Cytokinetics and the ALS Association Renew Partnership to Advance the Fight Against ALS
May 03 2017 - 4:00PM
Cytokinetics, Inc. (Nasdaq:CYTK) and The ALS Association today
announced the continuation of their partnership in the fight
against ALS which includes Cytokinetics’ renewal of its Gold Level
Sponsorship of the National Walks to Defeat ALS® and Premier Level
National ALS Advocacy Conference Sponsorship as well as Platinum
Level Sponsorship for initiatives led by The ALS Association Golden
West Chapter.
“As we recognize May as ALS Awareness Month, we
are proud to continue our longstanding partnership with The ALS
Association in our shared mission to serve people living with this
devastating disease,” said Robert I. Blum, Cytokinetics’ President
and Chief Executive Officer. “It is increasingly important to step
up education, awareness and fundraising activities especially in
light of recent discoveries related to genes associated with ALS
and a growing pipeline of investigational medicines that hold great
promise.”
Over the past year, Cytokinetics has
participated in several initiatives led by The ALS Association with
the objective to accelerate the execution of clinical trials in
ALS, inform the discovery of new biomarkers for ALS and pave the
way for faster approvals of new medicines for people living with
ALS. This year, representatives of Cytokinetics will participate in
several community events with The ALS Association Golden West
Chapter including the “Champions for Care and a Cure” celebration,
the ALS Awareness Day with the San Francisco Giants, the Napa
Valley Ride to Defeat ALS and the South Bay Walk to Defeat
ALS. In addition, members of Cytokinetics’ senior management
team will attend the National ALS Advocacy Conference in May and
join with other advocates in the ALS community in meetings with
legislators on Capitol Hill on behalf of patients.
“Cytokinetics is an invaluable partner, and we
are pleased to continue our collaboration,” said Barbara Newhouse,
President and CEO of The ALS Association. “The renewal of this
partnership underscores our shared goal to improve the lives of
people with ALS.”
“We are grateful for Cytokinetics’ dedication to
the ALS community through their support of the Chapter’s vital
programs and events that benefit people diagnosed with ALS and
families in our area,” said Fred Fisher, MSW, President and CEO of
The ALS Association Golden West Chapter.
About ALS
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 approximately 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 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 troponin activator
(FSTA). Tirasemtiv is the subject of
VITALITY-ALS, an international Phase 3 clinical trial in
patients with 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. Cytokinetics is
preparing for the potential commercialization
of tirasemtiv in North
America and Europe and has granted an option
to Astellas for development and commercialization in
other countries. Cytokinetics is collaborating with
Astellas to develop CK-2127107, a next-generation fast skeletal
muscle activator. CK-2127107 is the subject of two ongoing
Phase 2 clinical trials enrolling patients with spinal muscular
atrophy and chronic obstructive pulmonary
disease. Cytokinetics is collaborating
with Amgen Inc. to develop omecamtiv mecarbil, a
novel cardiac muscle activator. Omecamtiv mecarbil is the
subject of GALACTIC-HF, an international Phase 3 clinical trial in
patients with heart failure. Amgen holds an exclusive
worldwide license to develop and commercialize omecamtiv
mecarbil with a sublicense held by Servier for
commercialization in Europe and certain other countries.
Astellas holds an exclusive worldwide license to develop and
commercialize CK-2127107. Licenses held by Amgen and
Astellas are subject to Cytokinetics' specified
co-development and co-commercialization 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 and the
Phase 2 clinical trial of CK-2127107 in patients with SMA; the
significance and utility of preclinical study and clinical trial
results; and the properties and potential efficacy and safety
profile of tirasemtiv, CK-2127107 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
(650) 624-3060
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