Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced that it has received Fast Track status from the US Food and Drug Administration (FDA) for development of LX1032, an orally-delivered small molecule drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. LX1032 is one of four programmes in human clinical trials as part of Lexicon's 10TO10 programme.

"Fast Track status can accelerate the development and expedite the review of LX1032," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer at Lexicon. "The FDA recognizes the serious unmet medical need of patients with carcinoid syndrome who no longer respond to standard care and the potential benefits that LX1032 could have for those suffering from this disease."

Having completed a single-dose phase 1a clinical trial, Lexicon will initiate a multi-dose phase 1b clinical trial of LX1032 in June 2008. The phase 1b trial is a randomized, double-blind, ascending multiple-dose study designed to evaluate the safety and tolerability of LX1032 in approximately 40 healthy volunteers. Lexicon expects data from the Phase 1b clinical trial before the end of the year. Results from this study will be used to support the exploration of potentially therapeutic doses in patients with carcinoid syndrome in accordance with its Fast Track status.

"Lexicon's drug development strategy includes targeting indications for Fast Track status to advance potential medical breakthroughs to market," said Philip M. Brown, M.D., J.D., senior vice president of clinical development at Lexicon. "Gaining Fast Track status for LX1032 is an important step forward for our development plan. We believe that LX1032 may be an important new therapy to treat patients with carcinoid syndrome who have no other treatment options."

Lexicon recently completed an initial phase 1a clinical trial of LX1032, a double-blind, randomized, placebo-controlled, ascending single-dose study in healthy volunteers. The study was designed to evaluate the safety, tolerability, and pharmacokinetics of LX1032 and provided the basis for advancing to the multiple dose study. Lexicon is currently awaiting the analysis of final results from this trial.

Clinical development of LX1032 is being funded through a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.

Carcinoid syndrome is a chronic condition that is the result of metastatic neuroendocrine tumours that usually originate from enterochromaffin cells in the gastrointestinal tract. These tumours secrete large amounts of serotonin, which can cause a variety of symptoms including severe diarrhoea and abdominal discomfort.

According to the American Cancer Society, about 11,000 to 12,000 neuroendocrine tumours and neuroendocrine cancers are diagnosed each year in the United States. 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. Lexicon's Fast Track designation was granted specifically to LX1032 for the treatment of gastrointestinal symptoms associated with carcinoid syndrome in patients who no longer respond to the standard of care.