Cytokinetics Incorporated (NASDAQ:CYTK) today announced that
results from the expansion phase of COSMIC-HF (Chronic Oral Study
of Myosin Activation to Increase Contractility in Heart Failure), a
Phase 2 trial evaluating omecamtiv mecarbil in patients with
chronic heart failure, will be presented in the Late Breaking
Clinical Trial Session at the American Heart Association Scientific
Sessions 2015 on November 8 in Orlando, FL.
Clinical Presentation:
Date: Sunday, November 8, 2015
Session Time: 3:45-5:00 p.m. ET (Hall D)
Presentation Time: 4:31-4:40 p.m. ET
Session: LBCT.01 Failure is Not an Option: New Drugs and Systems
of Care
Presentation Title: Chronic Oral Study of Myosin Activation to
Increase Contractility in Heart Failure (COSMIC-HF): Final Results
from a Double-blind, Randomized, Placebo-controlled, Multicenter
Study
Investor Event:
The Company will host an investor meeting and
Webcast the following day, Monday, November 9, 2015 from 7:00 AM –
8:00 AM ET in Salon 10 of the Rosen Center.
Presenters include:
- Robert Blum, President & CEO, Cytokinetics
- Fady Malik, M.D., Ph.D., F.A.C.C., SVP of Research &
Development, Cytokinetics
- John Teerlink, M.D., F.A.C.C., F.A.H.A, F.E.S.C., F.R.C.P.
(London), Professor of Clinical Medicine at the University of
California San Francisco and Director of Heart Failure at the San
Francisco Veterans Affairs Medical Center
Panelists will include:
- John McMurray, M.D., F.R.C.P, F.A.C.C., F.E.S.C., F.R.S.E.,
Professor of Medical Cardiology and Honorary Consultant
Cardiologist, University of Glasgow
- Scott Solomon, M.D., Professor, Harvard Medical School,
Director, Noninvasive Cardiology, Brigham and Women’s Hospital
- Michael Felker, M.D., M.H.S., F.A.C.C., F.A.H.A., Professor of
Medicine, Chief, Heart Failure Section, Division of Cardiology,
Duke University School of Medicine
Webcast and Conference Call
Information:
Presentations and accompanying slides will be
simultaneously webcast and can be accessed through the Investors
& Media section of the Cytokinetics’ website at
www.cytokinetics.com. The live audio of the meeting will also
be accessible via telephone by dialing either (866) 999-CYTK (2985)
(United States and Canada) or (706) 679-3075 (international) and
typing in the passcode 76975790.
An archived replay of the webcast will be
available via Cytokinetics’ website until November 16, 2015. The
replay will also be available via telephone by dialing (855)
859-2056 (United States and Canada) or (404) 537-3406
(International) and typing in the passcode 76975790 from November
9, 2015 at 1:00 PM ET until November 16, 2015.
COSMIC-HF Trial Design
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase
Contractility in Heart Failure) is a double-blind, randomized,
placebo-controlled, multicenter, Phase 2 trial designed to evaluate
an oral formulation of omecamtiv mecarbil in chronic heart failure
patients with reduced ejection fraction. The trial consisted of two
parts, a dose escalation phase and a larger and longer expansion
phase. The dose escalation phase, which completed in 2013, assessed
the pharmacokinetics and tolerability of three oral
modified-release formulations of omecamtiv mecarbil and was used to
select one formulation for further evaluation in the expansion
phase. In the dose escalation phase, 96 patients were randomized
1:1:1:1 to placebo or one of three omecamtiv mecarbil oral
modified-release formulations in two cohorts (25 mg twice daily or
50 mg twice daily). Each patient cohort was followed for 35
days.
The expansion phase evaluated 448 chronic heart
failure patients with reduced ejection fraction who were dosed with
the selected oral formulation of omecamtiv mecarbil for 20 weeks
and followed for a total of 24 weeks. Patients were randomized
1:1:1 to receive either placebo or treatment with omecamtiv
mecarbil 25 mg twice daily or 25 mg with dose escalation to 50 mg
twice daily depending on plasma concentrations of omecamtiv
mecarbil after two weeks of treatment. The primary endpoints for
the expansion phase were to assess the maximum and pre-dose plasma
concentration of omecamtiv mecarbil. The secondary endpoints were
to assess 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) at week 20, as well as the safety and tolerability
of omecamtiv mecarbil including incidence of adverse events from
baseline to week 24.
COSMIC-HF was not designed to assess the impact
of omecamtiv mecarbil on cardiovascular outcomes in heart failure
patients.
COSMIC-HF was conducted by Amgen in
collaboration with Cytokinetics.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac
myosin is the cytoskeletal motor protein in the cardiac muscle cell
that is directly responsible for converting chemical energy into
the mechanical force resulting in cardiac contraction. Cardiac
myosin activators are thought to accelerate the rate-limiting step
of the myosin enzymatic cycle and shift the enzymatic cycle in
favor of the force-producing state. Preclinical research has shown
that cardiac myosin activators increase contractility in the
absence of changes in intracellular calcium in cardiac
myocytes.i, ii, iii
Omecamtiv mecarbil is being developed by Amgen
in collaboration with Cytokinetics. Amgen holds an exclusive,
worldwide license to omecamtiv mecarbil and related compounds,
subject to Cytokinetics’ specified development and
commercialization rights. Additionally, Les Laboratoires Servier
obtained an exclusive option to commercialize omecamtiv mecarbil in
Europe.
About CytokineticsCytokinetics
is a late-stage biopharmaceutical company focused on discovering,
developing and commercializing first-in-class muscle activators as
potential treatments for debilitating diseases in which muscle
performance is compromised and/or declining. As a leader in muscle
biology and the mechanics of muscle performance, the company is
developing small molecule drug candidates specifically engineered
to increase muscle function and contractility. Cytokinetics’ lead
drug candidate is tirasemtiv, a fast skeletal muscle activator, for
the potential treatment of 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 retains the right to develop and commercialize
tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to
develop omecamtiv mecarbil, a novel 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. For
additional information about Cytokinetics, visit
www.cytokinetics.com.
Forward-Looking StatementsThis
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 its partners’ research and development
activities, including the significance and utility of
COSMIC-HF clinical trial results and the potential
progression of omecamtiv mecarbil to Phase 3 development; and the
properties and potential benefits of Cytokinetics' 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 Amgen's decisions with
respect to the design, initiation, conduct, timing and continuation
of development activities for omecamtiv mecarbil; 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; Cytokinetics may incur unanticipated research and
development and other costs or be unable to obtain additional
financing necessary to conduct development of its products;
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.
Forward-looking statements are not guarantees of future
performance, and Cytokinetics' actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Cytokinetics assumes no obligation to update its forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
i Malik FI, Hartman JJ, Elias KA, et al. Cardiac myosin
activation: a potential therapeutic approach for systolic heart
failure. Science. 2011;331(6023):1439-1443.
ii Shen YT, Malik FI, Zhao X, et al. Improvement of Cardiac
Function by a Cardiac Myosin Activator in Conscious Dogs With
Systolic Heart Failure. Circ Heart Fail. 2010;3(4):522-527.
iii Malik FI, Morgan BP. Cardiac myosin activation part 1:
From concept to clinic. J Mol Cell Cardiol. 2011;51:454-461.
CONTACT: Cytokinetics, South San Francisco
Diane Weiser, 650-624-3060 (investors and media)
Cytokinetics (NASDAQ:CYTK)
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