Lexicon Files Investigational New Drug Application for LX1032 as a Potential Treatment for Carcinoid Syndrome
December 21 2007 - 6:30AM
PR Newswire (US)
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 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. DATASOURCE: Lexicon
Pharmaceuticals, Inc. CONTACT: Bobbie Faulkner, Manager, Investor
and Public Relations of Lexicon Pharmaceuticals, Inc.,
+1-281-863-3503, Web site: http://www.lexpharma.com/
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