Item 8.01 Other Events.
Cytokinetics, Incorporated ("Cytokinetics" or the "Registrant") and The ALS
Association today announced a new release of the Pooled Resource Open-Access ALS
Clinical Trials (PRO-ACT) database updated with clinical data from Cytokinetics'
completed clinical trials in ALS including, BENEFIT-ALS (Blinded Evaluation of
Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS),
VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of
Longitudinal Indices after Treatment for a Year in ALS) and FORTITUDE-ALS
(Functional Outcomes in a Randomized Trial of Investigational Treatment with
CK-2127107 to Understand Decline in Endpoints - in ALS).
The PRO-ACT database, which is sponsored by the ALS Association and managed by
The Neurological Clinical Research Institute (NCRI) at Massachusetts General
Hospital, houses the largest ALS clinical trials dataset, containing nearly
11,000 ALS de-identified patient records from 23 completed clinical trials. The
platform harmonizes and merges anonymized data from existing publicly and
privately conducted ALS clinical trials to generate a unique, freely available
resource for the scientific community to help with finding cures for ALS. The
PRO-ACT platform was selected as the Bio-IT World's Best Practices Awards winner
in 2013 and The Clinical Informatics News Best Practices winner in Clinical Data
Intelligence category in 2015.
The PRO-ACT platform was created by Prize4Life Israel, a non-profit
organization, in partnership with the Northeast ALS Consortium (NEALS) and the
NCRI, and with initial funding from The ALS Therapy Alliance, Prize4Life, NCRI,
and The ALS Association. To date, PRO-ACT has served as the primary data source
for more than 80 publications and has been critical for numerous others. The
platform has allowed researchers to better understand disease heterogeneity,
develop novel predictive models of disease progression and has been a critical
tool to support the design of several ALS clinical trials.
About ALS
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease
that afflicts approximately 27,000 people in the United States and a comparable
number of patients in Europe. Approximately 6,300 new cases of ALS are diagnosed
each year in the United States. The average life expectancy of a person with ALS
is approximately three to five years after diagnosis and only approximately 10
percent of people with ALS 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 Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering,
developing and commercializing first-in-class muscle activators and
next-in-class muscle inhibitors as potential treatments for debilitating
diseases in which muscle performance is compromised. As a leader in muscle
biology and the mechanics of muscle performance, the company is developing small
molecule drug candidates specifically engineered to impact muscle function and
contractility. Cytokinetics is readying for the potential commercialization of
omecamtiv mecarbil, its cardiac muscle activator, following positive results
from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with
heart failure. Cytokinetics is also developing aficamten, a next-generation
cardiac myosin inhibitor, currently the subject of SEQUOIA-HCM, the Phase 3
clinical trial of aficamten in patients with symptomatic obstructive
hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in
non-obstructive HCM in Cohort 4 of the Phase 2 clinical trial, REDWOOD-HCM.
Cytokinetics is also developing reldesemtiv, an investigational fast skeletal
muscle troponin activator, currently the subject of COURAGE-ALS, a Phase 3
clinical trial in patients with amyotrophic lateral sclerosis (ALS).
Cytokinetics continues its over 20-year history of pioneering innovation in
muscle biology and related pharmacology focused to diseases of muscle
dysfunction and conditions of muscle weakness.
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About The ALS Association
The ALS Association is the only national nonprofit organization fighting ALS on
every front. By leading the way in global research, providing assistance for
people with ALS through a nationwide network of chapters, coordinating
multidisciplinary care through certified clinical care centers, and fostering
government partnerships, the Association builds hope and enhances quality of
life while aggressively searching for new treatments and a cure. For more
information about The ALS Association, visit our website at www.als.org.
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 any of our other clinical trials, statements relating to
the potential benefits of reldesemtiv, omecamtiv mecarbil, aficamten, or any of
our other drug candidates; Cytokinetics' research and development activities;
the design, timing, results, significance and utility of preclinical and
clinical results; and the properties and potential benefits of 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, 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; Cytokinetics' drug candidates may have adverse side effects or
inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may
delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics
may be unable to obtain or maintain patent or trade secret protection for its
intellectual property; 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. For further information
regarding these and other risks related to Cytokinetics' business, investors
should consult Cytokinetics' filings with the Securities and Exchange
Commission.
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