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Alba Therapeutics Announces Positive Celiac Disease Trial Results

Celiac.com 03/14/2006 - Alba Therapeutics Corporation announced today successful completion of Phase Ib proof-of-concept studies for its lead compound, AT1001. In a 21-patient cohort of celiac disease sufferers, the oral administration of AT1001 versus placebo control induced a significantly positive result in the trials primary target endpoint.

"We anticipated a strong signal, however, the magnitude of the response surpassed our expectations," stated Blake Paterson, M.D., President and CEO of Alba. "We are particularly excited, as to the best of our knowledge this is the first demonstration of a desired and systemic immunological effect resulting from a physiological event at a mucosal surface."

AT1001 is an antagonist to the zonulin system -- a signaling pathway discovered by Alessio Fasano, M.D., Professor of Pediatrics, Medicine and Physiology at the University of Maryland School of Medicine, and the basis of Albas extensive intellectual property portfolio.

About Zonulin

Zonulin is a signaling protein that transiently and reversibly opens the tight junctions ("tj") between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Zonulin appears to be involved in many diseases in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of autoimmune diseases.

About Celiac Disease

Celiac disease (CD) 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, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. The only current treatment for celiac disease 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 drug delivery adjuvants based on the zonulin pathway. Albas lead molecule, AT-1001, is targeted towards the treatment of celiac disease and other auto-immune illnesses.