Cytokinetics, Incorporated (Nasdaq: CYTK), together with The Mended
Hearts, Inc. and WomenHeart: The National Coalition for Women with
Heart Disease, today announced the launch of ENACT: Empower,
Navigate, Activate for Clinical Trials, an initiative designed to
champion greater awareness and engagement in cardiovascular
clinical trials by reducing barriers, increasing support and
empowering patients in groups historically underrepresented in
clinical research, including people of color and women to
confidently navigate the clinical trial experience from start to
finish. ENACT is a joint initiative of The Mended Hearts, Inc. and
WomenHeart, made possible through grant funding from Cytokinetics
provided to each organization to address their respective
constituencies.
The goal of ENACT is to provide greater
education to patients with cardiovascular diseases participating in
clinical trials. With an initial focus on clinical trials in
hypertrophic cardiomyopathy (HCM), ENACT will offer educational
resources such as videos and written guides, and will train peer
support volunteers to help address the unique questions,
experiences and considerations people may have about clinical
trials.
ENACT is designed to develop dynamically with
the strategic direction of each partnering organization and the
needs of the communities they serve. During the initial launch, The
Mended Hearts, Inc. and WomenHeart will create complementary
content, modules and resources based on their unique expertise and
constituencies. As the program grows, new topics, offerings,
partners and funders may be introduced, all anchored in the common
goal of improving patients’ understanding, access and experiences
in cardiovascular clinical trials.
“We commend The Mended Hearts, Inc. and
WomenHeart on this joint initiative to help make cardiovascular
clinical trials more accessible, approachable and inclusive,” said
Mary Pomerantz, Cytokinetics’ Senior Director of Patient Advocacy
and Engagement. “A critical imperative within our commitment to
addressing health equity is increasing diversity in clinical
trials. ENACT is one important tool in working towards this goal by
empowering individuals with cardiovascular disease to consider
participating in clinical research, ultimately helping to promote
clinical trial populations that better reflect real-world
populations.”
“At The Mended Hearts, Inc. we are committed to
fostering a community of support and empowerment for individuals
and caregivers navigating heart disease by providing them with
compassion, education and resources,” said Denise Duch Widzgowski,
President and Chair of the Board of The Mended Hearts, Inc. “By
joining forces with WomenHeart, and thanks to the support of
Cytokinetics, we can extend our reach and the informational
resources we provide to assist patients in navigating the
complexities of the clinical trial landscape.”
“We take great pride in collaborating with The
Mended Hearts, Inc. to bring forward the ENACT initiative to
cardiovascular patients in need, and express our gratitude to
Cytokinetics for helping launch this initiative,” said Celina
Gorre, CEO of WomenHeart. “Women have historically been
underrepresented in clinical research, which can limit our
understanding of how certain treatments may affect them differently
than men. As an organization serving women with heart disease, we
hope that by encouraging more women to participate in clinical
trials, we can help advance cardiovascular care and at the same
time promote equity in clinical research.”
About The Mended Hearts,
Inc.
The Mended Hearts, Inc. (MHI) is the world’s
largest peer-to-peer cardiovascular patient support network with
nearly 100,000 members residing in 20 countries. Founded in 1951
and incorporated in 1955, MHI’s mission is “to inspire hope and
improve the quality of life of heart patients and their families
through ongoing peer-to-peer support, education, and advocacy.” For
nearly 72 years, MHI has been offering hope, support, and
encouragement to patients and families of all ages – from pre-natal
diagnosis throughout the lifespan. MHI’s three programs — Mended
Little Hearts®, Young Mended Hearts®, and Mended Hearts® — make MHI
the only organization in the world that supports patients with all
forms of cardiovascular disease throughout the entire lifespan of
the patient. MHI volunteers inspire, educate, and empower nearly
400,000 patients and family members each year through a robust
network of members who provide services and outreach in hospitals,
cardiology offices, clinics, cardiac rehab centers and local
communities.
About WomenHeart: The National Coalition
for Women with Heart Disease
WomenHeart is the only patient centered
organization serving the millions of women in the United States
living with or at risk for heart disease—the leading cause of death
in women. WomenHeart is devoted to advancing women’s heart health
through patient support, community education and advocacy. For more
information, visit www.womenheart.org.
About Cytokinetics
Cytokinetics is a late-stage, specialty
cardiovascular 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 cardiac 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 myocardial muscle
function and contractility. Cytokinetics is preparing for
regulatory submissions for aficamten, its next-in-class cardiac
myosin inhibitor, following positive results from SEQUOIA-HCM, the
pivotal Phase 3 clinical trial in obstructive hypertrophic
cardiomyopathy. Aficamten is also currently being evaluated in two
ongoing Phase 3 clinical trials: MAPLE-HCM, evaluating aficamten as
monotherapy compared to metoprolol as monotherapy in patients with
obstructive HCM and ACACIA-HCM, evaluating aficamten in patients
with non-obstructive HCM. Cytokinetics is also developing omecamtiv
mecarbil, a cardiac muscle activator, in patients with heart
failure. Additionally, Cytokinetics is developing CK-586, a cardiac
myosin inhibitor with a mechanism of action distinct from aficamten
for the potential treatment of HFpEF, and CK-136, a cardiac
troponin activator for the potential treatment HFrEF and other
types of heart failure, such as right ventricular failure resulting
from impaired cardiac contractility.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook
and YouTube.
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 express or implied relating to the
properties or potential benefits of aficamten or any of our other
drug candidates and our ability to obtain regulatory approval for
aficamten for the treatment of obstructive hypertrophic
cardiomyopathy or any other indication from FDA or any other
regulatory body in the United States or abroad. 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 the risks related to Cytokinetics’
business outlines in Cytokinetics’ filings with the Securities
and Exchange Commission. Forward-looking statements are not
guarantees of future performance, and Cytokinetics’ actual results
of operations, financial condition and liquidity, and the
development of the industry in which it operates, may differ
materially from the forward-looking statements contained in this
press release. Any forward-looking statements
that Cytokinetics makes in this press release speak only
as of the date of this press
release. Cytokinetics assumes no obligation to update its
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are
registered trademarks of Cytokinetics in the U.S. and certain other
countries.
Contact:Cytokinetics Diane WeiserSenior Vice President,
Corporate Communications, Investor Relations(415) 290-7757
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