Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA
July 21 2009 - 6:30AM
PR Newswire (US)
- Phase 2 Clinical Trial in Patients with Carcinoid Syndrome
Ongoing in U.S. - Drug Candidate Designed to Reduce Peripheral
Serotonin Production - Orphan Status in Europe Provides Potential
Regulatory and Commercial Advantages - Drug Candidate Being
Developed Under Fast Track Designation from FDA THE WOODLANDS,
Texas, July 21 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals,
Inc. (NASDAQ:LXRX), a biopharmaceutical company focused on
discovering and developing breakthrough treatments for human
disease, announced today that it has received orphan drug
designation from the Committee for Orphan Medical Products (COMP)
of the European Medicines Agency (EMEA) for LX1032, the company's
oral drug candidate for managing gastrointestinal symptoms
associated with carcinoid syndrome. LX1032 is designed to reduce
serotonin production in patients with metastatic carcinoid tumors.
Elevated levels of serotonin contribute to the gastrointestinal and
possibly other symptoms experienced by these patients. The EMEA is
a regulatory agency in the European Union (EU) primarily
responsible for the protection and promotion of public and animal
health, through the evaluation and supervision of medicines for
human and veterinary use. The goal of EMEA's orphan drug program is
to promote the development of drugs intended for the prevention or
treatment of life-threatening or chronically debilitating
conditions that affect no more than five in 10,000 people in the
EU. Incentives for developing new drugs under orphan drug
designation in the EU include 10 years of marketing exclusivity,
regulatory assistance, reduced regulatory fees associated with
applying for marketing approval, and assistance with clinical trial
design. LX1032 is the first drug candidate for which Lexicon has
obtained orphan drug status. "Gaining orphan designation in Europe
for LX1032 provides important regulatory and commercial advantages
in the development of this new drug candidate for symptoms
associated with carcinoid syndrome," said Philip Brown, M.D., J.D.,
senior vice president of clinical development at Lexicon. "We are
now well positioned to conduct trials of LX1032 in Europe as part
of an integrated global development strategy." Lexicon recently
initiated a Phase 2 clinical trial of LX1032 in the United States
to evaluate the safety and tolerability of LX1032 and its effects
on symptoms associated with carcinoid syndrome. The study is
designed as a four-week, randomized, double-blind,
placebo-controlled trial that will include up to 28 patients with
carcinoid syndrome who are symptomatic despite treatment with
currently available therapy. Up to four dose levels may be
evaluated in a serial ascending fashion. Once an optimal or maximal
dose is identified, additional patients will be added to confirm
clinical observations. In addition to LX1032, Lexicon has three
other drug candidates progressing through clinical development,
including LX1031 for irritable bowel syndrome, LX2931 for
rheumatoid arthritis, and LX4211 for diabetes. For more information
about Lexicon's clinical development programs, please visit
http://www.lexpharma.com/. LX1031 and LX1032 are being developed in
a product development collaboration with Symphony Capital Partners,
L.P. and its co-investors. About LX1032 LX1032 was discovered and
developed at Lexicon to reduce serotonin production by inhibiting
tryptophan hydroxylase (TPH), a key enzyme in the synthesis of
serotonin. Excessive levels of serotonin have been implicated in
symptoms associated with carcinoid syndrome. Serotonin's breakdown
product, 5-HIAA, is a biomarker used in the diagnosis of the
condition. In preclinical studies, LX1032 reduced peripheral
serotonin in several different species without affecting serotonin
levels in the brain. In Phase 1 clinical studies, LX1032 reduced
serotonin levels and urinary 5-HIAA in healthy volunteers
consistent with preclinical results. LX1032 is being developed
under Fast Track designation from the U.S. Food and Drug
Administration and orphan drug designation from the European
Medicines Agency. About Carcinoid Syndrome Carcinoid syndrome is a
chronic condition caused by metastatic neuroendocrine tumors that
usually originate from the gastrointestinal tract. These tumors
secrete large amounts of serotonin, which can cause a variety of
symptoms including severe diarrhea and abdominal discomfort.
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. About
Lexicon Lexicon is a biopharmaceutical company focused on
discovering and developing breakthrough treatments for human
disease. Lexicon currently has five drug candidates in development
for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and
irritable bowel syndrome, all of which were discovered by the
company's research team. The company has used its proprietary gene
knockout technology to identify more than 100 promising drug
targets. Lexicon has focused drug discovery efforts on these
biologically-validated targets to create its extensive pipeline of
clinical and preclinical programs. 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, 2008, 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: Jason Ray,
Manager, Corporate Communications and Investor Relations of Lexicon
Pharmaceuticals, Inc., +1-281-863-3225 Web Site:
http://www.lexpharma.com/
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