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

THE WOODLANDS, Texas, Aug. 9, 2011 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced positive, top-line proof-of-concept data from its recently completed Phase 2 study in carcinoid syndrome with LX1032, telotristat etiprate. 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. Symptoms of carcinoid syndrome have been linked to excess production of serotonin by metastatic tumor cells. Telotristat etiprate is designed to reduce serotonin production.

"Telotristat etiprate is our third drug candidate to demonstrate proof of concept in patients in Phase 2," said Dr. Arthur T. Sands, Lexicon's president and CEO. "Based on the positive results of this U.S. study, as well as encouraging observations from our clinical trial in Europe, we intend to discuss a Phase 3 development plan for carcinoid syndrome with the FDA."

The randomized, double-blind, placebo-controlled study was conducted in the United States in 23 patients with carcinoid syndrome who were refractory to currently available therapy. Patients in the study had metastatic carcinoid disease and were experiencing an average of about six bowel movements per day at baseline. Patients received either placebo (n=5) or one of four doses of telotristat etiprate (n=18) daily for 28 days. The primary endpoint of the study was safety and tolerability. Efficacy measures included change in bowel movement frequency, relief of symptoms, and reduction in serotonin synthesis.

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SOURCE Lexicon Pharmaceuticals, Inc.
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