Cytokinetics and The ALS Association Announce Awarding of Grant for Phase 3 Clinical Trial and Biomarker Research Collaboration

July 14, 2015

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.

“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.”

Read the Press Release.

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