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tovaxin phase III

Posted: Thu Jan 08, 2009 2:34 am
by vanessa1973
Hi,
I am an italian girl, i was diagnosed in 1999.
I would like to know when Tovaxin will end Phase II trial.
Does someone know if this drug will start phase III?
And when? Do you think there will be some centre in Europe starting phase III?
thank you for your reply!!

Posted: Thu Jan 08, 2009 5:45 am
by daverestonvirginia
Sorry to let you know, looks like it is over for Tovaxin. The phase II trial was ended, no plans for a phase III. Lots of good things out there happening with MS treatment development, but it is a numbers game, for every success there are things which do not work out.

Posted: Thu Jan 08, 2009 5:52 am
by CureOrBust
lets not forget sheba medical centres vaccine. Which IS in Phase III

"T-Cell Vaccination (aka TCV-01-002) (Sheba Medical Center)" on Dignans list

Posted: Thu Jan 08, 2009 8:19 am
by Lars
Cure,
Since you brought it up....Shebas program has flown a bit under the radar here in Tovaxin land, at least for me. How similar/different is their protocol? The question for me would be, if they are similar treatments wouldn't the obvious route for Tovaxanites be to ride that horse rather than resurrect Tovaxin?
Thanks,
Lars

Posted: Thu Jan 08, 2009 12:38 pm
by JanethePain
Lars wrote:Cure,
Since you brought it up....Shebas program has flown a bit under the radar here in Tovaxin land, at least for me. How similar/different is their protocol? The question for me would be, if they are similar treatments wouldn't the obvious route for Tovaxanites be to ride that horse rather than resurrect Tovaxin?
Thanks,
Lars
Seems to me that the inclusion/exclusion criteria for this stuff would eliminate every MS patient that I've ever come across:

Inclusion criteria:

* Age: 15 - 50 years.
* Three months within the acute onset of neurological symptoms suggestive of the first attack of multiple sclerosis.
* Diagnosis of CPMS C3 (Poser criteria).
* Positive brain MRI according to Fazekas criteria.
* Negative pregnancy test and use of effective contraceptive for female patients who are sexually active.
* Signed written informed consent.

Exclusion criteria:

* Blood tests suggestive of other autoimmune diseases.
* Known allergic reactions to MRI contrast media.
* A clear regression of the neurological symptoms after the first attack that suggests a primary-progressive course.
* Corticosteroid treatment in the previous 4 weeks (28 days).
* Previous treatment with immunosuppressive medications such as cyclophosphamide, azathioprine, methotrexate, mitoxantrone or cyclosporine.
* Previous treatment with interferon beta 1a or 1b, copolymer-1, IVIg, plasmapheresis.

Posted: Thu Jan 08, 2009 1:31 pm
by Loobie
Sounds like they want "MS virgins" :lol:

Posted: Thu Jan 08, 2009 3:49 pm
by Lars
3 months from onset? Most people aren't even diagnosed in that amount of time. I think I qualify on every other point.
Lars

Posted: Thu Jan 08, 2009 5:58 pm
by CureOrBust
Wait a sec, I thought "3 months from first attack" would place this as a prevention treatment for people with CIS, from progressing to MS? Not as a treatment for MS?

And Lars, I know only what I have found here at ThisIsMS on Sheba (ie what Dignan has found :)).

From vague memory, it involves some of the people who originated Tovaxin. But do not quote me on that.

tovaxin is over?

Posted: Sat Jan 10, 2009 2:42 am
by vanessa1973
Tovaxin is over...but I can't understand why...
It semmed to be a very promising drug, what have happened?
Maybe Opexa therapeuticsy has got any troubles?
Do you think there is hope to start phase III, perhaps by some other company?
As dor Sheba, I have read that they made the vaccine only with 2 pepides, and it is not as effective as Tovaxin, is it true?

Posted: Sat Jan 10, 2009 7:26 am
by Loobie
For me anyway, Tovaxin was like salline. It did nothing and I had relapses while on it. I do believe that it was effective for some though, but they simply didn't reach their primary endpoints of the study, and no venture capitalist is going to keep funding a program that doesn't reach it's goals.

Posted: Sat Jan 10, 2009 8:22 am
by patrickm
My doc says that to him "there is no doubt that this vaccine is effective" (for everybody but Lars, the 1%er).

I will be shocked if it is not bought for a song by a large pharma and goes to Phase III. When that happens, who knows? But I expect it at some point.

I will not die holding my breath for that to happen though, especially with my decreased cardio fitness.

Posted: Sat Jan 10, 2009 11:37 am
by Lars
Patrick,
1%er? Wait a minute, are you talking about my mental capacity, sexual prowess, overall life effort or ? I can probably find some willing to back up all theories. Remember, I am not a good gauge for Tovaxins effectiveness. One year of placebo and only 2 actual injection visits in the extension. Lou may a better study. I am now going to prove the 1%er theory as it relates to door #1, mental capacity. I have felt better with no "major" flares since 2 months before my first real injection (last Oct) almost exactly the same time I had a food allergy test and eliminated eggs from my diet, I was apparently highly allergic. I ate a LOT of eggs. So, obviously the hundreds of paths and trials are misguided. It boils down to eggs (get it).
Take Care,
Lars

Posted: Sat Jan 10, 2009 5:41 pm
by Lyon
oo

Posted: Sun Jan 11, 2009 7:35 am
by Lars
Bob,
I have been convinced of the "leaky gut" connection for years. Are your worms supportive of that? Oh, by the way when you say the "guy" will have them ready soon I have a vision of someone selling in a back alley. Are we going to jail for this?
Take Care,
Lars

Posted: Sun Jan 11, 2009 9:20 pm
by Lyon
oo