Lexicon Files Investigational New Drug Application For LX1032 As A Potential Treatment For Carcinoid Syndrome

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 22 Dec 2007 - 0:00 PDT

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Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for LX1032, an oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. The initial Phase 1 clinical trial of LX1032 is planned as a double-blind, randomized, placebo-controlled, ascending single-dose study in healthy volunteers. This study is designed to evaluate the safety, tolerability, and pharmacokinetics of LX1032. Lexicon expects to initiate clinical trials with LX1032 following FDA review.

"We believe LX1032 has the potential to be an important new therapy in an area of high unmet medical need," said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. "LX1032 may offer important benefits to patients with carcinoid syndrome, who have very limited treatment options."

Carcinoid syndrome is the result of metastatic carcinoid tumors that usually originate from enterochromaffin cells in the lining of the gastrointestinal tract. These tumors secrete large amounts of serotonin, which causes a variety of symptoms that often includes severe diarrhea and abdominal discomfort. Carcinoid tumors are a type of neuroendocrine tumor and, according to the American Cancer Society, about 11,000 to 12,000 neuroendocrine tumors and neuroendocrine cancers are diagnosed each year in the United States. About 10% of people with carcinoid tumors will develop carcinoid syndrome.

The target for LX1032 was identified through the Genome5000(TM) project, Lexicon's program to identify the function of 5,000 druggable genes in the human genome. LX1032 was developed at Lexicon as a potent inhibitor of tryptophan hydroxylase (TPH), a rate-limiting enzyme in the synthesis of serotonin. In preclinical studies, LX1032 was able to reduce peripheral serotonin in several different species without affecting serotonin levels in the brain. LX1032 is Lexicon's second compound to target TPH and, unlike LX1031, which acts locally within the gastrointestinal tract, was designed to act systemically.

LX1032 is being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.

About Lexicon

Lexicon is a biopharmaceutical company focused on the discovery and development of breakthrough treatments for human disease. Lexicon currently has development programs underway for such areas of major unmet medical need as irritable bowel syndrome, cognitive disorders, and autoimmune diseases. The company has used its proprietary gene knockout technology to discover more than 100 promising drug targets and create an extensive pipeline of clinical and preclinical programs in the therapeutic areas of diabetes and obesity, cardiovascular disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic disease. To advance the development and commercialization of its programs, Lexicon is working both independently and through collaborators including Bristol-Myers Squibb Company, Genentech, Inc. and N.V. Organon. For additional information about Lexicon and its programs, please visit http://www.lexpharma.com.

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, 2006, 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.
http://www.lexpharma.com