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October 7, 2008: Tenant News

Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientific


Study Showed Larazotide Acetate Prevented Immunologic Changes Induced by Gluten in Patients with
Celiac Disease
Additional Data Indicates Potential in Treating Inflammatory Bowel Disease

ORLANDO, FL, October 7, 2008/PRNewswire - Alba Therapeutics Corporation presented results from two clinical
studies this week at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting. Data from study
CLIN 1001-004, the first Phase IIa trial conducted in celiac disease and the first to assess the prevention of
immunologic changes in celiac disease, showed that larazotide acetate (AT-1001) successfully demonstrated prevention
of gluten-induced immunologic changes in celiac patients.
Results from the study showed that larazotide acetate is the first pharmacologic agent to prevent changes in blood
mononuclear cell populations (specifically T-reg cells and B Cells) and other markers of immunological change
associated with active celiac disease. This data suggests that larazotide acetate offers potential as a future treatment of
celiac disease.

Results from a second poster presented at ACG showed that larazotide acetate also inhibited the effect of inflammatory
cytokines, including tumor necrosis factor (TNF-α) and interleukin (IL-4) on intestinal epithelial permeability, in vitro,
further suggesting that the product offers potential as a future treatment for inflammatory bowel disease (IBD).
Larazotide Acetate is a novel, non-absorbed peptide currently being studied in Phase IIb trials for the treatment of celiac
disease. Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been
granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA) for this indication.
Celiac disease affects approximately one percent of individuals in the United States and Europe, or approximately 6.5
million individuals. The only accepted management for the disease is a strict gluten-free diet; however, the response to
therapy is poor or incomplete in up to 30 percent of patients. These facts suggest that there is a need for therapeutic
modalities beyond dietary modification.

Related data presented in a third poster at ACG include results from a qualitative study conducted to investigate the
validity of the Gastrointestinal Symptom Rating Scale (GSRS) in patients with celiac disease. The GSRS is a validated
measure used in clinical trials for irritable bowel syndrome and peptic ulcer disease. GSRS has been utilized in studies
to assess larazotide acetate, including CLIN 1001-004 and CLIN 1001-006. Results from the poster presentation suggest
that certain subscales of the GSRS may have relevance for use in establishing the efficacy of novel treatments for celiac
disease. This is the first time the validity of the GSRS clinical scale has been studied in celiac disease to assess efficacy
of treatments.

“There are currently no products approved by the FDA to treat celiac disease and a clear need exists for a therapeutic
option,” said Daniel Leffler, MD, gastroenterologist, Beth Israel Deaconess Medical Center and one of the lead
investigators for CLIN 1001-004. “This study showed that larazotide acetate prevented immunologic changes induced
by gluten in patients with celiac disease. In addition, studies to establish the validity of scales such as GSRS are an
important step forward in the development of effective treatments for celiac disease.”

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