THE WOODLANDS, Texas, Dec. 21 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today 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
|SOURCE Lexicon Pharmaceuticals, Inc.|
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