Currently in Tovaxin IIB Clinical Trial

If it's on your mind and it has to do with multiple sclerosis in any way, post it here.

Postby Lyon » Wed Nov 22, 2006 9:11 am

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Postby ewizabeth » Wed Nov 22, 2006 9:59 am

Same here, Napay. It is hard to tell what the good numbers come from in the previous small trials. And that is why this is a phase IIb trial with a larger group.

To see if they can have the same good results with ~ 150 patients. There must be something good happening I hope? Hence the continuation of studying it, and with a placebo group to help verify the good results of those on the real thing. (Did I say that right?)
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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clear

Postby notasperfectasyou » Wed Nov 22, 2006 10:03 am

Lyon wrote:I've got the same concerns napay but it seems that we are going to have to wait and see.
Bob


I just want to be clear - I'm not being a naysayer. I really hope and pray that this is a real deal. I personally dislike the way folks critisize things without offering an alternative. In this case, I'm just wanting clarity about that the therapy has done. I realize that we're not going to get to see the data and I think folks ought to get a shot as seeing it if they're going to participate in the study. Have a Great Thanksgiving everyone! napay
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Re: clear

Postby Lyon » Wed Nov 22, 2006 1:41 pm

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Postby CureOrBust » Thu Nov 23, 2006 1:28 am

notasperfectasyou wrote:ok. I'm a numbers guy. what does this really mean? It sounds like a comparison to me. They are measuring relapse reduction - is that number of exaserbations compared to prior year? Given what this therapy is saying it does, I'd prefer to see something like 90% of patients had NO relapses. The implication is that folks had exaserbations, it's just that they had fewer of them.

Going from MEMORY. In the trial where the 90% was quoted, one person had one relapse. I dont know how many people or how long the trial was for. ... see link for abstract ... It would also appear that the relapse occured in the lower dosage group.
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Postby ewizabeth » Thu Nov 23, 2006 6:16 am

My appointment is tomorrow. The nurse called to remind me. I asked if they would do the blood draw for the MRTC's tomorrow. She asked someone, and then said it isn't likely... They'll just go over the consent form, if I decide to sign on, they'll do the exams and the initial blood tests to rule out other things as a precaution. Then I'll stop Copaxone for a month, and go back to have the blood drawn for the MRTC part of it.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby Lyon » Thu Nov 23, 2006 9:05 am

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Postby connieb » Thu Nov 23, 2006 2:12 pm

Getting back to a question previously asked somehwere, was anyone in the current trial given information form Opexa on what is the percentage of people from whose blood they are able to isolate whatever they need for the vaccine? (sorry for the lack of proper verbiage there, I fulfilled my college science requirement with Astronomy 101! :) )
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Postby Lyon » Thu Nov 23, 2006 4:04 pm

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Re: Currently in Tovaxin IIB Clinical Trial

Postby NHE » Sun Nov 26, 2006 4:17 am

Lyon wrote:The nurse did mention in passing that having ANY residual steroids in your blood before MRTC testing had been greatly reducing success in isolating MRTC's which they considered good reason to strictly adhere to the no steroid use in the previous 60 (90?) days. I thought that was an interesting tidbit and it made me wonder if steroids mask MRTCs or eliminate them from the blood somehow?

Corticosteroids, such as prednisone, induce apoptosis in lymphocytes. That is, they induce the white blood cells to die off. It's likely that this reduces the number of myelin reactive T-cells to such a low number that they are difficult to isolate.

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Re: Currently in Tovaxin IIB Clinical Trial

Postby Lyon » Sun Nov 26, 2006 8:06 am

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Postby ewizabeth » Sun Nov 26, 2006 8:18 am

Well, I was still using Nasonex (steroid inhaler) until Friday. My appt to get all the tests and blood draws is December 29th. If there is a problem with this, I hope they'll call and tell me before I get there, I'd rather move the appt back another month if necessary. Somehow I doubt it will be a problem though, it's a tiny, localized dose, how much can get in the bloodstream from that?

On second thought, I think I'll call and ask my doctor, since he said I could call with any question I have...
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Steroids/Tovaxin

Postby Lyon » Sun Nov 26, 2006 8:57 am

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Re: Steroids/Tovaxin

Postby ewizabeth » Sun Nov 26, 2006 9:02 am

Lyon wrote:I imagine isolating the T cells is expensive enough that they want the odds of success to be as good as possible.


