Health InsuranceLexicon Initiates Phase 2 Clinical Trial Of LX1032 In Patients With Carcinoid Syndrome
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has initiated a Phase 2 clinical trial of LX1032, the company"s oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. LX1032 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.
In addition to LX1032, Lexicon has three other drug candidates progressing through various stages of clinical development, including LX1031 for irritable bowel syndrome, LX2931 for rheumatoid arthritis, and LX4211 for diabetes.
"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 vice president 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 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.
About LX1032
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 no longer respond to the standard of care under Fast Track designation from the U.S. Food and Drug Administration.
About Carcinoid Syndrome
Carcinoid syndrome is a chronic condition caused by metastatic neuroendocrine tumors that usually originate from the gastrointestinal tract. These tumors secrete large amounts of serotonin, which can cause a variety of symptoms including severe diarrhea and abdominal discomfort. Patients with carcinoid syndrome currently have limited therapeutic options, and the standard of care includes chronic therapy with somatostatin analogues, which are delivered by injection. With current therapy, the gastrointestinal symptoms return over time in the vast majority of patients, hence the need for new agents.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company"s research team. The company has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon"s clinical development of LX1032 and the potential therapeutic and commercial potential of LX1032. This press release also contains forward-looking statements relating to Lexicon"s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management"s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon"s ability to successfully conduct clinical development of LX1032 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon"s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon"s annual report on Form 10-K for the year ended December 31, 2008, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Lexicon Pharmaceuticals, Inc