zed, 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 vice president 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."
LX1032 is being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.
LX1032 was discovered and developed at Lexicon to reduce serotonin production by inhibiting tryptophan hydroxylase (TPH), a key enzyme in the synthesis of serotonin. Excessive levels of serotonin have been implicated in symptoms associated with carcinoid syndrome. Serotonin's breakdown product, 5-HIAA, is a biomarker used in the diagnosis of the condition. In preclinical studies, LX1032 reduced peripheral serotonin and urinary 5-HIAA levels in several different species without affecting serotonin levels in the brain. In Phase 1 clinical studies, LX1032 reduced serotonin levels and urinary 5-HIAA in healthy volunteers consistent with preclinical results. LX1032 is being developed for the treatment of gastrointestinal symptoms associated with carcinoid syndrome in patients who
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