Cytokinetics Announces Presentation of Data from ATOMIC-AHF at Heart Failure Society of America Annual Scientific Meeting
(Thomson Reuters ONE) -
Additional Safety and Pharmacodynamic Results Presented in Late Breaking
Clinical Trials Session
South San Francisco, CA, September 23, 2013 - Cytokinetics, Incorporated
(NASDAQ:CYTK) today announced the presentation of additional data from the
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in
Acute Heart Failure) clinical trial at a Late Breaking Clinical Trials Session
at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in
Orlando, Florida. The presentation was made by John R. Teerlink, MD, Director
of the Heart Failure Program and of the Clinical Echocardiography Laboratory at
the San Francisco Veterans Affairs Medical Center, Professor of Medicine at
University of California San Francisco and the Principal Investigator in ATOMIC-
AHF.
ATOMIC-AHF was a randomized, double-blind, placebo-controlled Phase II clinical
trial that enrolled 613 patients hospitalized with acute heart failure (AHF)
treated for 48 hours with an intravenous formulation of omecamtiv mecarbil or
placebo and designed to evaluate the safety, pharmacokinetics, pharmacodynamics,
and potential efficacy of omecamtiv mecarbil in patients with AHF. Data
presented at HFSA included details of the adjudicated myocardial infarctions in
ATOMIC-AHF and additional data from the pharmacokinetic/pharmacodynamic
relationship between increasing concentrations of omecamtiv mecarbil and
increases in echocardiographic measurements of systolic ejection time in
patients hospitalized with heart failure.
ATOMIC-AHF was conducted by Amgen in collaboration with Cytokinetics. Amgen
holds an exclusive, worldwide license to develop and commercialize omecamtiv
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization participation rights.
Results from ATOMIC-AHF Presented at HFSA Annual Meeting
Initial results from ATOMIC-AHF were recently presented at the ESC Congress
2013, organized by the European Society of Cardiology. Additional data from
ATOMIC-AHF presented today at the HFSA Annual Scientific Meeting showed that
systolic ejection time, the echocardiographic signature of omecamtiv mecarbil,
increased in a concentration-dependent manner similar to that previously
reported in healthy volunteers and stable heart failure patients. Results from
ATOMIC-AHF presented at the ESC Congress 2013 showed that rates of adverse
events (AEs), serious AEs, adjudicated deaths and hospitalizations were similar
between omecamtiv mecarbil and placebo groups. There were seven post-
randomization myocardial infarctions in the treatment groups receiving omecamtiv
mecarbil compared with three in the placebo groups (2.3 percent vs. 1.0 percent,
respectively). Data from ATOMIC-AHF presented today at the HFSA Annual
Scientific Meeting showed that four of the myocardial infarctions were observed
to be temporally remote from investigational product administration. The
estimated plasma concentrations near the time of these events are zero. Three
of these events occurred in patients who received omecamtiv mecarbil and one
occurred in a patient who received placebo. One myocardial infarction occurred
subsequent to a percutaneous coronary intervention in a patient who received
omecamtiv mecarbil. One myocardial infarction occurred in a patient with sepsis
who received placebo.
"ATOMIC-AHF extends the previously reported, encouraging results from clinical
studies of omecamtiv mecarbil conducted in healthy volunteers and in patients
with chronic stable heart failure to now include data in hospitalized patients
with acute heart failure, a group of patients with a high unmet need for a safe
compound that improves cardiac performance," stated John Teerlink, MD.
"Findings from ATOMIC-AHF provide important data to inform the design of future
efficacy trials with the intravenous formulation of omecamtiv mecarbil and also
provide support for COSMIC-HF which is currently enrolling patients with chronic
heart failure receiving the oral formulation of this promising compound."
"We are pleased to have these additional data regarding the safety and
pharmacodynamic effects from ATOMIC-AHF presented at this important heart
failure conference," stated Andrew A. Wolff, MD, Cytokinetics' Senior Vice
President of Clinical Research and Development and Chief Medical Officer. "These
data contribute to the ongoing review of results from ATOMIC-AHF and add to our
confidence that omecamtiv mecarbil appeared generally well-tolerated in a high
risk heart failure population. We look forward to additional data from the
ongoing development of this novel drug candidate which holds promise for the
potential treatment of heart failure."
Initial Results from ATOMIC-AHF Presented at ESC Congress
ATOMIC-AHF is a completed Phase II clinical trial designed to evaluate an
intravenous formulation of omecamtiv mecarbil in 613 patients enrolled in three
sequential, ascending-dose cohorts. In each cohort, patients were randomized
1:1 to omecamtiv mecarbil or placebo. The primary objective of this trial was to
evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to
placebo on dyspnea in patients with left ventricular systolic dysfunction
hospitalized for AHF. The secondary objectives were to assess the safety and
tolerability of the three dose levels of omecamtiv mecarbil compared with
placebo and to evaluate the effects of 48 hours of treatment with intravenous
omecamtiv mecarbil on additional clinical and pharmacodynamic measures.
Initial results from ATOMIC-AHF were recently presented at the ESC Congress
2013, organized by the European Society of Cardiology. ATOMIC-AHF enrolled
three, sequential, dose escalation cohorts of patients treated for 48 hours with
omecamtiv mecarbil or placebo. The primary efficacy endpoint of dyspnea symptom
response was not met; however, the study demonstrated favorable trends between
the dose and plasma concentration of omecamtiv mecarbil and dyspnea response.
The incidence of worsening heart failure within seven days of initiating
treatment appeared lower in each of the cohorts on omecamtiv mecarbil compared
to the pooled placebo group of patients. Rates of adverse events (AEs), serious
AEs, adjudicated deaths and hospitalizations were similar between omecamtiv
mecarbil and placebo groups. Omecamtiv mecarbil was not associated with an
increased incidence of tachyarrhythmias nor were heart rate or blood pressure
adversely affected.
Additional information about clinical trials of omecamtiv mecarbil can be found
at www.clinicaltrials.gov.
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 in 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 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' lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment of heart failure. Amgen Inc. holds an exclusive
license worldwide to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and commercialization
participation rights. Cytokinetics is independently developing tirasemtiv, a
fast skeletal muscle activator, as a potential treatment for diseases and
medical conditions associated with neuromuscular dysfunction. Tirasemtiv is
currently the subject of a Phase II clinical trials program and 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 amyotrophic lateral sclerosis, a
debilitating disease of neuromuscular impairment. Cytokinetics is collaborating
with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle activator
structurally distinct from tirasemtiv, for non-neuromuscular indications. 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
www.cytokinetics.com.
Forward Looking Statement
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 Amgen's research and development
activities, including the conduct and design of clinical trials; the
significance and utility of clinical trial results from ATOMIC-AHF; and the
properties and potential benefits of omecamtiv mecarbil and Cytokinetics' other
drug candidates, including the potential utility of omecamtiv mecarbil in the
potential treatment of heart failure. 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: Cytokinetics anticipates
that it will be required to conduct at least one confirmatory Phase III clinical
trial of tirasemtiv in ALS patients which will require significant additional
funding, and it 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; Amgen's and Astellas' decisions with respect to the
design, initiation, conduct, timing and continuation of development activities
for omecamtiv mecarbil and CK-2127107, 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.
Contacts:
Cytokinetics, Incorporated:
Joanna L. Goldstein
Manager, Investor Relations & Corporate Communications
(650) 624-3000
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originality of the information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
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Datum: 23.09.2013 - 22:30 Uhr
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