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Tex and others,
Does anyone know the status of the zonulin blocking drug that Dr. Fasano was working on? I heard from a student recently that one of her professors said the clinical trials were not going well.
Thanks,
Mary Beth
Zonulin blocker
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Zonulin blocker
"If you believe it will work out, you'll see opportunities. If you believe it won't you will see obstacles." - Dr. Wayne Dyer
On July 14, 2011, Alba Therapeutics began soliciting subjects to begin a Phase 2B study.
http://clinicaltrials.gov/ct2/show/NCT01396213
Apparently, they're having trouble with their subjects in the cohort, (maybe they're dropping out because of a relapse of symptoms).
I'm basing that guess on the fact that they recently extended their recruitment period. 
Maybe they're throwing out the data for everyone who relapses, and hoping to find a few subjects with a high tolerance threshold. 
Here's the current study information, showing an expected "primary" completion date, (apparently the completion of recruitment), of July, 2013, and an expected study completion date of November, 2013.
http://clinicaltrials.gov/archive/NCT01 ... 2012_03_15
Originally, the primary completion date was anticipated to be December, of 2012, and the study completion date was anticipated to be March, 2012.
http://clinicaltrials.gov/archive/NCT01 ... 2011_07_15
I can't say that I'm surprised that it's not going well. Remember when they sold an option to Cephalon, for 15 million bucks up front, in February of last year? Evidently they could see the handwriting on the wall. I wondered at the time, why they sold an option on what was potentially a billion dollar idea, for only 15 million bucks.
Tex
http://clinicaltrials.gov/ct2/show/NCT01396213
Apparently, they're having trouble with their subjects in the cohort, (maybe they're dropping out because of a relapse of symptoms).
I'm basing that guess on the fact that they recently extended their recruitment period. Maybe they're throwing out the data for everyone who relapses, and hoping to find a few subjects with a high tolerance threshold. Here's the current study information, showing an expected "primary" completion date, (apparently the completion of recruitment), of July, 2013, and an expected study completion date of November, 2013.
http://clinicaltrials.gov/archive/NCT01 ... 2012_03_15
Originally, the primary completion date was anticipated to be December, of 2012, and the study completion date was anticipated to be March, 2012.
http://clinicaltrials.gov/archive/NCT01 ... 2011_07_15
I can't say that I'm surprised that it's not going well. Remember when they sold an option to Cephalon, for 15 million bucks up front, in February of last year? Evidently they could see the handwriting on the wall.
I wondered at the time, why they sold an option on what was potentially a billion dollar idea, for only 15 million bucks.Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.
Q
This vaccine will reduce the inflammation, not eliminate it, because it only address the three main peptides, (out of almost a hundred peptides that many celiacs react to). IMO, it will probably be more beneficial for true celiacs, (with the DQ2.5 gene), rather than for all of us with non-celiac gluten-sensitivity, (because we don't have that gene).
If I am interpreting this correctly, that means that anyone with gluten-sensitivity, who gets the vaccine, and continues to ingest gluten, will still be at an elevated risk of developing other autoimmune diseases. That little problem obviously won't show up until years after it is approved for use, because it usually takes a long time for enough adverse case studies to trickle in, to verify a trend.
Tex
If I am interpreting this correctly, that means that anyone with gluten-sensitivity, who gets the vaccine, and continues to ingest gluten, will still be at an elevated risk of developing other autoimmune diseases. That little problem obviously won't show up until years after it is approved for use, because it usually takes a long time for enough adverse case studies to trickle in, to verify a trend.
Tex
It is suspected that some of the hardest material known to science can be found in the skulls of GI specialists who insist that diet has nothing to do with the treatment of microscopic colitis.