Cytokinetics Announces Opening of COSMIC-HF, a Phase II Clinical Trial of Oral Formulations of Omecamtiv Mecarbil in Patients with Heart Failure
(Thomson Reuters ONE) -
South San Francisco, CA, February 12, 2013 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today the opening to enrollment of a Phase II clinical trial of
oral formulations of omecamtiv mecarbil. This trial, known as COSMIC-HF
(Chronic Oral Study of Myosin Activation to Increase Contractility in Heart
Failure), is sponsored by Amgen in collaboration with Cytokinetics and is
designed to evaluate the safety and efficacy of a novel cardiac muscle myosin
activator, omecamtiv mecarbil, in patients with heart failure and left
ventricular systolic dysfunction.
"We are pleased that this international Phase II clinical trial designed to
evaluate several oral formulations of omecamtiv mecarbil is now open to
enrollment," stated Andrew A. Wolff, MD, FACC, Cytokinetics' Senior Vice
President of Clinical Research and Development and Chief Medical Officer. "The
objective of this trial is to identify and characterize an oral modified-release
formulation of omecamtiv mecarbil that may progress into the Phase III clinical
program. The data from COSMIC-HF, in combination with the data from the ongoing
ATOMIC-AHF clinical trial evaluating an intravenous formulation of omecamtiv
mecarbil, will contribute to the design of a potential registration program for
this drug candidate."
Amgen holds an exclusive, worldwide license (excluding Japan) to omecamtiv
mecarbil and related compounds, subject to specified development and
commercialization participation rights of Cytokinetics.
COSMIC-HF: Phase II Clinical Trial of Omecamtiv Mecarbil:
OSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose
escalation study designed to select and evaluate an oral modified-release
formulation of omecamtiv mecarbil in patients with heart failure and left
ventricular systolic dysfunction. During the dose escalation phase,
approximately 40 patients will be randomized 1:1:1:1 to placebo or one of three
different oral formulations of omecamtiv mecarbil in each of two ascending dose
pharmacokinetic (PK) cohorts to enable selection of one of these oral
formulations for the planned expansion phase of the trial. The dose of
omecamtiv mecarbil will be 25 mg twice daily in the first PK cohort and 50 mg
twice daily in the second PK cohort. Following the dose escalation phase of the
trial, there is a planned expansion phase of the trial in which approximately
300 patients will be randomized 1:1:1 to receive one oral formulation of
omecamtiv mecarbil selected from the three studied in the prior ascending dose
PK cohorts at one of two dose levels or placebo. The two dose levels of
omecamtiv mecarbil to be studied in the expansion cohort will be based on the
data from the ascending dose PK cohorts. The primary objectives of this study
are to select an oral modified-release formulation and dose of omecamtiv
mecarbil for chronic twice daily dosing in patients with heart failure and left
ventricular systolic dysfunction and to characterize its safety, tolerability,
and pharmacokinetics after 12 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) after 12 weeks of treatment.
ATOMIC-AHF: Phase IIb Clinical Trial of Intravenous Omecamtiv Mecarbil
ATOMIC-AHF is an ongoing Phase IIb clinical trial designed to evaluate an
intravenous formulation of omecamtiv mecarbil in approximately 600 patients
enrolled in 3 sequential, ascending-dose cohorts. In each cohort, patients will
be randomized 1:1 to omecamtiv mecarbil or placebo. The primary objective of
this trial is to evaluate the effect of 48 hours of intravenous omecamtiv
mecarbil compared to placebo on dyspnea (shortness of breath) in patients with
left ventricular systolic dysfunction hospitalized for acute heart failure. The
secondary objectives are to assess the safety and tolerability of 3 dose levels
of intravenous omecamtiv mecarbil compared with placebo and to evaluate the
effects of 48 hours of treatment with intravenous omecamtiv mecarbil on
additional measures of dyspnea, patients' global assessments, change in N-
terminal pro brain-type natriuretic peptide and short-term clinical outcomes in
these patients. In addition, the trial is evaluating the relationship between
omecamtiv mecarbil plasma concentrations and these parameters in patients with
acute heart failure.
Development Status of Omecamtiv Mecarbil
In 2012, Cytokinetics and Amgen reviewed data from a prior Phase I randomized,
open-label, 4-period cross-over clinical trial designed to assess the safety,
tolerability and pharmacokinetics of multiple oral formulations of omecamtiv
mecarbil in healthy volunteers. The formulations to be evaluated in COSMIC-HF
were selected from among those oral formulations.
Prior to the conduct of the ATOMIC-AHF Phase IIb and COSMIC-HF Phase II clinical
trials, omecamtiv mecarbil was the subject of a clinical trials program
conducted by Cytokinetics comprised of five Phase I trials in healthy volunteers
and two Phase IIa trials in patients with heart failure. Those trials were
designed to evaluate the safety, tolerability, pharmacodynamic and
pharmacokinetic profiles of both intravenous and oral formulations of omecamtiv
mecarbil for the potential treatment of heart failure. Data from each of these
trials were reported previously.
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, a skeletal muscle activator, as a potential treatment for
diseases and 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' and Amgen's research and development
activities, including the progress, conduct, design and results of clinical
trials, the significance and utility of clinical trial results, and the
properties and potential benefits of omecamtiv mecarbil and Cytokinetics' other
drug candidates and potential 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.
Contact:
Joanna (Jodi) 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
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Datum: 12.02.2013 - 13:30 Uhr
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News-ID 228669
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