Cytokinetics Announces Publication of Preclinical Data Relating to CK-2127107 and Exercise Tolerance in Rodent Model of Heart...
26 February 2015 - 8:30PM
Manuscript Supports Rationale for Development of
CK-2127107 in Diseases Associated with Muscle Weakness and
Fatigue
South San Francisco, CA, February 26, 2015
- Cytokinetics, Incorporated (Nasdaq: CYTK)
announced the publication of a manuscript relating to its fast
skeletal muscle troponin activator CK-2127107 in The Journal of Pharmacology and Experimental
Therapeutics. This publication relates to a preclinical
evaluation of CK-2127107 in a rat model of heart failure that
demonstrated CK-2127107 was associated with increased exercise
performance in this model. Cytokinetics is developing
CK-2127107 in collaboration with Astellas Pharma Inc. ("Astellas,"
Tokyo: 4503).
"We are pleased to share
additional preclinical data on CK-2127107 that highlight the
potential application of its mechanism of action in patients with
conditions such as heart failure, which can result in exercise
intolerance due to skeletal muscle weakness and fatigue," stated
Fady I. Malik, MD, PhD, Cytokinetics' Senior Vice President,
Research and Development. "We believe that the results
summarized in this peer-reviewed manuscript support the development
of CK-2127107 in diseases and conditions characterized by muscle
weakness and fatigue."
The publication, titled "The Small
Molecule Fast Skeletal Troponin Activator, CK-2127107, Improves
Exercise Tolerance in a Rat Model of Heart Failure," appeared
online in the February edition of The Journal of
Pharmacology and Experimental Therapeutics. The objective
of the study was to investigate the effect of CK-2127107 on
skeletal muscle function and exercise performance in rats
exhibiting heart failure-mediated skeletal myopathy. In this
study, rats underwent left anterior descending coronary artery
ligation resulting in myocardial infarction and a progressive
decline in cardiac function consistent with the development of
heart failure (LAD-HF rats). Compared to sham-operated
control rats, LAD-HF rat hindlimb and diaphragm muscles exhibited
significant muscle atrophy. Fatigability was increased during
repeated contraction of the hindlimb. Exercise performance
assessed by rotarod running was lower in LAD-HF rats compared to
sham controls. Consistent with its mechanism of action,
CK-2127107 produced a leftward shift in the force-calcium
relationship of muscle fibers from diaphragm and a limb muscle, the
extensor digitorum longus. In the LAD-HF rats, a single oral
dose of CK-2127107 increased the running time of these rats to
levels comparable to those of CK-2127107 treated sham controls.
The authors concluded that CK-2127107 substantially increases
exercise performance in this heart failure model, suggesting that
modulation of skeletal muscle function by a fast skeletal troponin
activator may be a useful therapeutic approach in heart failure
associated exercise intolerance.
About
CK-2127107
Skeletal muscle contractility is
driven by the sarcomere, the fundamental unit of skeletal muscle
contraction. It is a highly ordered cytoskeletal structure composed
of several key proteins. Skeletal muscle myosin is the cytoskeletal
motor protein that converts chemical energy into mechanical force
through its interaction with actin. A set of regulatory proteins,
which includes tropomyosin and several types of troponin, make the
actin-myosin interaction dependent on changes in intracellular
calcium levels. CK-2127107, a novel skeletal muscle
activator arising from Cytokinetics' skeletal muscle contractility
program, slows the rate of calcium release from the regulatory
troponin complex of fast skeletal muscle fibers, which sensitizes
the sarcomere to calcium, leading to an increase in skeletal muscle
contractility. CK-2127107 has demonstrated pharmacological activity
that may lead to new therapeutic options for diseases associated
with muscle weakness and fatigue. CK-2127107 has been the
subject of five completed Phase I clinical trials in healthy
volunteers, which evaluated safety, tolerability, bioavailability,
pharmacokinetics and pharmacodynamics. Cytokinetics is
planning to conduct a Phase II clinical trial of CK-2127107 in
patients with SMA beginning later this year under its collaboration
with Astellas.
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/.
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' research and development activities, including
planned clinical trials and the potential significance and utility
of the results from preclinical studies and clinical trials; and
the properties and potential benefits of skeletal muscle activators
and of CK-2127107 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, further clinical
development of tirasemtiv in ALS patients 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; 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.
Contact:
Cytokinetics, Inc.
Joanna L. Goldstein (Investors &
Media)
(650) 624-3000
This
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The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Cytokinetics, Inc. via Globenewswire
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