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. Carcinoid syndrome is a result of these tumors, which secret large amounts of serotonin that can cause severe diarrhea and abdominal discomfort. There are limited therapeutic options, and the gastrointestinal symptoms usually return over time, prompting biotechnology companies to discover new agents.
Lexicon Pharmaceuticals Inc. (Nasdaq: LXRX) is one such company looking to give patients symptomatic relief. The company today announced it has received Fast Track status from the U.S. Food and Drug Administration to accelerate the development of LX1032, an orally-delivered drug candidate for gastrointestinal symptoms associated with carcinoid syndrome.
“Fast Track status can accelerate the development and expedite the review of LX1032,” Arthur T. Sands, M.D., Ph.D., president and CEO of Lexicon stated in the press release. “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.”
The completion of the single-dose phase 1a clinical trial will allow Lexicon to initiate a multi-dose phase 1b clinical trial of LX1032 in June 2008. The trial will involve the study of 40 healthy volunteers, administered multiple doses to evaluate their safety and tolerability.
LX1032 is one of four programs in human clinical trials as part of Lexicon’s 10TO10 program; carcinoid syndrome is the first therapeutic indication for which Lexicon has obtained Fast Track status, reiterating the discomfort those suffering with carcinoid syndrome feel and the importance of new agents and the FDA’s Fast Track designation.
“Lexicon’s drug development strategy includes targeting indications for Fast Track status to advance potential medical breakthroughs to market,” Philip M. Brown, M.D., J.D., senior vice president of clinical development at Lexicon stated in the press release. “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.”
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