Yes, I think you're right Bob. I'll call in the morning.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby dignan » Sun Nov 26, 2006 9:17 am

Bob,
You got me thinking about steroid studies, so I checked it out a little. There are a couple of fairly recent studies on longer-term usage.



A phase II study of i.v. methylprednisolone in secondary-progressive multiple sclerosis.

Neurology. 1998 Jul;51(1):239-45.
Comment in: Neurology. 1999 Mar 10;52(4):896-7.
Goodkin DE, Kinkel RP, Weinstock-Guttman B, VanderBrug-Medendorp S, Secic M, Gogol D, Perryman JE, Uccelli MM, Neilley L.
UCSF/Mt. Zion Multiple Sclerosis Center, San Francisco, CA 94115, USA.

OBJECTIVE: To compare the tolerability and efficacy of two doses of i.v. methylprednisolone in patients with secondary-progressive MS.

METHODS: I.v. methylprednisolone administered in high or low dose every other month for up to 2 years to 108 patients with secondary-progressive MS.

RESULTS: No significant difference in efficacy with the primary outcome, a comparison of the proportions of patients in each treatment group who experienced sustained progression of disability. A relative treatment effect was detected with the high-dose regimen as measured by the preplanned secondary analysis, a comparison of time to onset of sustained progression of disability. Drug-related adverse events were observed more frequently in high-dose recipients but serious drug-related adverse events were uncommon, and cessation of study drug was only required in one patient.

CONCLUSION: The results of the secondary analysis of this study suggest that a phase III trial of corticosteroids for secondary-progressive MS is warranted.

pubmed reference



Monthly intravenous methylprednisolone in relapsing-remitting multiple sclerosis - reduction of enhancing lesions, T2 lesion volume and plasma prolactin concentrations.

BMC Neurol. 2006 May 23;6:19.
Then Bergh F, Kumpfel T, Schumann E, Held U, Schwan M, Blazevic M, Wismuller A, Holsboer F, Yassouridis A, Uhr M, Weber F, Daumer M, Trenkwalder C, Auer DP.
Section of Neurology, Max-Planck-Institut fur Psychiatrie, Munchen, Germany. ThenBerF@medizin.uni-leipzig.de

BACKGROUND: Intravenous methylprednisolone (IV-MP) is an established treatment for multiple sclerosis (MS) relapses, accompanied by rapid, though transient reduction of gadolinium enhancing (Gd+) lesions on brain MRI. Intermittent IV-MP, alone or with immunomodulators, has been suggested but insufficiently studied as a strategy to prevent relapses.

METHODS: In an open, single-cross-over study, nine patients with relapsing-remitting MS (RR-MS) underwent cranial Gd-MRI once monthly for twelve months. From month six on, they received a single i.v.-infusion of 500 mg methylprednisolone (and oral tapering for three days) after the MRI. Primary outcome measure was the mean number of Gd+ lesions during treatment vs. baseline periods; T2 lesion volume and monthly plasma concentrations of cortisol, ACTH and prolactin were secondary outcome measures. Safety was assessed clinically, by routine laboratory and bone mineral density measurements. Soluble immune parameters (sTNF-RI, sTNF-RII, IL1-ra and sVCAM-1) and neuroendocrine tests (ACTH test, combined dexamethasone/CRH test) were additionally analyzed.

RESULTS: Comparing treatment to baseline periods, the number of Gd+ lesions/scan was reduced in eight of the nine patients, by a median of 43.8% (p = 0.013, Wilcoxon). In comparison, a pooled dataset of 83 untreated RR-MS patients from several studies, selected by the same clinical and MRI criteria, showed a non-significant decrease by a median of 14% (p = 0.32). T2 lesion volume decreased by 21% during treatment (p = 0.001). Monthly plasma prolactin showed a parallel decline (p = 0.027), with significant cross-correlation with the number of Gd+ lesions. Other hormones and immune system variables were unchanged, as were ACTH test and dexamethasone-CRH test. Treatment was well tolerated; routine laboratory and bone mineral density were unchanged.

CONCLUSION: Monthly IV-MP reduces inflammatory activity and T2 lesion volume in RR-MS.

Pubmed reference
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