Cytokinetics Announces Dosing of First Patient in Japan in GALACTIC-HF, Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patie...
September 19 2017 - 7:30AM
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that the
first patient has been dosed in Japan in GALACTIC-HF
(
Global
Approach to
Lowering
Adverse
Cardiac Outcomes
Through
Improving
Contractility in
Heart
Failure), the Phase 3
cardiovascular outcomes clinical trial of omecamtiv mecarbil which
is being conducted by Amgen, in collaboration with Cytokinetics.
Coincident with patient dosing, Amgen will make a $10 million
milestone payment to Cytokinetics. Omecamtiv mecarbil, a novel
investigational cardiac myosin activator that increases cardiac
contractility, is being developed by Amgen in collaboration with
Cytokinetics for the potential treatment of heart failure.
Site activation and patient dosing in Japan
follows the announcement in August of positive results from the
Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients
with heart failure. This Phase 2 clinical trial, designed to assess
the pharmacokinetics of omecamtiv mecarbil as well as its effect on
cardiac function, safety and tolerability in Japanese patients with
chronic heart failure, met its pharmacokinetic primary endpoint and
demonstrated statistically significant improvements in systolic
ejection time (SET), a secondary endpoint. The pharmacokinetics,
pharmacodynamics, safety, and tolerability data from this trial
were consistent with previously reported results from
COSMIC-HF.
About GALACTIC-HF
GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure) is a Phase 3, double-blind, randomized,
placebo-controlled multicenter clinical trial designed to determine
if treatment with omecamtiv mecarbil when added to standard of care
is superior to standard of care plus placebo in reducing the risk
of cardiovascular death or heart failure events in patients with
high risk chronic heart failure and reduced ejection fraction.
GALACTIC-HF is planned to enroll approximately 8,000 symptomatic
chronic heart failure patients in over 800 sites in 34 countries
who are either currently hospitalized for a primary reason of heart
failure or have had a hospitalization or admission to an emergency
room for heart failure within one year prior to screening.
GALACTIC-HF is being conducted under a Special Protocol Assessment
(SPA) with the U.S. FDA.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin
activator. Cardiac myosin is the cytoskeletal motor protein in the
cardiac muscle cell that is directly responsible for converting
chemical energy into the mechanical force resulting in cardiac
contraction. Cardiac myosin activators are thought to accelerate
the rate-limiting step of the myosin enzymatic cycle and shift the
enzymatic cycle in favor of the force-producing state. Preclinical
research has shown that cardiac myosin activators increase
contractility in the absence of changes in intracellular calcium in
cardiac myocytes. Omecamtiv mecarbil is being developed by Amgen in
collaboration with Cytokinetics. Amgen holds an exclusive,
worldwide license to omecamtiv mecarbil and related compounds,
subject to Cytokinetics’ specified development and
commercialization rights. Amgen has also entered an alliance with
Servier for exclusive commercialization rights in Europe as well as
the Commonwealth of Independent States, including Russia. Servier
contributes funding for development and provides strategic support
to the program.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators as potential treatments for
debilitating diseases in which muscle performance is compromised
and/or declining. As a leader in muscle biology and the mechanics
of muscle performance, the company is developing small molecule
drug candidates specifically engineered to increase muscle function
and contractility. Cytokinetics’ lead drug candidate is tirasemtiv,
a fast skeletal muscle troponin activator (FSTA). Tirasemtiv is the
subject of VITALITY-ALS, an international Phase 3 clinical trial in
patients with ALS. Tirasemtiv has been granted orphan drug
designation and fast track status by the U.S. Food and Drug
Administration (FDA) and orphan medicinal product designation by
the European Medicines Agency for the potential treatment of ALS.
Cytokinetics is preparing for the potential commercialization of
tirasemtiv in North America and Europe and has granted an option to
Astellas Pharma Inc. (“Astellas”) for development and
commercialization in other countries. Cytokinetics is collaborating
with Astellas to develop CK-2127107, a next-generation FSTA.
CK-2127107 has been granted orphan drug designation by the FDA for
the potential treatment of SMA. CK-2127107 is the subject of three
ongoing Phase 2 clinical trials enrolling patients with spinal
muscular atrophy, chronic obstructive pulmonary disease and ALS.
Astellas is also conducting a Phase 1b clinical trial of CK-2127107
in elderly adults with limited mobility. Cytokinetics is
collaborating with Amgen Inc. (“Amgen”) to develop omecamtiv
mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is
the subject of GALACTIC-HF, an international Phase 3 clinical trial
in patients with heart failure. Amgen holds an exclusive worldwide
license to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization in Europe and
certain other countries. Astellas holds an exclusive worldwide
license to develop and commercialize CK-2127107. Licenses held by
Amgen and Astellas are subject to Cytokinetics' specified
co-development and co-commercialization rights. For additional
information about Cytokinetics, visit
http://www.cytokinetics.com/.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the “Act”). Cytokinetics disclaims any intent or
obligation to update these forward-looking statements, and claims
the protection of the Act’s Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, the properties and potential benefits of Cytokinetics’
drug candidates, including omecamtiv mecarbil; the design, timing,
results and significance of the Phase 3 clinical trial of omecamtiv
mecarbil in subjects with chronic heart failure and reduced
ejection fraction in GALACTIC-HF; and the potential for eventual
regulatory approval, commercialization and launch of Cytokinetics’
product candidates. Such statements are based on management's
current expectations, but actual results may differ materially due
to various risks and uncertainties, including, but not limited to
Amgen's decisions with respect to the design, initiation, conduct,
timing and continuation of development activities for omecamtiv
mecarbil; potential difficulties or delays in the development,
testing, regulatory approvals for trial commencement, progression
or product sale or manufacturing, or production of Cytokinetics'
drug candidates that could slow or prevent clinical development or
product approval, including risks that current and past results of
clinical trials or preclinical studies may not be indicative of
future clinical trials results, patient enrollment for or conduct
of clinical trials may be difficult or delayed, Cytokinetics' drug
candidates may have adverse side effects or inadequate therapeutic
efficacy, the U.S. Food and Drug Administration or foreign
regulatory agencies may delay or limit Cytokinetics' or its
partners' ability to conduct clinical trials; Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for
its intellectual property; Cytokinetics may incur unanticipated
research and development and other costs or be unable to obtain
additional financing necessary to conduct development of its
products; standards of care may change, rendering Cytokinetics'
drug candidates obsolete; and competitive products or alternative
therapies may be developed by others for the treatment of
indications Cytokinetics' drug candidates and potential drug
candidates may target. For further information regarding these and
other risks related to Cytokinetics' business, investors should
consult Cytokinetics' filings with the Securities and Exchange
Commission. Forward-looking statements are not guarantees of future
performance, and Cytokinetics' actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Contact:CytokineticsDiane
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
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