Cytokinetics Announces Presentation Relating to Tirasemtiv and BENEFIT-ALS at International Symposium on ALS/MND
(Thomson Reuters ONE) -
South San Francisco, CA, December 2, 2013 - Cytokinetics, (Nasdaq: CYTK)
announced today that a presentation relating to tirasemtiv and BENEFIT-ALS, is
scheduled to be presented at the 24(th) International Symposium on ALS/MND to be
held December 6-8, 2013 at the Atahotel Quark in Milan, Italy. The presentation
will elaborate on the clinical trial design and include enrollment and baseline
demographics data from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects
and Functional Improvement with Tirasemtiv in ALS), which is evaluating
tirasemtiv, a novel mechanism skeletal muscle activator, as a potential
treatment for patients with amyotrophic lateral sclerosis (ALS).
Platform Presentation at the 24(th) International Symposium on ALS/MND
Date: Saturday, December 7, 2013
Location: Atahotel Quark, Aquarium Room
Presentation Time: 4:00 PM - 4:15 PM (Central European Time)
Session: 8B - Clinical Trials and Trial Design
Title: The Effect of Tirasemtiv on Functional Status in Patients with ALS
Presenter: Jeffrey M. Shefner, M.D., Ph.D., Professor and Chair, Department of
Neurology at the Upstate Medical University, State University of New York
About Tirasemtiv and BENEFIT-ALS
Tirasemtiv, a novel skeletal muscle activator, is the lead drug candidate from
the company's skeletal muscle contractility program. Tirasemtiv selectively
activates the fast skeletal muscle troponin complex by increasing its
sensitivity to calcium and, in preclinical studies, demonstrated increases in
skeletal muscle force in response to neuronal input and delays in the onset and
reductions in the degree of muscle fatigue. In previously conducted Phase IIa
clinical trials in patients with ALS, tirasemtiv appeared generally well-
tolerated, and demonstrated encouraging trends to improvement in patients'
functional abilities and increases in measures of respiratory and skeletal
muscle strength and endurance. BENEFIT-ALS is a Phase IIb, multi-national,
double-blind, randomized, placebo-controlled, clinical trial designed to
evaluate the safety, tolerability and potential efficacy of tirasemtiv in
patients with ALS.
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 to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and commercialization
participation rights. Cytokinetics is independently developing tirasemtiv, a
fast skeletal muscle activator, as a potential treatment for diseases and
medical conditions associated with 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. Cytokinetics is collaborating
with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle activator
structurally distinct from tirasemtiv, for non-neuromuscular indications. 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 planned presentations; Cytokinetics' and its partners'
research and development activities, including the conduct, design and results
of clinical trials, and the significance and utility of clinical trial results;
the properties and potential benefits of tirasemtiv and Cytokinetics' other drug
candidates, including the potential benefits of tirasemtiv in treating patients
with ALS; and the potential market for tirasemtiv. 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 and Astellas' decisions with
respect to the design, initiation, conduct, timing and continuation of
development activities for omecamtiv mecarbil and CK-2127107, respectively;
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, Investor Relations & Corporate Communications
(650) 624-3000
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire 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 GlobeNewswire
[HUG#1746907]
Unternehmensinformation / Kurzprofil:
Datum: 02.12.2013 - 13:30 Uhr
Sprache: Deutsch
News-ID 321738
Anzahl Zeichen: 8834
contact information:
Town:
SOUTH SAN FRANCISCO
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 192 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Cytokinetics Announces Presentation Relating to Tirasemtiv and BENEFIT-ALS at International Symposium on ALS/MND"
steht unter der journalistisch-redaktionellen Verantwortung von
Cytokinetics, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
