Cytokinetics Announces Initiation of First-Time-in-Humans, Phase I Clinical Trial of CK-2127107
(Thomson Reuters ONE) -
Second Drug Candidate from Cytokinetics' Fast Skeletal Muscle Activator Program
Begins Clinical Trial in Expanded Development Program
South San Francisco, CA, April 1, 2013 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today the initiation of a first-time-in-humans, Phase I clinical
trial of CK-2127107 in healthy male volunteers. Cytokinetics is developing CK-
2127107, a novel small molecule activator of the fast skeletal muscle troponin
complex, for the potential improvement of skeletal muscle function in diseases
and medical conditions associated with neuromuscular dysfunction, muscular
weakness, and/or muscle fatigue. Like tirasemtiv, the lead drug candidate from
the company's skeletal muscle activator program, CK-2127107 slows the rate of
calcium release from the regulatory troponin complex of fast skeletal muscle
fibers, which sensitizes the sarcomere to calcium.
CK-2127107 was discovered in connection with Cytokinetics' optimization of a
different chemical series than that which produced tirasemtiv, which is
currently being evaluated in BENEFIT-ALS (Blinded Evaluation of Neuromuscular
Effects and Functional Improvement with Tirasemtiv in ALS). BENEFIT-ALS is an
international, double-blind, randomized, placebo-controlled, Phase IIb clinical
trial designed to evaluate the safety, tolerability and potential efficacy of
tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). Advancing CK-
2127107 to Phase I evaluation in healthy subjects is consistent with
Cytokinetics' corporate strategy to characterize a potential back-up compound to
tirasemtiv in humans and to enable the evaluation of fast skeletal muscle
troponin activation in a potentially broader set of clinical indications.
The Phase I clinical trial of CK-2127107 is a double-blind, randomized, placebo-
controlled study designed to assess the safety, tolerability, and
pharmacokinetics of single ascending oral doses of CK-2127107 administered to
healthy adult males in a three period, escalating dose, crossover design. The
primary objective of this study is to determine the safety and tolerability of
single doses of CK-2127107 administered orally to healthy male volunteers. The
secondary objective is to evaluate the pharmacokinetic profile of single doses
of CK-2127107.
"This first-time-in-humans clinical trial of CK-2127107 builds on our expertise
in the biology of skeletal muscle function," stated Fady Malik, MD, PhD,
Cytokinetics' Senior Vice President, Research and Early Development. "Advancing
CK-2127107 provides us an opportunity to develop a pipeline of drug candidates
focused on skeletal muscle weakness resulting from an array of diseases
associated with muscle wasting or primary neuromuscular dysfunction."
"The initiation of this Phase I clinical trial is further demonstration of
Cytokinetics' commitment to build a portfolio of drug candidates with novel
mechanisms that leverage our expertise in the biology of the cytoskeleton and
our pioneering pharmacology associated with muscle contractility," stated Robert
I. Blum, Cytokinetics' President and CEO. "CK-2127107 is the sixth novel
chemical entity that has arisen from our research and development activities to
proceed to human clinical testing."
Background on Fast Skeletal Muscle Activators
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. The first, skeletal muscle myosin, is the
cytoskeletal motor protein that converts chemical energy into mechanical force
through its interaction with a second protein, 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.
Cytokinetics' skeletal muscle contractility program is focused to the discovery
and development of small molecule skeletal sarcomere activators and leverages
Cytokinetics' expertise gained from its ongoing discovery and development of
cardiac sarcomere activators, including the cardiac myosin activator omecamtiv
mecarbil, now in Phase IIb clinical development as a potential treatment for
heart failure. In non-clinical models, skeletal sarcomere activators have
demonstrated pharmacological activity that may lead to new therapeutic options
for diseases associated with aging, muscle wasting, and neuromuscular
dysfunction. The clinical effects of muscle wasting, fatigue and loss of
mobility can range from decreased quality of life to, in some instances, life-
threatening complications. By directly improving skeletal muscle function, a
small molecule activator of the skeletal sarcomere may potentially enhance
physical performance and quality of life in patients with conditions marked by
muscle weakness, including neuromuscular diseases such as ALS, myasthenia
gravis, cachexia, sarcopenia and general frailty associated with aging.
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 (excluding Japan) to develop and commercialize omecamtiv
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization participation rights. Cytokinetics is independently
developing tirasemtiv and CK-2127107, both fast skeletal muscle activators, as
potential treatments for diseases and medical conditions associated with aging,
muscle wasting or 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 in which treatment with tirasemtiv produced potentially
clinically relevant pharmacodynamic effects in Phase II trials. 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' research and development activities,
including the conduct, design and results of clinical trials, the significance
and utility of clinical trial results, and the properties and potential benefits
of Cytokinetics' skeletal muscle activators, including tirasemtiv and CK-
2127107, and 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, 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 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; 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, Corporate Communications & Marketing
(650) 624-3000
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via Thomson Reuters ONE
[HUG#1689285]
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Datum: 01.04.2013 - 13:33 Uhr
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News-ID 244633
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