Cytokinetics Announces Presentations at the International Symposium on ALS/MND
December 02 2016 - 4:00PM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced one oral
presentation and two poster presentations at the 27th International
Symposium on ALS/MND in Dublin, Ireland. The posters will be
presented on Wednesday, December 7, 2016, and will include the
results of an international physician survey on the use of
noninvasive ventilation in the treatment of ALS, and data on a
machine learning model for the prediction of slow vital capacity,
based on datasets from BENEFIT-ALS that Origent Data Sciences
analyzed under a research collaboration with Cytokinetics that is
funded by The ALS Association. On Friday, December 9, 2016, the
baseline characteristics of patients enrolled in VITALITY-ALS will
be presented in an oral presentation.
Poster Presentations
Date: Wednesday, December 7, 2016Location: The Forum, The
Convention Centre Dublin Session: Poster Session APresentation
Time: 5:45 – 7:30 PM Poster Moderated: 6:00 – 6:20 PM Poster
Number: P203Theme: 7 - Improving Diagnosis and PrognosisTitle:
Machine Learning Model For The Prediction Of Slow Vital
CapacityPoster Presenters: David L. Ennist, Ph.D., MBA, Chief
Science Officer, Origent Data Sciences and Jinsy A. Andrews, M.D.,
Director of Neuromuscular Clinical Trials at Columbia University in
New York City
Date: Wednesday, December 7, 2016Location: The Forum, The
Convention Centre Dublin Session: Poster Session APresentation
Time: 5:45 – 7:30 PM Poster Moderated: 7:00 – 7:20 PM Poster
Number: CW3Theme: CW - Clinical Work in Progress Title:
Understanding the use of noninvasive ventilation in the treatment
of amyotrophic lateral sclerosis: results of an international
physician surveyPoster Presenter: Terry Heiman-Patterson, M.D.,
Drexel Neurological Institute, Philadelphia
Oral Presentation
Date: Friday, December 9, 2016Location: The Liffey B, The
Convention Centre Dublin Session: 9B – Clinical TrialsPresentation
Time: 9:30 – 9:45 AM Title: VITALITY-ALS, a Phase 3
trial of the fast skeletal muscle troponin activator, Tirasemtiv,
for the potential treatment of ALS: Study design and baseline
characteristicsPresenter: Jeremy M. Shefner, M.D., Ph.D., Lead
Investigator of VITALITY-ALS, Professor and Chair of Neurology at
Barrow Neurological Institute, and Professor and Executive Chair of
Neurology at the University of Arizona, Phoenix
About Cytokinetics
Cytokinetics 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 troponin 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, subject to an option held
by Astellas Pharma Inc. Cytokinetics is also
collaborating with Astellas to develop CK-2127107, a fast skeletal
muscle activator, for the potential treatment of spinal muscular
atrophy, chronic obstructive pulmonary disease and
ALS. Cytokinetics is collaborating with Amgen
Inc. to develop omecamtiv mecarbil, a novel cardiac
muscle activator, for the potential treatment of heart
failure. 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 http://www.cytokinetics.com/.
Forward-Looking Statements
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
its partners’ research and development activities, including the
conduct, design, enrollment, progress and timing of results of the
VITALITY-ALS Phase 3 clinical trial of tirasemtiv in
patients with ALS; the significance and utility of preclinical
study and clinical trial results; and the properties and potential
efficacy and safety profile of
tirasemtiv 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; the FDA and/or other regulatory authorities may not
accept effects on slow vital capacity as a clinical endpoint to
support registration of tirasemtiv for the treatment of
ALS; 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 trial 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 FDA 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; and 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
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757
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