THE WOODLANDS, Texas,
Oct. 19, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc.'s (Nasdaq: LXRX) telotristat
etiprate, the first oral therapy in development for the treatment
of carcinoid syndrome (CS), was associated with patient-reported
improvements in social and physical function and emotional
well-being according to new exit interview data from the Phase 3
TELESTAR study presented at the 2015 Neuroendocrine Tumor Society
Annual Symposium in Austin,
Texas.
Telotristat etiprate, Lexicon's most advanced product candidate,
met the TELESTAR study's primary endpoint with clinically
meaningful reductions in bowel movement frequency in cancer
patients whose carcinoid syndrome was not adequately controlled by
somatostatin analog (SSA) therapy. New data released from
interviews with participating patients who completed the randomized
treatment portion of the TELESTAR study demonstrated that these
reductions were meaningful to those patients and led to
improvements in social and physical function and emotional
well-being.
"Many patients with metastatic neuroendocrine tumors are now
able to live longer lives. Unfortunately, uncontrolled
carcinoid syndrome often makes daily life difficult for those
patients," said Pablo Lapuerta,
M.D., Lexicon Executive Vice President and Chief Medical Officer.
"We are pleased that these patient-reported experiences suggest
that telotristat etiprate may offer a meaningful benefit to the
quality of life of those patients."
Carcinoid syndrome is a rare disease affecting thousands of
cancer patients with metastatic neuroendocrine tumors that have
spread to the liver and other organs from the gastrointestinal
tract. The condition is characterized by frequent and debilitating
diarrhea, facial flushing, abdominal pain, fatigue and other
serious consequences that prevent patients from leading active,
predictable lives. 1,2
About the Exit Interview Study
TELESTAR clinical sites in five countries (Australia, Canada, England, Germany, and the
United States) invited patients prior to enrollment in the
TELESTAR study to participate in a blinded, qualitative telephone
exit interview upon conclusion of the randomized treatment portion
of the study. A total of 35 patients from 16 clinical sites
participated in the TELESTAR exit interview study and interviews
were conducted with participating patients between weeks 12 (end of
double-blind treatment phase) and 14 (open-label extension).
Participating patients were interviewed about baseline symptoms
and clinical trial experiences. Participants were also asked about
the most important and most bothersome symptoms of CS and their
daily impact, as well as about symptom improvement and its
importance. Interview data were analyzed with standard qualitative
methods using field notes and interview transcripts to examine the
responses to questions and changes in BM frequency.
Participants reported experiencing a large number of CS symptoms
before initiating the TELESTAR study. Of these, diarrhea (n = 17),
bowel movement (BM) frequency (n = 9), and urgency (n = 5) were
consistently identified as the most bothersome and important
symptoms of CS. The most frequently reported daily impact of these
symptoms was patients' inability to engage in social or physical
activities or hobbies, followed closely by the emotional impact of
CS symptoms.
According to the exit interview data, participating patients
treated with telotristat etiprate noted a reduction in BM
frequency, which they characterized as the most bothersome symptom
of CS.
"Ninety-five percent of participants – 20 out of 21 – who
reported reductions in bowel movement frequency said this reduction
was meaningful to them and allowed them to better enjoy life, leave
the house, and participate in social and other activities," said
the poster's lead author, Lowell
Anthony, M.D., FACP, Chief, Division of Medical Oncology at
University of Kentucky Markey Cancer
Center in Lexington. "This
response is very encouraging."
Furthermore, among the 33 participants (placebo:250:500 =
9:9:15) answering the interview question about treatment
satisfaction, 55 percent across all arms reported being somewhat or
very satisfied with the treatment they received during TELESTAR,
with a correlation (R = 0.66, p < 0.001) between reported change
in BM frequency and treatment satisfaction. Reports of "very
satisfied" were none (0/9) on placebo and 50 percent (12/24) on
telotristat etiprate, with similar results in the two telotristat
etiprate dosage groups.
About the TELESTAR Study
The exit interviews followed the randomized treatment portion of
the TELESTAR Phase 3 study, which enrolled 135 patients with
carcinoid syndrome that was not adequately controlled on SSA
therapy, the current standard of care. The three-arm study
evaluated two doses of oral telotristat etiprate – 250 mg and 500
mg, each taken three times daily – against placebo over a 12-week
period and measured the reduction from baseline in the average
number of daily bowel movements. Patients in both the treatment and
placebo arms continued their SSA therapy throughout the study.
Also during the Symposium, TELESTAR primary investigator,
Matthew H. Kulke, M.D., provided an
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."
Data showed that patients who added telotristat etiprate to the
standard of care 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.
Patients who received 250 mg of telotristat etiprate experienced
a reduction of 1.71 bowel movements (29 percent) in the average
number of daily bowel movements during the final week of the study
compared to baseline, and those in the 500 mg arm experienced a
reduction of 2.11 bowel movements (35 percent); the placebo group
showed a reduction of 0.87 bowel movements (17 percent). The
12-week study period is being followed by a 36-week open-label
extension where all patients receive telotristat etiprate 500 mg
three times daily.
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 metastatic neuroendocrine
tumor 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.
1Beaumont JL, Cella D, Phan AT, Choi S, Liu Z, Yao
JC. Comparison of health-related quality of life in subjects with
neuroendocrine tumors with quality of life in the general US
population. Pancreas. 2012;41 (3):461-466.
2Zuetenhorst JM, Taal BG. Metastatic carcinoid tumors: a
clinical review. Oncologist. 2005;10 (2):123-131.
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SOURCE Lexicon Pharmaceuticals, Inc.