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-- Data to be Presented at European Society for Medical Oncology
Congress in Madrid --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 17, 2014--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from a Phase
2 study evaluating simtuzumab, an investigational inhibitor of lysyl
oxidase-like-2 (LOXL2), in combination with gemcitabine for patients
with previously untreated advanced pancreatic cancer. In the study, the
addition of simtuzumab (200 mg or 700 mg) to gemcitabine did not
significantly increase progression-free survival (PFS) compared to
placebo plus gemcitabine. PFS was the primary endpoint of the study.
Detailed results will be presented during a poster session at the
European Society for Medical Oncology Congress (ESMO 2014) in Madrid,
Spain, September 26-30 (Abstract #5072).
In this randomized, double-blind, placebo-controlled Phase 2 trial, 236
patients with advanced pancreatic cancer received intravenous
gemcitabine plus either intravenous simtuzumab (200 mg, n=76; 700 mg,
n=79) or placebo (n=81) in cycles of 28 days. Median PFS for the
simtuzumab 200 mg, simtuzumab 700 mg and placebo groups was 3.5 months,
3.7 months and 3.7 months, respectively. The difference in PFS between
the simtuzumab and placebo arms was not statistically significant.
Expected gemcitabine-related toxicities included anemia,
thrombocytopenia, neutropenia and nausea. There was no difference in
adverse events between patients taking simtuzumab versus placebo.
“Although simtuzumab did not provide clinical benefit in
difficult-to-treat advanced pancreatic cancer patients in this study, we
continue to explore simtuzumab in other areas of unmet medical need,
with ongoing clinical trials in colorectal cancer, myelofibrosis and
serious fibrotic lung and liver diseases,” said Norbert Bischofberger,
PhD, Gilead’s Executive Vice President of Research and Development and
Chief Scientific Officer.
Simtuzumab is an investigational monoclonal antibody that is highly
selective for LOXL2, an enzyme that modifies the extracellular matrix by
promoting the cross-linking of collagen fibers. LOXL2 is thought to play
an important role in tumor progression and metastasis and in the
development of fibrotic diseases. Simtuzumab is being evaluated in
several ongoing Phase 2 trials, including in combination with FOLFIRI
for advanced colorectal cancer, in combination with ruxolitinib for
myelofibrosis, as monotherapy for idiopathic pulmonary fibrosis,
a rare lung disease, and for liver fibrosis caused by non-alcoholic
steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
Other agents in Gilead’s oncology pipeline, including momelotinib and
GS-5745, are currently being evaluated in clinical trials for the
treatment of pancreatic cancer.
Additional information about clinical studies of simtuzumab and Gilead’s
other investigational cancer agents can be found at www.clinicaltrials.gov.
Simtuzumab, momelotinib and GS-5745 are investigational products and
their safety and efficacy have not been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable results from clinical trials involving
simtuzumab in other therapeutic areas. Gilead may also experience
challenges in enrolling patients in clinical studies, requiring those
studies to be modified or delayed. Further, Gilead may make a strategic
decision to discontinue development of simtuzumab if, for example,
Gilead believes commercialization will be difficult relative to other
opportunities in its pipeline. As a result, simtuzumab may never be
successfully commercialized. These risks, uncertainties and other
factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended June 30, 2014, as filed with the U.S. Securities and
Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Investors:Patrick O’Brien, 650-522-1936Media:Nathan