Cytokinetics, Inc.: Cytokinetics Announces the Opening to Enrollment of the Expansion of COSMIC-HF

 Cytokinetics, Inc.: Cytokinetics Announces the Opening to Enrollment of the
                            Expansion of COSMIC-HF

Commencement of Next Stage in International Phase II Clinical Trialof Oral
Formulation of Omecamtiv Mecarbil in Patients with Heart Failure
South San Francisco, CA, March 28, 2014 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today that the expansion phase of the COSMIC-HF (Chronic Oral
Study of Myosin Activation to Increase Contractility in Heart Failure) has
opened to enrollment. COSMIC-HF is a Phase II double-blind, randomized,
placebo-controlled, multicenter clinical trial designed to assess the
pharmacokinetics and tolerability of omecamtiv mecarbil dosing orally in
patients with heart failure and left ventricular systolic dysfunction. The
expansion phase of COSMIC-HF will enroll 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 will depend on the plasma concentration of
omecamtiv mecarbil following two weeks of oral dosing at 25 mg twice daily.
The primary objective of the expansion phase of this trial is to characterize
the safety, tolerability, and pharmacokinetics of omecamtiv mecarbil dosed
orally during 20 weeks of treatment. The secondary objectives are to assess
the 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.
The expansion phase of COSMIC-HF is expected to enroll heart failure patients
from approximately 100 clinical sites internationally. 
COSMIC-HF is being 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.
"The opening to enrollment of the expansion phase of COSMIC-HF is an important
step forward in the evaluation of a plasma concentration-guided dose titration
strategy for omecamtiv mecarbil in patients with heart failure," stated Andrew
A. Wolff, MD, FACC, Cytokinetics' Senior Vice President of Clinical Research
and Development and Chief Medical Officer. "This international clinical trial
has the potential to inform further clinical development strategies for
omecamtiv mecarbil."
Background on COSMIC-HF 
Cytokinetics and Amgen selected an oral formulation of omecamtiv mecarbil for
the expansion phase of COSMIC-HF based on the results of the completed dose
escalation phase of COSMIC-HF. The dose escalation phase of COSMIC-HF was
designed to assess the pharmacokinetics and tolerability of three oral
modified-release formulations of omecamtiv mecarbil in patients with heart
failure and left ventricular systolic dysfunction. During the dose escalation
phase, approximately 40 patients were randomized 1:1:1:1 to placebo or one of
three different oral formulations of omecamtiv mecarbil in each of two
ascending dose escalation cohorts to enable selection of one of these oral
formulations for the expansion phase of the trial. The dose of omecamtiv
mecarbil was 25 mg twice daily in the first dose escalation cohort and 50 mg
twice daily in the second dose escalation cohort. Additional information
about COSMIC-HF 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 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 (ALS). 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.
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 and results of clinical
trials, the significance and utility of preclinical study and clinical trial
results, and the properties and potential benefits of omecamtiv mecarbil and
Cytokinetics' other drug 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, 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 decisions with respect to the design, initiation, conduct, timing and
continuation of development activities for omecamtiv mecarbil; Cytokinetics
may incur unanticipated research and development and other costs or be unable
to obtain additional financing necessary to conduct development of its
products on acceptable terms, if at all; 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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