THE WOODLANDS, Texas,
Oct. 9, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
announced that data from the TELESTAR Phase 3 clinical study of
telotristat etiprate has been accepted for presentation at the
North American Neuroendocrine Tumor Society annual symposium to be
held from October 15-17, in
Austin, Texas. In addition, data
from interviews with patients who completed the randomized
treatment portion of the TELESTAR study will be presented for the
first time in a poster session.
Telotristat etiprate, which has received Fast Track and Orphan
Drug designation from the U.S. Food and Drug Administration, is in
development for the treatment of carcinoid syndrome in cancer
patients whose symptoms are not adequately controlled by
long-acting somatostatin analog therapy, the current standard of
care.
The oral presentation, entitled "Results of TELESTAR: A Phase 3,
Randomized, Placebo-controlled, Double-blind Study to Evaluate the
Efficacy and Safety of Telotristat Etiprate in Patients with
Carcinoid Syndrome Not Adequately Controlled by Somatostatin
Analog," will be presented at the Clinical Science Symposium at
8:30 a.m. CDT, on October 16, by primary investigator, Matthew H. Kulke, M.D., Director, Program in
Neuroendocrine and Carcinoid Tumors and Senior Physician, Dana
Farber Cancer Institute, and Associate Professor of Medicine,
Harvard Medical School.
The poster, entitled "Assessing Treatment Benefit of Telotristat
Etiprate in Patients with Carcinoid Syndrome: Patient Exit
Interviews," will be presented during the poster session at
6 p.m. CDT, on October 16.
About Telotristat Etiprate
Discovered using Lexicon's unique approach to gene science,
telotristat etiprate is the first investigational drug in clinical
studies to target tryptophan hydroxylase, an enzyme that triggers
the excess serotonin production within mNET cells that leads to
carcinoid syndrome. While existing treatments for carcinoid
syndrome work to reduce the release of serotonin outside tumor
cells, telotristat etiprate works at the source to reduce serotonin
production within the tumor cells. By specifically inhibiting
serotonin production, telotristat etiprate seeks to control this
important driver of carcinoid syndrome and, in turn, provide
patients with more control over their disease.
Lexicon retains rights to market telotristat etiprate in the
U.S. and Japan, and is building
the in-house commercial infrastructure to serve the U.S. market.
Lexicon has a license and collaboration agreement with Ipsen to
commercialize telotristat etiprate in Europe and other countries outside the U.S.
and Japan.
About Lexicon
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science based on Nobel
Prize-winning technology to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
identified more than 100 protein targets with significant
therapeutic potential in a range of diseases. Through the precise
targeting of these proteins, Lexicon is pioneering the discovery
and development of innovative medicines to safely and effectively
treat disease. Lexicon has a pipeline of promising drug candidates
in clinical and pre-clinical development in oncology, diabetes and
metabolism. For additional information please visit
www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development of
telotristat etiprate (LX1032) and the results of and projected
timing of clinical trials and the potential therapeutic and
commercial potential of telotristat etiprate. In addition,
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 the risk that clinical studies of
telotristat etiprate may be halted, delayed or otherwise not
demonstrate safety or efficacy, the risk that Lexicon and its
licensees may be unable to file for regulatory approval of
telotristat etiprate with the FDA and other regulatory authorities
in accordance with its currently anticipated timelines, the risk
that the FDA and other regulatory authorities may not grant
regulatory approval of telotristat etiprate in accordance with
Lexicon's currently anticipated timelines or at all, and the risk
that such regulatory approvals, if granted, may have significant
limitations on the approved use of telotristat etiprate. As a
result, telotristat etiprate may never be successfully
commercialized. Other risks include Lexicon's ability to meet
its capital requirements, successfully conduct preclinical
and clinical development and obtain necessary regulatory
approvals of its other potential drug candidates, 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. Any of these risks, uncertainties and other
factors 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 "Risk Factors" in Lexicon's
annual report on Form 10-K for the year ended December 31, 2014, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.