Trial results for BHT-3009

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Trial results for BHT-3009

Postby Frank » Mon Aug 13, 2007 12:48 pm

Its a small, but placebo controled, trial with 30 RRMS and SPMS Patients that was conducted between 2004 and 2006.
No detailed efficiency results are reported here, just a positve trend in MRI parameters.
A Phase-IIb trial, including about 290 MS pateients, is already under way.

The source can be found here.

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby Sandrine » Tue Aug 28, 2007 4:28 am

Phase II was planned to be completed June 2007, according to http://clinicaltrials.gov/ct/show/NCT00382629

For anyone interested in some details:

BHT-3009 is a plasmid (dna molecule) coding for the cDNA of MBP (myelin basic protein). In addition, the dna sequence of the plasmid backbone was "optimized" replacing the immunostimulating CpGs (> DNA = A, T, G, C) by immunoinhibitory GpGs (published http://www.jimmunol.org/cgi/content/ful ... 09c712e358). That should give a synergistic effect...

Here the study results http://archneur.ama-assn.org/cgi/conten ... v1?papetoc

The MRI data is not so impressive (maybe also because of the small number of persons in the study), but I found the FACS (flow cytometer, to sort cells) data quite convincing: It showed a dramatic decrease of MBP-specific T-cell response for weeks.

Sandrine
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Postby Frank » Tue Aug 28, 2007 5:09 am

Sandrine, thank you very much for sharing this interesting article with us! :)

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
Frank
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Posts: 542
Joined: Wed Jan 03, 2007 4:00 pm
Location: Germany


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