Cytokinetics Joins Global Initiative to Recognize International Rare Disease Day
February 28 2018 - 7:30AM
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that
it is joining the global initiative to raise awareness of Rare
Disease Day®, an international campaign led by the European
Organisation for Rare Diseases (EURORDIS) and the National
Organization for Rare Disorders (NORD), dedicated to elevating the
public understanding of rare diseases. Much like the similar global
initiative in 2017, this year’s activities will focus attention on
the importance of research and will highlight the roles both
researchers and patients play in advancing research towards
potential treatments for rare diseases.
“Today we stand with EURORDIS and NORD to
recognize Rare Disease Day and shine a light on the innovations
that power research focused to novel therapies for people living
with rare diseases,” said Robert I. Blum, Cytokinetics’
President and Chief Executive Officer. “In addition to ongoing
Phase 2 clinical trials of reldesemtiv, our next-generation fast
skeletal muscle activator directed to the potential treatment of
ALS and SMA, we are also proud to be advancing three new potential
drug candidates from our research that may address needs of
patients with rare diseases.”
Cytokinetics is collaborating with Astellas to
develop reldesemtiv, a next-generation fast skeletal troponin
muscle activator (FSTA), which is the subject of four ongoing
clinical trials, including Phase 2 clinical trials directed to the
potential treatment of amyotrophic lateral sclerosis (ALS) and
spinal muscular atrophy (SMA). Results from both these clinical
trials are expected in 2018.
About Rare Disease Day
Rare Disease Day, which takes place every year
on the last day in February, was established in Europe in
2008 by the European Organisation for Rare
Diseases (EURORDIS), and is now observed in more than 80
nations. In the United States, Rare Disease Day is sponsored
by the National Organization for Rare Disorders (NORD), a
leading independent, non-profit organization committed to the
identification, treatment, and cure of rare diseases. According to
the National Institutes of Health (NIH), in the US, a
rare disease is defined as one that affects fewer than 200,000
people. With over 6,000 rare diseases, 25 million Americans are
living with a rare disease, but only 5 percent of these diseases
have a treatment.
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 SMA
SMA is a severe neuromuscular disease that
occurs in 1 in every 6,000 to 10,000 live births each year and is
one of the most common potentially fatal genetic disorders. Spinal
muscular atrophy manifests in various degrees of severity as
progressive muscle weakness resulting in respiratory and mobility
impairment. There are four types of SMA, named for age of initial
onset of muscle weakness and related symptoms: Type I (Infantile),
Type II (Intermediate), Type III (Juvenile) and Type IV (Adult
onset). Life expectancy and disease severity vary by type of
SMA. Type I patients have the worst prognosis, with a life
expectancy of no more than 2 years; Type IV patients may have a
normal life span but eventually suffer gradual weakness in the
proximal muscles of the extremities, eventually resulting in
mobility issues. Few treatment options exist for these patients,
resulting in a high unmet need for new therapeutic options to
address symptoms and modify 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 is collaborating with Amgen Inc.
(“Amgen”) 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.
Cytokinetics is collaborating with Astellas Pharma Inc.
(“Astellas”) to develop reldesemtiv (CK-2127107), a next-generation
FSTA. Reldesemtiv has been granted orphan drug designation by the
FDA for the potential treatment of SMA. Reldesemtiv is the subject
of three ongoing Phase 2 clinical trials enrolling patients with
spinal muscular atrophy, chronic obstructive pulmonary disease and
ALS. Astellas is also conducting a Phase 1b clinical trial of
reldesemtiv in elderly adults with limited mobility. Astellas holds
an exclusive worldwide license to develop and commercialize
reldesemtiv. Licenses held by Amgen and Astellas are subject to
Cytokinetics' specified co-development and co-commercialization
rights. Cytokinetics continues its 20-year history of innovation
with three new muscle biology directed compounds advancing from
research to development in 2018. 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; the design, results,
significance and utility of preclinical study 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, 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; Astellas’ decisions with respect to
the design, initiation, conduct, timing and continuation of
development activities for reldesemtiv; 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; 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:CytokineticsDiane
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
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