day rule.

I think a questionnaire would be useful, but difficult to design so that the responses would differentiate between an attack and increased symptoms. With Tovaxin, the patient will need to be monitored regularly. The interval between blood tests and a bag of blood for new vaccine will probably be as individualized as the vaccine.

If someone waited until they were having an attack to get some vaccine. The vaccine would arrive after the attack was over. First there would be the test for the presence of MRTCs. Then a bag of blood would be drawn, and from start to vaccine would probably be 14 weeks.

The temperature has cooled down enough for me to do some things outside. I am getting ready to go to Wisconsin with my brother on Friday. We get one TV station and no Internet. I may pop into a place with WiFi, but I will be mostly gone until after the 4th of July.
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.
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Postby Lars » Mon Jun 04, 2007 3:05 pm

Bob and Tim,
Mainly I go with the easiest and most obvious theory so I don't have to type so much.
Tim,
As usual your thoughts are well thought out and sensible. Have a good trip. By the way, what place on earth is 72 degrees year round, we all may end up there.
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Postby Lyon » Mon Jun 04, 2007 4:23 pm

IHaveMS-com wrote:Quote from Bob
I will say that when I was reading through your last posting it did flash through my mind that this might have something to do with whatever is behind the relapsing/remitting aspect.

The name relapsing remitting describes the nature of the disease. I usually refer to the action of RRMS, as waxing and waning, like the phases of the moon. You can think of the full noon as an attack and a moonless night as a remission.

SPMS no longer have moonless nights. I assume the MRTCs still wax and wane, but they never sufficiently decrease in number to the point where the body’s repair mechanism can provide enough restoration for the patient to regain some of what had been lost during an attack.

The body’s does not seem to have any defense against autoimmune diseases. With self-reactive cells, the body produces them and is not able to realize that they are destructive. In the case of MS, the oligodendrocytes, which repair myelin damage, are what bring back some lost function. Their action is an important part of the remission in RRMS. If you can bring the number of MRTCs down to near zero, the body will try to repair itself.
Hi Tim,
I can't disagree with anything you said. In fact I highly agree with some of it. What I wasn't able to tell was if you were agreeing, disagreeing or commenting on what I said, or more specifically, I didn't read anything contrary to the fact that the mrtc's might also wax and wane but are always present to the point that damage/increased disability continues.

To put my main interest as a direct question...do you have any idea why the researchers focused on mrtc's being masked rather than assuming that they just are a lower levels, therefore harder to isolate at times?

Lars wrote:Mainly I go with the easiest and most obvious theory so I don't have to type so much.
Which probably proves that you are the wisest of the three of us! I like the saying "better to leave your mouth closed and let everyone wonder if you are a fool than to open your mouth and remove all doubt". Too bad I don't heed it :oops:
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Postby akaheather » Wed Jun 06, 2007 8:20 pm

Hey Guys!

I saw my neuro yesterday after getting my MRI. (I'm done with the injections as of early may.)

I just wanted to let you know that my neuro thought that Opexa would be releasing interim data for the Phase II study to the FDA in September. I assume this will be something we will have access to?

Also, during the last visit I told him about our site. He checked it out and was impressed. So Bob, let me know if you need a new best friend. :wink:

Heather
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Postby Lyon » Wed Jun 06, 2007 8:25 pm

akaheather wrote: Also, during the last visit I told him about our site. He checked it out and was impressed. So Bob, let me know if you need a new best friend. :wink:
Ha! People tire of me quickly. I'm always in the market for new best friends!

Thanks Heather :D
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Postby Lyon » Fri Jun 08, 2007 3:06 pm

akaheather wrote: I just wanted to let you know that my neuro thought that Opexa would be releasing interim data for the Phase II study to the FDA in September. I assume this will be something we will have access to?
Hi Heather,
I think that information almost certainly is going to either start out or will quickly become public knowledge but if not, and if we can find out when it's released, we'll get our hands on it somehow!

Sorry I originally missed that question. My mind was on having a rich neuro buddy to buy rounds of Labatt's for robbie and I after MS is cured!
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Postby IHaveMS-com » Fri Jun 08, 2007 9:18 pm

What happen to not posting twice in a row.

The data will be released closer to the end of the year. It will be a press release, and I am sure someone will post it the same day.

I am off to Wisconsin.
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.
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Postby Lyon » Fri Jun 08, 2007 9:41 pm

IHaveMS-com wrote:What happen to not posting twice in a row.
The data will be released closer to the end of the year. It will be a press release, and I am sure someone will post it the same day.
I am off to Wisconsin.

I knew that statement about not liking to post twice in a row was going to haunt me!
I figured you'd probably be in Wisconsin already and not leaving in the middle of the night!

Have a good trip and be merciless to the fish.
Bob
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Postby akaheather » Sat Jun 09, 2007 7:52 pm

I mentioned to him (the neuro) that I thought that it would be closer to November and he looked at me strangly and said that no, it would be in September.

I can't remember what post it was that said November in the first palce, but I know I read that here. I guess we may just have to wait and see, but frankly I'd be happy to hear some news a.s.a.p.

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Postby Lyon » Sat Jun 09, 2007 8:55 pm

Study start: May 2006; Expected completion: December 2007
Hi Heather,
Might it have been an old post which said November? Although Opexa filled the trial participants pretty quickly, I don't think the trial got underway as quickly as they originally intended. Just guessing.
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Postby Loobie » Sun Jun 10, 2007 6:40 pm

November sounds about right. I'm apparently number 10 of the 300, and my year is up in late November. So I guess it would make sense that early November would be maybe "ground zero" for Phase IIb. I don't see how they would have enough data to release unless it's an interim release. I really have no clue since I don't really read trials enough to know how they are conducted (I'm just a participant :P ) but that is what I would surmise.
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Postby Lars » Sun Jun 10, 2007 7:18 pm

Hey All,
I'm bit confused, are we talking about the 11b trial? I'm not sure how the data could possibly be available by then. I haven't even started injections and I can't imagine that I am alone at the end of the line. Didn't the trial only just recently fill up? Math was never my strong point, but a year long study from the time I signed up (if indeed it is from sign up and not 1st injection) puts it at about next next May for me. It would have to be interim data or we must be talking about the 11 study. I hope I didn't fall asleep and miss a year.
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