Cytokinetics Announces Completion of Enrollment in COSMIC-HF
(Thomson Reuters ONE) -
Results Expected Later This Year to Inform Potential Progression of Omecamtiv
Mecarbil to Phase III
SOUTH SAN FRANCISCO, CA, March 13, 2015 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today that COSMIC-HF (Chronic Oral Study of Myosin Activation to
Increase Contractility in Heart Failure) has completed enrollment of the
approximately 450 patients planned in the expansion phase of the clinical trial.
In addition, the company announced that over 200 patients have completed the
protocol-specified 20-week duration of dosing in this phase of the trial and
reaffirmed that results from COSMIC-HF are expected to be available in the
second half of 2015. COSMIC-HF is being conducted by Amgen in collaboration
with Cytokinetics.
"We are pleased to reach this milestone in the development program for omecamtiv
mecarbil," stated Fady I. Malik, M.D., Ph.D., Cytokinetics' Senior Vice
President, Research and Development. "COSMIC-HF will provide important
information that will inform the potential progression of omecamtiv mecarbil to
Phase III. We look forward to data from COSMIC-HF later this year and continue
to prepare with Amgen for the initiation of a potential Phase III registration
program."
Omecamtiv mecarbil is the company's lead drug candidate from its cardiac muscle
contractility program. Amgen holds an exclusive, worldwide license to omecamtiv
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization rights. Additional information on COSMIC-HF and other
completed Phase II clinical trials of omecamtiv mecarbil can be found at
www.clinicaltrials.gov.
COSMIC-HF: Phase II Clinical Trial of Oral Omecamtiv Mecarbil in Patients with
Heart Failure
COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, study
with two parts, a dose escalation phase and an expansion phase. The dose
escalation phase assessed the pharmacokinetics and tolerability of three oral
modified-release formulations of omecamtiv mecarbil in patients with heart
failure and left ventricular systolic dysfunction and was used to select one
formulation for further evaluation. During the dose escalation phase
approximately 40 patients were randomized1:1:1:1 to placebo or one of three
different oral formulations of omecamtiv mecarbil in each of two ascending dose
escalation cohorts. The dose of omecamtiv mecarbil was 25 mg twice daily in the
first escalation cohort and 50 mg twice daily in the second escalation cohort.
The dose escalation phase of COSMIC-HF completed in 2013 and informed
progression to the expansion phase.
The ongoing expansion phase of the trial has enrolled approximately 450 patients
randomized 1:1:1 to receive placebo, 25 mg, or 50 mg twice daily of omecamtiv
mecarbil. Escalation to the 50 mg dose depends on the plasma concentration
of omecamtiv mecarbil following 2 weeks of dosing with 25 mg twice daily. The
primary objective of the expansion phase of COSMIC-HF is to characterize the
safety, tolerability, and pharmacokinetics of oral omecamtiv mecarbil during 20
weeks of treatment. Secondary objectives are to assess changes from baseline in
systolic ejection time, stroke volume, left ventricular end-systolic diameter,
left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain
natriuretic peptide (a biomarker associated with the severity of heart failure)
during 20 weeks of treatment.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator and is the subject of a
collaboration between Cytokinetics and Amgen. 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 contractility is driven by the cardiac sarcomere, a highly
ordered cytoskeletal structure composed of cardiac myosin, actin and a set of
regulatory proteins, which is the fundamental unit of muscle contraction in the
heart. Cardiac myosin activators have been shown preclinically to work in the
absence of changes in intracellular calcium in cardiac myocytes by a novel
mechanism that directly stimulates the activity of the cardiac myosin motor
protein. Cardiac myosin activators appear 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 this mechanism does
not increase the velocity of cardiac contraction, but instead, increases the
systolic ejection time, resulting in an increase in cardiac contractility and
cardiac function in a potentially more oxygen-efficient manner.
About Heart Failure
Heart failure is a debilitating syndrome affecting over 5 million people in the
United States. Over 3 million patients are hospitalized each year with a primary
or secondary diagnosis of heart failure in the United States. Heart failure is
among the most common causes of hospitalization in patients over 65 years of age
and is the leading cause of rehospitalization in Medicare beneficiaries.
Despite available therapies, readmission rates for patients remain high within
one year of hospital discharge and mortality rates exceed 50% over the five-year
period following a diagnosis of heart failure. The prevalence of heart failure
is increasing with the aging population and the increased likelihood of survival
following acute myocardial infarction. The limited effectiveness of current
therapies points to the urgent need for next-generation therapeutics.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and medical
conditions. Cytokinetics is developing tirasemtiv, a fast skeletal muscle
activator, as a potential treatment for amyotrophic lateral sclerosis (ALS).
Tirasemtiv has been granted orphan drug designation and fast track status by the
U.S. Food and Drug Administration and orphan medicinal product designation by
the European Medicines Agency for the potential treatment of ALS. Cytokinetics
is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a cardiac muscle
activator, for the potential treatment of heart failure. Cytokinetics is
collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal
muscle activator, for the potential treatment of spinal muscular atrophy. Amgen
holds an exclusive license worldwide to develop and commercialize omecamtiv
mecarbil and Astellas holds an exclusive license worldwide to develop and
commercialize CK-2127107. Both licenses are subject to Cytokinetics' specified
development and commercialization participation rights. All of these drug
candidates have arisen from Cytokinetics' muscle biology focused research
activities and are directed towards the cytoskeleton. The cytoskeleton is a
complex biological infrastructure that plays a fundamental role within every
human cell. Additional information about Cytokinetics can be obtained at
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,
statements relating to Cytokinetics' and its partners' research and development
activities, including the conduct, design, enrollment, progress and results of
clinical trials, the significance and utility of preclinical data and clinical
trial results, anticipated timing for the availability of results from COSMIC-
HF, the initiation of a potential Phase III registration program for omecamtiv
mecarbil; the properties and potential benefits of Cytokinetics' drug
candidates, including omecamtiv mecarbil; and the potential market for omecamtiv
mecarbil. 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, additional clinical trials or non-clinical
studies of omecamtiv mecarbil may be required prior to its progression into
Phase III development; further clinical development of tirasemtiv will require
significant additional funding, and Cytokinetics may be unable to obtain such
additional funding on acceptable terms, if at all; 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, and Cytokinetics may be unable to obtain or
maintain patent or trade secret protection for its intellectual property;
Astellas' and Amgen's decisions with respect to the design, initiation, conduct,
timing and continuation of development activities for CK-2127107 and omecamtiv
mecarbil, respectively; Cytokinetics may incur unanticipated research and
development and other costs or be unable to obtain additional financing
necessary to conduct development of its products; Cytokinetics may be unable to
enter into future collaboration agreements for its drug candidates and programs
on acceptable terms, if at all; standards of care may change, rendering
Cytokinetics' drug candidates obsolete; competitive products or alternative
therapies may be developed by others for the treatment of indications
Cytokinetics' drug candidates and potential drug candidates may target; and
risks and uncertainties relating to the timing and receipt of payments from its
partners, including milestones and royalties on future potential product sales
under Cytokinetics' collaboration agreements with such partners. For further
information regarding these and other risks related to Cytokinetics' business,
investors should consult Cytokinetics' filings with the Securities and Exchange
Commission.
Contact:
Joanna L. Goldstein
Manager, Investor Relations & Corporate Communications
(650) 624-3000
This announcement is distributed by GlobeNewswire on behalf of
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via GlobeNewswire
[HUG#1903205]
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Datum: 13.03.2015 - 12:30 Uhr
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News-ID 378361
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