South San Francisco, California, December 2, 2013 – Cytokinetics announced today that a presentation relating to tirasemtiv and BENEFIT-ALS, is scheduled to be presented at the 24th International Symposium on ALS/MND to be held December 6-8, 2013 at the Atahotel Quark in Milan, Italy.
The presentation will elaborate on the clinical trial design and include enrollment and baseline demographics data from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS), which is evaluating tirasemtiv, a novel mechanism skeletal muscle activator, as a potential treatment for patients with amyotrophic lateral sclerosis (ALS).
Platform Presentation at the 24th International Symposium on ALS/MND
Date: Saturday, December 7, 2013
Location: Atahotel Quark, Aquarium Room
Presentation Time: 4:00 PM – 4:15 PM (Central European Time)
Session: 8B – Clinical Trials and Trial Design
Title: The Effect of Tirasemtiv on Functional Status in Patients with ALS
Presenter: Jeffrey M. Shefner, M.D., Ph.D., Professor and Chair, Department of Neurology at the Upstate Medical University, State University of New York
About Tirasemtiv and BENEFIT-ALS
Tirasemtiv, a novel skeletal muscle activator, is the lead drug candidate from the company’s skeletal muscle contractility program. Tirasemtiv selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium and, in preclinical studies, 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 previously conducted Phase IIa clinical trials in patients with ALS, tirasemtiv appeared generally well-tolerated, and demonstrated encouraging trends to improvement in patients’ functional abilities and increases in measures of respiratory and skeletal muscle strength and endurance. BENEFIT-ALS is a Phase IIb, multi-national, double-blind, randomized, placebo-controlled, clinical trial designed to evaluate the safety, tolerability and potential efficacy of tirasemtiv in patients with ALS.
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’ lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is in Phase II clinical development for the potential treatment of heart failure.
Amgen Inc. holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics’ specified development and commercialization participation rights. Cytokinetics is independently developing tirasemtiv, a fast skeletal muscle activator, as a potential treatment for diseases and medical conditions associated with neuromuscular dysfunction. Tirasemtiv is currently the subject of a Phase II clinical trials program and 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 amyotrophic lateral sclerosis, a debilitating disease of neuromuscular impairment.
Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle activator structurally distinct from tirasemtiv, for non-neuromuscular indications. 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 www.cytokinetics.com.
Source: Cytokinetics, Inc. via Globenewswire
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