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2014-04-22

Cytokinetics, Inc.: Cytokinetics Announces Results From BENEFIT-ALS Will Be Presented at the 66th Annual Meeting of the American Academy of Neurology

South San Francisco, CA, April 22, 2014

-
Cytokinetics, Incorporated (Nasdaq: CYTK) announced today that results from
BENEFIT-ALS (B
linded E
valuation of N
euromuscular E
ffects and F
unctional I
mprovement with T

irasemtiv inAL
S) will be presented during a Platform Session scheduled at the 66thAnnual
Meeting of the American Academy of Neurology (AAN) to be held April 26 - May
3, 2014 at the Pennsylvania Convention Center in Philadelphia, PA.
Cytokinetics also announced that additional poster presentations related
totirasemtiv
and ALS will be presented at AAN.

Platform Session Presentation at the 66thAnnual Meeting of the American
Academy of Neurology

Title: The Effect ofTirasemtiv
on Functional Status in Patients with ALS

Presenter: Jeremy M. Shefner, M.D., Ph.D
Date: Tuesday, April 29, 2014
Presentation Time: 4:15 PM (Eastern Time)
Session: S16.005 - 5LB.001 - Platform Session: Neuromuscular and Clinical
Neurophysiology

AboutTirasemtiv
and BENEFIT-ALS

Tirasemtiv
, a novel skeletal muscle activator, is the lead drug candidate from
Cytokinetics' 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 amyotrophic lateral
sclerosis (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 an international, double-blind, randomized, placebo-controlled,
Phase IIb clinical trial which was designed to evaluate the safety,
tolerability and potential efficacy oftirasemtiv
in patients with ALS. Patients enrolled in BENEFIT-ALS began treatment with
open-label dosing of tirasemtiv
at 125 mg twice daily. Patients who tolerated open-label treatment for one
week were randomized to receive 12 weeks of double-blind treatment with
twice-daily oral ascending doses of tirasemtiv
or placebo, beginning at 125 mg twice daily and increasing weekly up to 250
mg twice daily (or a dummy dose titration with placebo). Clinical
assessments occurred monthly during double-blind treatment; patients also
returned for follow-up evaluations at one and four weeks after their final
dose of double-blind study medication. The primary efficacy analysis of
BENEFIT-ALS compares the mean change from baseline in the ALS Functional
Rating Scale in its revised form (ALSFRS-R) on tirasemtiv
versus placebo. Secondary endpoints include Maximum Voluntary Ventilation
(MVV) and other measures of respiratory and skeletal muscle function and
fatigability.

Additional Poster Presentations at the 66thAnnual Meeting of the American
Academy of Neurology

Title: Fast Skeletal Muscle Troponin ActivatorTirasemtiv
Increases Muscle Function and Performance in the B6SJL SOD1G93A ALS Mouse
Model

Presenter: Fady I. Malik, M.D., Ph.D., F.A.C.C.
Date: Monday, April 28, 2014
Presentation Time: 3:00 PM (Eastern Time)
Session: P1.081 - Poster Session I: Anterior Horn Cell Disease: Pathogenesis
and Pathology
Poster on Display: 3:00 PM - 6:30 PM (Eastern Time)

Title: Tirasemtiv
Amplifies Skeletal Muscle Response to Nerve Activation in Humans

Presenter: Fady I. Malik, M.D., Ph.D., F.A.C.C.
Date: Wednesday, April 30, 2014
Presentation Time: 7:30 AM (Eastern Time)
Session: P4.077 - Poster Session IV: ALS: Trials and Biomarkers
Poster on Display: 7:30 AM - 11:00 AM (Eastern Time)

Title: Profile of Medical Care Costs in Patients with Amyotrophic Lateral
Sclerosis in Medicare Program and Under Commercial Insurance
Presenter: Lisa Meng, Ph.D.
Date: Thursday, May 1, 2014
Presentation Time: 3:00 PM (Eastern Time)
Session: P7.102 - Poster Session VII: Neuromuscular Health Services/Outcomes
Research
Poster on Display: 3:00 PM - 6:30 PM (Eastern Time)

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
commercializeomecamtiv mecarbil
and related compounds, subject to Cytokinetics' specified development and
commercialization participation rights. Cytokinetics is independently
developingtirasemtiv
, 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
(ALS). 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, and the properties
and potential benefits 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, Cytokinetics anticipates that it will be
required to conduct at least one confirmatory Phase III clinical trial of
tirasemtiv in ALS patients if supported by the BENEFIT-ALS data, 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; 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 NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Cytokinetics, Inc. via Globenewswire

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