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Second Phase 2 Trial Of Telotristat Etiprate Shows Positive Results In Carcinoid Syndrome

THE WOODLANDS, Texas, Oct. 12, 2012 /PRNewswire/ --  Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line data from a recently completed Phase 2 study in carcinoid syndrome with telotristat etiprate. Results from the trial will be presented at the North American Neuroendocrine Tumor Society on Saturday, October 13, 2012 in San Diego, California.

Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract. It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death. Carcinoid syndrome has been linked to excess production of serotonin by metastatic tumor cells. Telotristat etiprate is an oral investigational new drug designed to treat carcinoid syndrome by reducing serotonin production in patients with metastatic carcinoid tumors.  Telotristat etiprate has Fast Track status and Orphan Drug designation from the Food and Drug Administration, and Orphan Drug designation from the European Medicines Agency.

The primary efficacy endpoint of the trial was the reduction of bowel movements from baseline in patients with metastatic carcinoid syndrome who were refractory to or could not tolerate somatostatin analog therapy. Patients experienced a 46.4% median reduction from baseline at week 12, with the number of daily bowel movements steadily decreasing over time. All observed changes from baseline were statistically significant at p < 0.001. This change corresponded with an increased proportion of patients reporting adequate relief of their carcinoid symptoms, a global assessment which also improved over time, with 75% of the patients with data at week 12 reporting improvement. Clinically relevant decreases from baseline were likewise seen for a number of key secondary endpoints, including statistically significant improvements in stool consistency (p < 0.001) and trends of reductions in abdominal pain (p=0.09) and the number of cutaneous flushing episodes (p=0.052). The median percentage reductions from baseline of urinary 5-HIAA at weeks 8 and 12 were 68.3% (p=0.019) and 72.7% (p=0.031), respectively. Urinary 5-HIAA is a biomarker of serotonin synthesis and is of key interest in these patients.

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