Cure SMA and Cytokinetics Inc. (Nasdaq:CYTK), a leading muscle
biology company, today announced an expanded partnership to
increase education, awareness and fundraising for spinal muscular
atrophy (SMA). As a National Gold Partner, Cytokinetics will lend
support to key national and local initiatives to advance
understanding of, and research toward potential treatments for SMA,
a genetic disease that robs people of physical strength, taking
away their ability to walk, eat or breathe.
Cytokinetics will sponsor the 2016 Annual SMA Conference, the
largest event of its kind, bringing together families affected by
SMA with researchers and clinicians, to network, learn, and
collaborate, as well as the 2016 “Hope on the Hill” Congressional
Dinner, uniting families with government and industry leaders, to
collaborate on awareness-building, advancing treatments for SMA,
and improving patient care. Locally, Cytokinetics will both sponsor
and participate in the Concert for a Cure and the Northern
California Walk-n-Roll.
“We are excited to expand on our ongoing partnership with
Cytokinetics and are gratified to have them as our National Gold
Partner,” said Kenneth Hobby, president of Cure SMA. “Cytokinetics’
contributions are crucial as we accelerate our momentum toward our
ultimate goal of a treatment and cure for SMA.”
“Building awareness and education for SMA is a priority for us
and we are pleased to take our partnership with Cure SMA to a new
level,” said Robert I. Blum, President and Chief Executive Officer
of Cytokinetics. “With no FDA-approved therapies available for
people battling SMA, we are committed to advancing CK-107 into a
Phase 2 clinical program and look forward to continued engagement
with the patient community.”
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
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 time of the 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 varies by type
of SMA from Type I, who have the worst prognosis and a life
expectancy of no more than 2 years from birth, to the Type IV, who
have a normal life span but with gradual weakness in the proximal
muscles of the extremities 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.
In collaboration with Astellas, Cytokinetics is developing
CK-2127107 (CK-107), a novel skeletal muscle troponin activator as
a potential treatment for people living with SMA and certain other
debilitating diseases and conditions associated with neuromuscular
or non-neuromuscular dysfunction, muscular weakness, and/or muscle
fatigue. CK-107 is intended to slow the rate of calcium release
from the regulatory troponin complex of fast skeletal muscle fibers
and may improve muscle function and physical performance in people
with SMA. Cytokinetics is planning to start a Phase 2 clinical
trial of CK-107 in patients with SMA later this year.
About Cure SMA
Cure SMA is dedicated to the treatment and cure of spinal
muscular atrophy (SMA)—a disease that takes away a person’s ability
to walk, eat, or breathe. It is the number one genetic cause of
death for infants.
Since 1984, Cure SMA has directed and invested in comprehensive
research that has shaped the scientific community’s understanding
of SMA. We are currently on the verge of breakthroughs in treatment
that will strengthen our children’s bodies, extend life, and lead
to a cure. We have deep expertise in every aspect of SMA—from the
day-to-day realities to the nuances of care options—and until we
have a cure, we’ll do everything we can to support children and
families affected by the disease. Learn more about how you can help
us reach a treatment and cure at www.cureSMA.org.
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. 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 and progress of the Phase 2 clinical trial of CK-107 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 CK-107 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 U.S.
Food and Drug Administration 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; Amgen's and Astellas' decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil and CK-107, respectively;
Cytokinetics may incur unanticipated research and development and
other costs or be unable to obtain additional financing necessary
to conduct development of its products; Cytokinetics may be unable
to enter into future collaboration agreements for its drug
candidates and programs on acceptable terms, if at all; 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:
Cure SMA
Megan Lenz
Communications Manager
800.886.1762 x6319
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3060
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