Cytokinetics Announces Publication of Preclinical Data Relating to CK-2127107 and Exercise Tolerance in Rodent Model of Heart Failure
(Thomson Reuters ONE) -
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 announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
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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#1897460]
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Datum: 26.02.2015 - 10:30 Uhr
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