Company Expands National and Regional Sponsorships
SOUTH SAN FRANCISCO, Calif. and WASHINGTON D.C., June 4, 2015 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq:CYTK) and The ALS Association announced an expanded partnership in which the company will provide Gold Level Sponsorship of the National Walks to Defeat ALS® as well as Platinum Level Sponsorship for ALS Association Golden West Chapter initiatives. In addition, Cytokinetics committed to a challenge grant to fund care services in the Bay Area. Cytokinetics' increased funding coincides with the culmination of ALS Awareness Month and will support The ALS Association's programs to raise awareness of the disease, honor the perseverance of patients with ALS and caregivers, and grow momentum from last year's ALS Ice Bucket Challenge.
"We are pleased to expand our national and regional partnerships with The ALS Association," stated Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "Our company remains steadfast in our resolve to serve the ALS community by increasing awareness, education and care services for patients confronting this grievous illness."
"Cytokinetics' focus on finding a treatment for ALS is crucial, and we appreciate their persistent dedication to the fight against ALS," stated Barbara Newhouse, President and Chief Executive Officer of The ALS Association. "We are grateful that the company has chosen to take its support of our activities to the next level."
"Cytokinetics' support for Chapter events, as well as the challenge grant, creates an opportunity to ensure that vital care services are available to everyone who needs them," said Fred Fisher, MSW, President and CEO, of The ALS Association Golden West Chapter.
ALS (amyotrophic lateral sclerosis) is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The disease robs people of the ability to walk, to talk and even blink an eye. It traps them inside a body they no longer can control and ultimately prevents them from breathing as it takes their life. There is no known cause of the disease, although military veterans are approximately twice as likely to develop ALS as the general population.
Tirasemtiv, a novel skeletal muscle activator, is the lead drug candidate from Cytokinetics' skeletal muscle contractility program. Tirasemtiv 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. In a recently completed Phase II study, tirasemtiv reduced the decline of slow vital capacity, a measure of respiratory function, in patients with ALS. Cytokinetics is developing tirasemtiv as a potential treatment for ALS and is preparing to advance tirasemtiv to a Phase III clinical development program that is designed to potentially confirm and extend results from prior clinical studies.
May was ALS Awareness Month, and this year The ALS Association celebrated the tremendous awareness generated from last summer's ALS Ice Bucket Challenge and the incredible impact it had on the fight against this disease. The ALS Association is grateful not only for the increased awareness about the disease but also for the $115 million in donations. Progress on how The Association is putting these dollars to work can be viewed at http://web.alsa.org/site/PageServer?pagename=ALSA_challengeALS_infographic.
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.
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics is developing tirasemtiv, a fast skeletal muscle activator, as a potential treatment for amyotrophic lateral sclerosis (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 plans to initiate a Phase III clinical trial of tirasemtiv in patients with ALS, called VITALITY-ALS. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a 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. All of these drug candidates have arisen from Cytokinetics' muscle biology focused research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at http://www.cytokinetics.com/.
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 initiation, conduct, design, and results of clinical trials, and the significance and utility of preclinical study and clinical trial results; potential markets for tirasemtiv; and the properties and potential benefits of tirasemtiv 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, including any additional Phase III trials that may be required by regulatory authorities for registration, 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, 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-2127107, 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: Carrie Munk, The ALS Association
Jenica Lancy, The ALS Association Golden West Chapter
Diane Weiser, Cytokinetics, Inc.