Cytokinetics Announces Opening of Third and Final Cohort in ATOMIC-AHF
(Thomson Reuters ONE) -
Independent Data Monitoring Committee Recommends Progression in Ongoing Phase
IIb Clinical Trial of Intravenous Form of Omecamtiv Mecarbil in Patients with
Acute Heart Failure
South San Francisco, CA, November 29, 2012 - Cytokinetics, Incorporated (Nasdaq:
CYTK) announced today the opening to enrollment of the third and final cohort in
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in
Acute Heart Failure), the ongoing, international, randomized, double-blind,
placebo-controlled Phase IIb clinical trial of an intravenous formulation of
omecamtiv mecarbil. Following a review of the data from the first and second
cohorts in this ongoing Phase IIb clinical trial, the independent data
monitoring committee concluded that the current data supports progression of
this trial.
The ATOMIC-AHF clinical trial, which is being conducted by Amgen in
collaboration with Cytokinetics, is designed to evaluate the safety,
tolerability, and efficacy of omecamtiv mecarbil compared to placebo in patients
with left ventricular systolic dysfunction who are hospitalized with acute heart
failure. To date, over 400 patients have been enrolled in this trial.
Additional information about ATOMIC-AHF can be found at www.clinicaltrials.gov.
Amgen holds an exclusive, worldwide license (excluding Japan) to omecamtiv
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization participation rights.
ATOMIC-AHF Clinical Trial: Phase IIb Clinical Trial of Omecamtiv Mecarbil
ATOMIC-AHF is designed to evaluate an intravenous formulation of omecamtiv
mecarbil, a novel cardiac muscle myosin activator, in approximately 600 patients
enrolled in 3 sequential, ascending-dose cohorts. In each cohort, patients will
be randomized to receive 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 IV omecamtiv mecarbil on additional
measures of dyspnea, patients' global assessments, change in N-terminal pro
brain-type natriuretic peptide (a biomarker associated with the severity of
heart failure) and short-term clinical outcomes in these patients. In addition,
the trial will evaluate the relationship between omecamtiv mecarbil plasma
concentrations and echocardiographic parameters in patients with acute heart
failure.
Development Status of Omecamtiv Mecarbil
Prior to this Phase IIb clinical trial, omecamtiv mecarbil was the subject of a
clinical trials program comprised of multiple Phase I and Phase IIa trials
conducted by Cytokinetics. This program was 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 across the continuum of care, in both hospital and outpatient settings.
Two Phase IIa clinical trials of omecamtiv mecarbil were conducted. In addition,
five Phase I clinical trials of omecamtiv mecarbil were conducted in healthy
subjects. Data from each of these trials were reported previously.
In July 2012, Cytokinetics and Amgen reviewed data from another completed
randomized, open-label, 4-period cross-over, Phase I clinical trial designed to
assess the safety, tolerability and pharmacokinetics of multiple oral
formulations of omecamtiv mecarbil in healthy volunteers. The companies have
selected oral formulations that warrant further evaluation in patients with
heart failure. In recent months, Cytokinetics and Amgen have collaborated to
plan the manufacturing of drug product and to draft regulatory submissions to
enable the potential initiation in early 2013 of a Phase II double-blind,
randomized, placebo-controlled, multicenter, dose escalation study designed to
evaluate several modified-release oral formulations of omecamtiv mecarbil in
patients with heart failure and left ventricular systolic dysfunction. This
trial is expected to inform the potential selection of one of these oral
formulations for advancement into later-phase clinical trials.
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:
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: 29.11.2012 - 13:30 Uhr
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News-ID 208158
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