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NPS Reports Successful GATTEX(TM) Extension Study
Date:3/17/2008

the third quarter of this year."

Phase 3-Extension Study Design

The extension study enrolled 65 of the 71 patients (91%) patients who had previously completed a Phase 3 clinical trial that evaluated low-dose GATTEX (0.05 mg/kg/day), high-dose GATTEX (0.10 mg/kg/day) and placebo for PN-dependent SBS patients. Patients who were already receiving GATTEX in the Phase 3 study continued on their dose for an additional 28 weeks for a total of 52 weeks of therapy. Patients who were receiving placebo in the initial Phase 3 clinical study were randomized in the blinded extension study to receive either a low dose of GATTEX (0.05 mg/kg/day) or a high dose of GATTEX (0.10 mg/kg/day) for 28 weeks of therapy.

Previously Reported Phase 3 Results

In October 2007, NPS reported positive top-line results from the company's Phase 3 study of GATTEX in which 83 patients with short bowel syndrome (SBS) received either a low dose of GATTEX (0.05 milligrams/kilogram/day), a higher dose (0.10 mg/kg/day) or placebo. The clinical efficacy endpoint of the study was a reduction in PN of at least 20% comparing baseline to weeks 20 to 24, measured as a graded response to capture reductions up to 100%. In an intent-to-treat analysis, forty-six percent (46%) of patients receiving the lower dose of GATTEX (N=35) responded and achieved a significant reduction in PN compared to placebo (p=0.007). Twenty-five percent (25%) of patients receiving the higher dose of GATTEX (N=32) responded and showed a trend in the difference between the treatment group and placebo, but this did not reach statistical significance (p=0.161). Two low-dose patients gained independence from and discontinued PN by week 16 and a third high-dose patient discontinued PN at the end of treatment. The study's criteria for conducting the statistical analysis of the primary endpoint required that the results for the high-dose group show statistical significance before the results of the low-dose group could
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SOURCE NPS Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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