Gilead Announces Data for Genotype 1 Null Responder Hepatitis C Patients Enrolled in ELECTRON Study
February 17 2012 - 6:01AM
Business Wire
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that the
majority of hepatitis C genotype 1 patients with a prior “null”
response to an interferon (IFN)-containing regimen enrolled in the
ongoing ELECTRON study experienced viral relapse within four weeks
of completing 12 weeks of treatment with GS-7977 plus ribavirin
(RBV). Ten patients were randomized to this arm of the ELECTRON
study and data are available for eight of the 10 patients at this
time. Among these eight patients, six have experienced viral
relapse. Two patients have not relapsed; however, they have only
reached the two week post-treatment time point.
“These data answer an important question about the use of
GS-7977 and ribavirin for the treatment of genotype 1 null
responder patients, suggesting that additional direct acting
antivirals may be necessary to effectively treat this patient
population,” said Norbert Bischofberger, PhD, Executive Vice
President of Research and Development and Chief Scientific Officer.
“We will continue to explore a number of therapeutic approaches to
address this significant unmet medical need, including combinations
with other oral antivirals.”
GS-7977 is a nucleotide analog polymerase inhibitor that is
currently being studied for the treatment of chronic hepatitis C. A
number of ongoing Phase 2 and Phase 3 studies are evaluating the
safety and efficacy of the compound with and without RBV and/or
pegylated interferon (Peg-IFN) in patients with genotypes 1-6 who
are treatment naïve, treatment experienced, or have had a “null”
response to Peg-IFN.
Genotype 2 and 3 data from the ELECTRON study were presented at
the 62nd annual meeting of the American Association for the Study
of Liver Diseases (The Liver Meeting 2011). Data from the genotype
1 null responder arm of the study will be presented at an upcoming
scientific conference.
Results from ongoing studies in genotype 1 treatment-naïve
patients will be available in the coming months. The first data
evaluating GS-7977 plus RBV for 12 weeks in genotype 1 naïve
patients will come from an arm of the QUANTUM study with 25
patients at the end of the first quarter of 2012. This will be
followed in the second quarter by data from the ELECTRON study
involving 25 patients and, early in the third quarter, data on
GS-7977 and RBV treatment for 24 weeks from an arm of the QUANTUM
study will become available.
Conference Call
Gilead will host a conference call today, February 17, 2012 at
8:00 a.m. Eastern Time, to discuss these study results. To access
the live call, please dial 1-866-825-1709 (U.S.) or 1-617-213-8060
(international). The conference passcode number is 71588571.
Telephone replay is available approximately one hour after the call
through 11:59 p.m. Eastern Time, February 20, 2012. To access,
please call 1-888-286-8010 (U.S.) or 1-617-801-6888
(international). The conference passcode number for the replay is
64278864. The information provided on the teleconference is only
accurate at the time of the conference call, and Gilead will take
no responsibility for providing updated information.
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 America, Europe and Asia Pacific.
Forward-Looking
Statement
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 the ELECTRON
and QUANTUM studies, including in genotype 1 treatment-naïve
patients, as well as other clinical trials evaluating GS-7977 with
or without RBV and/or Peg-IFN or in combination with other
antivirals; the anticipated timing for receiving clinical data and
making regulatory filings; and Gilead’s ability to develop an
all-oral antiviral regimen for HCV genotype 1 patients or a
pangenotypic regimen for all HCV patients. As a result, GS-7977 may
never be successfully commercialized. Further, Gilead may make a
strategic decision to discontinue development of GS-7977 if, for
example, it believes commercialization will be difficult relative
to other opportunities in its pipeline. 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
September 30, 2011, 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 or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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