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Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease
Date:11/11/2008

- Milestone Marks the First Time a European Patient with Active Celiac Disease has Enrolled in a Clinical Trial for an Investigational Medication

from Alba Therapeutics -

BALTIMORE, Nov. 11 /PRNewswire/ -- Alba Therapeutics Corporation announced today that for the first time, a European patient with active celiac disease has been enrolled in its clinical trial to investigate a treatment for the disease. Alba has enrolled and randomized the newly diagnosed patient from Spain in an eight-week Phase IIb trial with oral larazotide acetate, a tight junction regulator, for the treatment of patients with active celiac disease (CD). The global multi-center, randomized, double-blind, placebo-controlled study will evaluate the clinical and histological efficacy, safety and tolerability of larazotide acetate in 106 active CD subjects adhering to a gluten-free diet, while assessing improvement in the clinical signs and symptoms of celiac disease.

"These are decisive times for our desire to one day be able to offer our celiac patients a treatment that allows them to live more normal lives," said Dr. Gemma Castillejo, MD, a pediatric gastroenterologist and principal investigator in the study. Dr. Castillejo, a leading European celiac expert from the Sant Joan de Reus University Hospital in Reus, Spain added, "I believe this clinical trial has the potential to be a turning point in the search for treatments for celiac disease."

"This is a major milestone for the celiac community in Europe," stated Francisco Leon, MD, PhD, Vice President, Clinical Development and Medical Affairs of Alba. "This is Alba's sixth human trial with larazotide acetate, and we are excited to be advancing our investigational program for larazotide acetate in this important region of the world."

About Celiac Disease

Celiac disease is an inherited autoimmune disorder where gluten has been identified as the environmental trigger of the disea
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SOURCE Alba Therapeutics Corporation
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