Annie Barnes (Site Admin)
_______________________________

Wednesday, November 15, 2006

Alba Therapeutics Presents Data from Positive Phase Ib Clinical Trial at the XII International Celiac Disease Symposium

New York, November 10, 2006

Source - Alba Therapeutics

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."

Discover why Celiac Disease is an Emerging Epidemic

Peter H.R. Green, MD

One in every 100 people in the United States is affected by this autoimmune condition and 97 percent of them are undiagnosed. Discover how this inflammatory condition of the intestines can affect every system in the body and why it is important to get a proper diagnosis.

Peter H.R. Green, MD, is the director of the Celiac Disease Center at Columbia University, a professor of clinical medicine at Columbia's College of Physicians and Surgeons and the author of Celiac Disease: A Hidden Epidemic.

Date & Time: Tue, Nov 28, 2006, 6:30pm
Location: 92nd Street Y, 1395 Lexington Avenue, New York, NY 10128

Tickets are $10; $5 for May Center Members.

To order tickets call 212.415.5700 or visit www92y.org

Tuesday, November 14, 2006

WANTED! DH volunteer for Crossed Grain Case Study

Coeliac UK are looking for a volunteer with DH to act as a short case study for the Crossed Grain Magazine. If you think you can help please contact:

Emma Merrikin
Dietitian
Coeliac UK
Suites A-D
Octagon Court
High Wycombe
Bucks
HP11 2HS

Emma.Merrikin@coeliac.org.uk