Gilead Initiates Phase III Clinical Trial of Elvitegravir, an Investigational Integrase Inhibitor for HIV
July 22 2008 - 4:15PM
Business Wire
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has
begun enrolling patients in a Phase III clinical trial of its
investigational antiretroviral agent elvitegravir (GS 9137), a
novel oral integrase inhibitor that is being evaluated for the
treatment of HIV-1 infection. The study is designed to assess the
non-inferiority of ritonavir-boosted elvitegravir, dosed once
daily, compared to raltegravir (Isentress�), another integrase
inhibitor that is dosed twice daily. The study will enroll 700
HIV-infected, treatment-experienced patients at approximately 125
sites in the United States and Puerto Rico. A second Phase III
study with a similar design involving 700 HIV-infected,
treatment-experienced patients will be initiated later this year in
Europe, Canada and Australia. �Advancing novel compounds for the
treatment of HIV/AIDS remains a key area of focus for Gilead, and
we are very pleased that our integrase inhibitor, elvitegravir,
continues to make progress with the initiation of this Phase III
clinical trial,� said Norbert Bischofberger, PhD, Executive Vice
President, Research and Development and Chief Scientific Officer,
Gilead Sciences. �As HIV patients remain on therapy for longer
periods of time, the development of resistance to existing classes
of drug is a significant concern. Based on the results observed in
our Phase II study of elvitegravir, we believe the compound may
have the potential to play an important role for patients in need
of new treatment options.� Unlike other classes of antiretroviral
agents, integrase inhibitors interfere with HIV replication by
blocking the ability of the virus to integrate into the genetic
material of human cells. About the Elvitegravir Phase III Study The
elvitegravir Phase III study is a randomized, double-blind, 48-week
clinical trial that will assess the non-inferiority of
ritonavir-boosted elvitegravir (n=350) versus raltegravir (n=350),
each administered with a background regimen in HIV-infected
treatment-experienced adults with HIV RNA (viral load) of ?1,000
copies/mL. Patients will have documented viral resistance, as
defined by International AIDS Society-USA guidelines, or at least
six months of treatment experience with two or more different
classes of antiretroviral agents prior to screening. Patients who
have previously taken an integrase inhibitor will be excluded.
Trial participants will receive either once-daily elvitegravir 150
mg or twice-daily raltegravir 400 mg. Patients� background regimens
will be based on the results of resistance testing and will include
a fully-active ritonavir-boosted protease inhibitor (PI), and a
second agent that may be a nucleoside reverse transcriptase
inhibitor (NRTI), etravirine, maraviroc or enfuvirtide. Due to
known pharmacokinetic interactions, elvitegravir patients whose
background PI is either atazanavir or lopinavir will receive an 85
mg dose of elvitegravir. The primary efficacy endpoint will be the
proportion of subjects in both arms of the study who achieve and
maintain confirmed viral load of less than 50 copies/mL through 48
weeks. Secondary endpoints will include various additional measures
of the efficacy, safety and tolerability of the two treatment
regimens. About Elvitegravir Elvitegravir, also known as GS 9137 or
JTK 303, was licensed by Gilead from Japan Tobacco Inc. (JT) in
March 2005. Under the terms of Gilead�s agreement with JT, Gilead
has exclusive rights to develop and commercialize elvitegravir in
all countries of the world, excluding Japan, where JT retains
rights. Elvitegravir is an investigational therapy and has not yet
been determined safe or efficacious in humans. About GS 9350
Because elvitegravir requires a boosting agent to allow for
once-daily dosing, Gilead is currently developing a proprietary
pharmacokinetic-enhancing compound, GS 9350, that may potentially
be used in conjunction with elvitegravir. Gilead�s goal is to
develop and bring to market a pharmacokinetic enhancer that does
not have HIV activity, can be dosed once daily, is in solid form
and is stable at room temperature, such that it can be
co-formulated with elvitegravir and Truvada� (emtricitabine and
tenofovir disoproxil fumarate) into a single tablet. A recently
completed pilot formulation study has demonstrated that this can be
achieved with GS 9350. GS 9350 is currently being evaluated in a
Phase I single and multiple dose-ranging clinical study. The study
is designed to evaluate the safety, tolerability, pharmacokinetics
and pharmacodynamics of escalating single and multiple doses of GS
9350 in healthy volunteers. GS 9350 is an investigational therapy
and has not yet been determined safe or efficacious in humans.
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 Australia. 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 risk that the clinical studies for elvitegravir and
GS 9350 may not yield positive results, which may in turn impede
the development of these compounds. 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 Annual Report
on Form 10-K for the year ended December 31, 2007 and its Quarterly
Report on Form 10-Q for the first quarter of 2008, 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. U.S. full prescribing information for Truvada is
available at www.gilead.com. Truvada is a registered trademark of
Gilead Sciences, Inc. For more information on Gilead, please call
the Gilead Public Affairs Department at 1-800-GILEAD-5
(1-800-445-3235) or visit www.gilead.com.
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