Cytokinetics And The ALS Association Announce Awarding Of Grant For Phase 3 Clinical Trial And Biomarker Research Collaboration

Proceeds from Ice Bucket Challenge Used to Support a Unique Collaboration Between Non-Profit, Academia and Industry

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Jul 14, 2015, 10:39 ET

SOUTH SAN FRANCISCO, Calif., and WASHINGTON, July 14, 2015 /PRNewswire-USNewswire/ -- Cytokinetics, Inc., (Nasdaq: CYTK) and The ALS Association today announced that The Association has awarded Cytokinetics a $1.5 million grant to support the collection of clinical data and plasma samples to advance the discovery of biomarkers in ALS (amyotrophic lateral sclerosis) in VITALITY-ALS, a Phase 3 clinical trial of tirasemtiv in patients with ALS. For the first time, this unique collaboration between Cytokinetics, The ALS Association, and the Barrow Neurological Institute will enable plasma samples collected from patients enrolled in a Phase 3 clinical trial to be added to The Northeastern ALS Consortium (NEALS) Repository, a resource for the academic research community to identify biomarkers that may help to assess disease progression and underlying disease mechanisms in ALS.

ALS (amyotrophic lateral sclerosis) is a progressive neurodegenerative disease that affects neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. There is no cure and no life-prolonging treatments for the disease.

"We are grateful to The ALS Association and everyone who donated to the Ice Bucket Challenge for this grant to assist the funding of VITALITY-ALS and our collaboration with Barrow Neurological Institute for biomarker research," said Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "This collaboration is an extraordinary opportunity to advance the development of tirasemtiv as well as scientific understanding of biomarkers that underlie the progression of ALS at the molecular level."

"Biomarker discovery is a major priority for ALS research, and we have recently witnessed important progress in this field," said Lucie Bruijn, Ph.D., M.B.A., Chief Scientist for The ALS Association. "We are pleased to contribute to this unique collaboration between The Association, industry and academia to progress our shared mission to improve the lives of people living with ALS through the advancement of our knowledge of ALS and through the development of potential novel treatments."

VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), which started today, is a multi-national, randomized, double-blind, placebo-controlled trial that is designed to assess the effects of tirasemtiv versus placebo on slow vital capacity and other measures of respiratory function in patients with ALS. As part of the trial, plasma samples and longitudinal clinical data will be obtained from participating patients. The clinical information and collected samples will be integrated into the NEALS Repository to support ongoing activities within the scientific community for research on biomarkers from patients with ALS. VITALITY-ALS is expected to be conducted in more than 75 centers in North America and Europe.

"VITALITY-ALS is the first industry-sponsored clinical trial in which plasma samples from patients with ALS are being collected and shared with the ALS research community," said Jeremy M. Shefner, M.D., Ph.D., Lead Investigator of VITALITY-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix. "It is especially gratifying when all of our respective interests align to serve our patients living with ALS and their caregivers."

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 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. In a recently completed Phase 2b clinical trial, tirasemtiv reduced the decline of slow vital capacity, a key measure of respiratory function in patients with ALS. Tirasemtiv is the subject of a Phase 3 clinical trial program designed to confirm and extend findings from prior studies.

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. With an unmatched understanding of 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 holds the exclusive right to develop and commercialize tirasemtiv throughout the world. 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 www.cytokinetics.com.

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SOURCE The ALS Association