Lexicon Initiates Phase 2 Clinical Trial of LX1032

THE WOODLANDS, Texas -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) has initiated a Phase 2 clinical trial of LX1032, the company's oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. The drug is designed to reduce serotonin production in patients with metastatic carcinoid tumors. Elevated levels of serotonin contribute to the gastrointestinal and possibly other symptoms experienced by these patients.

"This is an important study, designed to evaluate LX1032's effect on the gastrointestinal symptoms experienced by patients with carcinoid syndrome who have become refractory to current treatment options," said Philip M. Brown, M.D., J.D., Senior V.P. of Clinical Development at Lexicon. "We are encouraged by the clinical results obtained to date in which LX1032 demonstrated potent reductions in serotonin production in healthy volunteers."

The Phase 2 clinical trial is designed as a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1032 and its effects on symptoms associated with carcinoid syndrome. The study will include up to 28 patients with carcinoid syndrome who are symptomatic despite treatment with currently available therapy. Up to four dose levels may be evaluated in a serial ascending fashion. Once an optimal or maximal dose is identified, additional patients will be added to confirm clinical observations.

"The clinical trial will be conducted at multiple cancer centers in the United States," said Brian P. Zambrowicz, Ph.D., Executive V.P and Chief Scientific Officer at Lexicon. "The clinical trial sites will include The University of Texas M.D. Anderson Cancer Center in Houston, Texas; the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida; and Hematology Oncology Services of Little Rock, Arkansas."