Cytokinetics Announces First Patient Enrolled in VIGOR-ALS, an Open-Label Extension Clinical Trial of Tirasemtiv
October 18 2016 - 07:30AM
Cytokinetics, Inc. (Nasdaq:CYTK) today announced the first patient
has been enrolled in VIGOR-ALS (
Ventilatory
Investigations in
Global
Open-Label
Research in
ALS), an open-label extension clinical trial
designed to assess the long-term safety and tolerability of
tirasemtiv, in patients with ALS who have completed their
participation in VITALITY-ALS, the Phase 3 clinical trial designed
to assess the effects of tirasemtiv versus placebo on slow vital
capacity (SVC) and other measures of respiratory and skeletal
muscle function.
“People living with ALS desperately need new
therapies and VIGOR-ALS reflects our commitment to the patients
that participated in VITALITY-ALS and who contributed enormously to
the development of a potential new medicine for patients with ALS,”
said Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice
President, Research & Development. “This trial will provide
supplemental data on the effects of long-term use of
tirasemtiv.”
About VIGOR-ALS
VIGOR-ALS is an open-label extension trial of
tirasemtiv in patients with ALS who completed participation in
VITALITY-ALS. The primary endpoint of the trial is the incidence of
adverse events in the patient population. Secondary endpoints
include the time to events such as death or the first use of
assisted ventilation or respiratory insufficiency (defined as
tracheostomy or the use of non-invasive ventilation for ≥22 hours
per day for ≥10 consecutive days); decline from baseline in percent
predicted slow vital capacity (SVC), ALS functional rating
scale-revised (ALSFRS-R); and the slope of change from baseline in
percent predicted SVC and ALSFRS-R. Following enrollment, patients
will begin dosing of tirasemtiv 125 mg twice daily (250 mg/day) for
a period of 4 weeks and will titrate to their maximum tolerated
dose (based on tolerability), to no higher than 250 mg twice daily
(500 mg/day). Additional information on the trial can be found at
clinicaltrials.gov.
About ALS
Amyotrophic lateral sclerosis (ALS) is a
progressive neurodegenerative disease that afflicts approximately
30,000 people in the United States and a comparable number of
patients in Europe. Approximately 6,000 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 percent 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 currently the subject of
VITALITY-ALS, a Phase 3 clinical trial, 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 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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