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Clinical Benefits Demonstrated with Low-Dose GATTEX(TM) in Phase 3 Short Bowel Syndrome Study
Date:10/11/2007

nue our current exploration of GATTEX in other indications with high unmet needs, including chemotherapy-induced GI mucositis and necrotizing enterocolitis."

There are several hypotheses that may explain the higher response in the low-dose group versus the higher-dose group. One theory is that, at higher doses, GLP-2 suppresses appetite and it is possible that patients on the higher dose consumed fewer calories from food and thus did not decrease their PN regimens. A second hypothesis is that GLP-2 exerts various dose-dependent effects and may act by increasing nutrient absorption at low-doses while higher doses of GLP-2 may have a greater effect on mucosal and epithelial regeneration.

Dr. Daniel Drucker, director, Banting and Best Diabetes Centre at the University of Toronto and the scientist who discovered the role of GLP-2, commented, "Recently published animal studies demonstrate that lower doses of GLP-2 can enhance nutrient absorption through enhancement of mechanisms promoting nutrient transport across the gut epithelium and via improved intestinal cell survival, while higher doses of GLP-2 can result in mucosal regeneration. These observations suggest that lower doses of GATTEX may have the greatest potential for effectively treating short bowel syndrome by improving nutrient absorption, while higher doses of GATTEX may have the greatest potential for effectively treating other gastrointestinal disorders where mucosal regeneration may be more important."

Study Design and Top-Line Results

This multicenter, double-blind, international Phase 3 trial was designed to evaluate the efficacy, safety, tolerability and pharmacokinetics of GATTEX compared with placebo in patients with parenteral nutrition (PN)-dependent short bowel syndrome. Eighty three (83) patients who were enrolled in the trial were randomly assigned to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of GATTEX per kilogram of body weight or a plac
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SOURCE NPS Pharmaceuticals, Inc.
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