THE WOODLANDS, Texas,
Oct. 31, 2016 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced
today that the Journal of Clinical Oncology published
detailed results from Lexicon's pivotal Phase 3 TELESTAR clinical
study of telotristat ethyl in patients with carcinoid syndrome. The
article, titled "Telotristat Ethyl, a Tryptophan Hydroxylase
Inhibitor for the Treatment of Carcinoid Syndrome," is available
online at the Journal of Clinical Oncology website at
ascopubs.org/journal/jco.
"Inhibition of tryptophan hydroxylase with telotristat ethyl
represents a novel approach to reducing tumoral serotonin
production in patients with carcinoid tumors," said TELESTAR
primary investigator and lead author, Matthew H. Kulke, M.D., Director, Program in
Neuroendocrine and Carcinoid Tumors and Senior Physician, Dana
Farber Cancer Institute, and Professor of Medicine, Harvard Medical
School. "These results are encouraging for patients who
suffer from the debilitating condition of carcinoid
syndrome."
TELESTAR was a global double-blind Phase 3 study which enrolled
135 patients from 12 countries with carcinoid syndrome whose
symptoms were not adequately controlled on somatostatin analog
therapy (SSA), the current standard of care. Data show that
patients who added telotristat ethyl to SSA therapy at both the 250
mg and 500 mg doses experienced a statistically significant
reduction from baseline compared to placebo in the average number
of daily bowel movements over the 12-week study period
(p<0.001), meeting the study's primary endpoint. There was
also a statistically significant reduction in the levels of urinary
5-hydroxyindole acetic acid (5-HIAA), the main metabolite of
serotonin, from baseline to week 12 with a reduction of 40 mg/24
hours (250 mg arm) and 58 mg/24 hours (500 mg arm) versus an
increase of 11 mg/24 hours in the placebo arm (p<0.001).
Treatment with telotristat ethyl was generally well tolerated
during the double-blind treatment period.
Eighty-five percent of the patients originally enrolled in
TELESTAR opted to continue study participation, receiving treatment
with 500 mg telotristat ethyl in a 36-week open-label extension
(OLE) study. Results from the OLE showed sustained bowel
movement responses to treatment and no additional safety
signals. Additional results detailed in the publication
showed evidence that telotristat ethyl may also improve stool
consistency, reduce the urgency to defecate and reduce the use of
rescue short-acting octreotide.
"The Journal of Clinical Oncology publication provides
key data on the benefits of telotristat ethyl for patients with
carcinoid syndrome. It includes meaningful results extending out
nearly a year," said Pablo Lapuerta,
M.D., Lexicon's executive vice president and chief medical officer.
"We are very encouraged about the potential benefits
telotristat ethyl may bring in terms of bowel movement frequency
and other measures of carcinoid syndrome severity."
About Carcinoid Syndrome
Carcinoid syndrome is a rare disease affecting thousands of
cancer patients with metastatic neuroendocrine tumors (mNETs) that
have spread to the liver and other organs from the gastrointestinal
tract. The condition is characterized by frequent and debilitating
diarrhea that often prevents patients from leading active,
predictable lives, as well as by facial flushing, abdominal pain,
fatigue and, over time, heart valve damage.
About Telotristat Ethyl
Discovered using Lexicon's unique approach to gene science,
telotristat ethyl is the first investigational drug in clinical
studies to target tryptophan hydroxylase, an enzyme that triggers
the excess serotonin production within mNET cells that is a key
driver of carcinoid syndrome. While existing treatments for
carcinoid syndrome work to reduce the release of serotonin outside
tumor cells, telotristat ethyl works at the source to reduce
serotonin production within the tumor cells. By specifically
inhibiting serotonin production, telotristat ethyl seeks to control
this important driver of carcinoid syndrome and, in combination
with SSA therapy, the current standard of care, to provide patients
with more control over their disease.
Telotristat ethyl has received Fast Track and Orphan Drug
designation from the U.S. Food and Drug Administration and has been
granted priority review by the FDA with a Prescription Drug User
Fee Act (PDUFA) target action date of February 28, 2017.
Lexicon retains rights to market telotristat ethyl 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 ethyl 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 ethyl (formerly referred to as telotristat etiprate and
LX1032) and the results of and projected timing of clinical trials
and the potential therapeutic and commercial potential of
telotristat ethyl. 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 ethyl may be halted,
delayed or otherwise not demonstrate safety or efficacy, the risk
that the FDA and other regulatory authorities may not grant
regulatory approval of telotristat ethyl 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 ethyl. As a
result, telotristat ethyl 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, 2015, 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.