Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientif...(ase is a strict gluten-free diet;however...),Health
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ase 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."
"Alba is excited to be advancing the first therapy for celiac disease
and we are encouraged by these breakthrough findings," said Dr. Francisco
Leon, head of Clinical Research and Development at Alba Therapeutics, Inc.
"These results will be further tested in Phase III clinical trials to
evaluate safety, efficacy, and maintenance of effect of larazotide acetate
in treating celiac disease. In addition, we are excited by early
preclinical study results showing signs of
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