Cytokinetics to Ring Nasdaq Closing Bell to Launch ALS Awareness Month
02 May 2016 - 9:30PM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced that it will ring
the Closing Bell at Nasdaq this afternoon in recognition of ALS
Awareness Month and the company’s commitment to education,
awareness, research and development activities focused to
amyotrophic lateral sclerosis (ALS). Cytokinetics’ senior
leadership team will be joined in this symbolic act by the
leadership of the National, Golden West and New York Chapters of
The ALS Association as well as people living with ALS and their
loved ones.
“These are promising and hopeful times for both
our company and the ALS community and we are honored to ring in ALS
Awareness Month in recognition of the great strides we are taking
to urgently advance the development of an investigational medicine
for the potential treatment of ALS,” said Robert I. Blum,
Cytokinetics’ President and Chief Executive Officer. “We look
forward to joining the ALS community on Capitol Hill next week to
meet with government officials and advocate for increased
education, awareness and funding on behalf of ALS patients and
caregivers.”
Cytokinetics is evaluating tirasemtiv, a potential treatment for
people living with ALS, in VITALITY-ALS, an international Phase 3
clinical trial designed to assess the effects of tirasemtiv versus
placebo on slow vital capacity and other measures of skeletal
muscle strength in patients with ALS. The trial is expected
to enroll patients in more than 75 centers in 11 countries and is
anticipated to complete enrollment in the second quarter of
2016.
In addition to clinical development,
Cytokinetics is actively participating in initiatives led by The
ALS Association involving leading clinicians, researchers, industry
representatives and people living with ALS, to inform guidance to
help accelerate the execution of ALS clinical trials through
innovative design approaches, and to pave the way for faster
approvals of new medicines for people living with ALS.
Cytokinetics entered into a research
collaboration with Origent Data Sciences, Inc., a market leader in
patient-level predictive modeling for neurological conditions
including ALS, to refine and prospectively validate an Origent
computer model to predict the course of ALS disease progression
leveraging data from Cytokinetics’ clinical trials of tirasemtiv.
Funded by Origent’s receipt of a grant from The ALS Association,
this joint research program will enable the first prospective
validation of the predictive model in a clinical trial setting.
In addition, The ALS Association has awarded Cytokinetics a
grant to support the collection of clinical data and plasma samples
to advance the discovery of biomarkers in ALS. The
collaboration between Cytokinetics, The ALS Association, and the
Barrow Neurological Institute will enable plasma samples collected
from patients enrolled in VITALITY-ALS to be added to The
Northeastern ALS Consortium (NEALS) Repository, a resource for the
academic community to identify biomarkers that may help to assess
disease progression and underlying disease mechanisms in ALS.
About ALS
Amyotrophic lateral sclerosis (ALS) is a
progressive neurodegenerative disease that afflicts approximately
25,000 people in the United States and a comparable number of
patients in Europe. Approximately 5,600 new cases of ALS are
diagnosed each year in the United States. The average life
expectancy of an ALS patient is approximately three to five years
after diagnosis and only 10% of patients survive for more than 10
years. Death is usually due to respiratory failure because of
diminished strength in the skeletal muscles responsible for
breathing. Few treatment options exist for these patients,
resulting in a high unmet need for new therapies to address
functional deficits and disease progression.
About Tirasemtiv
Tirasemtiv, a novel skeletal muscle activator,
selectively activates the fast skeletal muscle troponin complex by
increasing its sensitivity to calcium and, in preclinical studies
and early clinical trials, demonstrated increases in skeletal
muscle force in response to neuronal input and delays in the onset
and reductions in the degree of muscle fatigue. Tirasemtiv has been
studied in clinical trials that have enrolled over 1000 people
internationally. Tirasemtiv is the subject of a Phase 3 clinical
trial program designed to confirm and extend findings on measures
of respiratory function and muscle strength from prior studies.
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 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 and chronic obstructive pulmonary
disease. 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 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 initiation, conduct, design,
enrollment, progress, continuation, completion and results of
clinical trials, the significance and utility of preclinical study
and clinical trial results; the expected availability of clinical
trial results; 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 further clinical development of tirasemtiv in ALS
patients which 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 trials results; and patient
enrollment for or conduct of clinical trials may be difficult or
delayed. 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.
Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3060
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