CYTK Cytokinetics Inc

Cytokinetics, Inc. (Nasdaq:CYTK) and The ALS Association today announced the continuation and expansion of their partnership in the fight against ALS, including Cytokinetics’ renewal of its Gold Level Sponsorship of the National Walks to Defeat ALS® and Platinum Level Sponsorship for initiatives led by The ALS Association Golden West Chapter.

“We are proud to continue and scale up our long-standing partnership with The ALS Association at both the national and local levels,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our commitment to people fighting ALS is unwavering.  Joining forces with leading advocates, we believe we can increase education, awareness and fundraising to combat this devastating disease as we further our mission to develop a potential new medicine that may make a clinically meaningful impact.”

Cytokinetics is participating in initiatives conducted by The ALS Association intended to accelerate the execution of clinical trials through innovative design approaches, and to pave the way for faster approvals of new medicines for people living with ALS. The company also recently joined The ALS Association on Capitol Hill in meetings with government officials to advocate for patients with ALS and their caregivers.

In June, The ALS Association Golden West Chapter honored Cytokinetics with the “Commitment to a Cure” Award at the chapter’s “Champions for Care and a Cure” celebration. This prestigious award was presented not only for the company’s dedication to ALS drug development, but also for its many contributions to support the ALS community and ongoing participation in community outreach events. Staff from Cytokinetics will participate in the Golden West Chapter’s upcoming ALS Awareness Day with the San Francisco Giants as well as the South Bay Walk to Defeat ALS and Napa Valley Ride to Defeat ALS.

“Cytokinetics is an invaluable collaborator of the Golden West Chapter, and we value their leadership and continuing support of vital care services for the ALS community that we serve,” said Fred Fisher, MSW, President and CEO of The ALS Association Golden West Chapter.

“Our partnership with Cytokinetics is anchored in our shared goal to help everyone affected by ALS,” said Barbara Newhouse, President and CEO of The ALS Association. “We are grateful for their tireless work in the search for an effective treatment for ALS and their commitment to our mission and vision.”

About ALS

Amyotrophic lateral sclerosis (ALS) is a progressive degenerative neuromuscular 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. In people living with ALS, motor neurons progressively die and the brain can no longer communicate with the muscles through the spinal cord. As muscles are used less and less frequently, they can atrophy, causing people with ALS to lose the ability to perform everyday activities, such as walking, speaking, and eating. The average life expectancy of an ALS patient is approximately three to five years after diagnosis and only 10% 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 the subject of a Phase 3 clinical trial program designed to confirm and extend findings on measures of respiratory function and muscle strength from prior studies.

About The ALS Association

The ALS Association is the only national non-profit organization fighting Lou Gehrig’s Disease on every front.  By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure.  For more information about The ALS Association, visit our website at www.alsa.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 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 Astellas’ option. 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, chronic obstructive pulmonary disease and ALS. 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, 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 further clinical development of tirasemtiv in ALS patients which 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 trials results; and patient enrollment for or conduct of clinical trials may be difficult or delayed. For further information regarding these and other risks related to Cytokinetics' business, investors should consult 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.

Contact:
Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757

The ALS Association
Carrie Munk
Senior Vice President, Communications & Marketing
(571) 319-3047