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Phase 2 Trial of Lexicon's LX1032, Telotristat Etiprate, Shows Positive Results in Carcinoid Syndrome
Date:8/9/2011

ate was well tolerated, and adverse events in the study were usually mild to moderate with similar frequencies overall between treatment groups and placebo. Five telotristat etiprate patients achieved clinical responses characterized by reductions of at least 30% in the number of bowel movements per day for two weeks or more during the study. Six telotristat etiprate patients reported adequate relief of carcinoid symptoms at the end of the study. There were nine telotristat etiprate patients with a complete biochemical response defined as a reduction of at least 50% in urinary 5-HIAA, a biomarker of serotonin synthesis. No patients on placebo experienced a clinical response, adequate relief of symptoms, or biochemical response during the study. The difference between telotristat etiprate and placebo in bowel movement frequency ranged between 1.6 and 2.9 bowel movements/day across telotristat etiprate doses, all favoring telotristat etiprate treatment. Also of note, all eligible patients elected to continue treatment with telotristat etiprate under an extension protocol.

Preliminary data were also reported from a separate, ongoing, open-label, single-arm study of telotristat etiprate in Europe. To date, 5 out of 6 patients with refractory carcinoid syndrome have experienced sustained reductions of at least 30% in bowel movement frequency when treated with telotristat etiprate. Two of these responses were within the first 4 weeks of therapy, while three more occurred between 4 and 8 weeks of treatment under the 12-week protocol.

"The Phase 2 data clearly show a reduction in bowel movements and symptom relief in a population that has exhausted all standard-of-care treatment options," said Dr. Pablo Lapuerta, senior vice president and chief medical officer at Lexicon. "The Phase 2 data are also consistent with preliminary results from the European study, where there appear to be some early responses a
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SOURCE Lexicon Pharmaceuticals, Inc.
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