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Results from clinical trial for Celiac treatment
Topic Started: Nov 22 2006, 11:14 AM (264 Views)
I am Vo
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< delurk >

For those who might be interested in the latest news from the Celiac
Symposium...

NEW YORK, Nov. 13 /PRNewswire/

Data presented on November 11th at the XII International Celiac
Disease Symposium in New York City show that when AT-1001, an
investigational oral zonulin receptor antagonist being developed for
treatment of Celiac Disease ("CD"), was assessed in a double blind,
placebo controlled study of CD patients, the product induced a
positive result on the trial's primary endpoint, intestinal
permeability. The objective of the Phase Ib proof of concept study was
to establish the safety, tolerability and effectiveness of single
doses of oral AT-1001 in adult CD patients in remission that are
challenged with a large dose of gluten. Key findings from this Phase
Ib study include:
* Intestinal barrier function was maintained by AT-1001 despite a
supramaximal stimulus with gluten. There was a significant increase in
permeability in placebo recipients but not in AT-1001 recipients
following the 2.5 gram gluten challenge, as determined by urinary
Lactulose-to- Mannitol (L- to-M) ratio.
* AT-1001 was generally safe and well tolerated, and no serious
adverse events were reported.
* AT-1001 plasma concentrations were unmeasureable (< 0.5 ng/ml),
indicating little to no systemic absorption when administered orally.
* The biological effect of AT-1001 persisted beyond the drugs
residence time, suggesting that AT-1001 modulates both persistent leak
and immune activation.
* Symptoms of acute gluten toxicity were inhibited in the AT-1001
arm when compared to placebo.
"AT-1001's inhibitory effect is most likely related to its
capacity to prevent zonulin binding to its receptor on the lining of
the gut, reducing exposure to gliadin and immune activation," stated
Blake Paterson, M.D., Alba's Co-founder and CEO. "We are excited by
the demonstration of a systemic immunological benefit arising from a
physiological event at a mucosal surface of the small bowel, and look
forward to completion of our Phase II clinical trial to further assess
AT-1001's impact in this debilitating disease."

About AT-1001
AT-1001 is an orally administered octapeptide zonulin receptor
antagonist that appears to exert its inhibitory effect on
gliadin-induced tight junction disassembly by blocking putative
zonulin receptors on the luminal surface of the small intestine.
Pretreatment with the peptide fails to inhibit gliadin induced zonulin
release, while administration of zonulin analogues or gliadin in the
presence of AT-1001 fail to significantly affect intestinal
permeability, confirming the effect of the molecule is specific to the
zonulin receptor. AT-1001 is currently under investigation in a
multicenter, double blind, placebo controlled Phase II dose ranging
study to evaluate the safety, tolerability and efficacy of AT-1001 in
79 CD subjects during gluten challenge.

About Zonulin
Zonulin is an endogenous signaling protein that transiently and
reversibly opens the tight junctions between the cells of epithelial
and endothelial tissues such as the intestinal mucosa, blood brain
barrier and pulmonary epithelia. Discovered by Alba's co-founder, Dr.
Alessio Fasano, zonulin appears to be involved in many disease states
in which leakage occurs via paracellular transport across epithelial
and endothelial tight junctions, and thus may play an important
potential role in the treatment of autoimmune and inflammatory diseases.

About Celiac Disease
Celiac disease is a T-cell mediated auto-immune disease that
occurs in genetically susceptible individuals and is characterized by
small intestinal inflammation, injury and intolerance to gluten.
According to the National Institutes of Health, CD affects
approximately 3 million Americans. The only current treatment for CD
is complete elimination of gluten from the diet, which results in
remission for some patients.

About Alba
Alba Therapeutics Corporation is a privately held
biopharmaceutical company based in Baltimore, Maryland. Alba is
dedicated to commercializing disease-modifying therapeutics and
vaccine and drug delivery adjuvants based on the zonulin pathway.
Alba's lead molecule, AT-1001, is targeted towards the treatment of
Celiac Disease and Type 1 Diabetes and other autoimmune diseases.

Contact: Stuart Sedlack, SVP, Corporate Development
Phone: 410-319-0780
E-mail: info@albatherapeuti cs.com
Web site: http://www.albather apeutics. com


</ delurk >
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0613
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wow! i think i understand about five words of that, but i'll pass it along to my mil. thanks!
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zuncompany
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as happy as i am for the celiacs of the world it worries me that all the great new products will go away. As we are gluten free due to allergies and not celiac this drug will not help us.
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